Category Archives: Biotechnology

Bill to boost medical research comes with a catch

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United States Capitol BuildingThe House of Representatives pass a bill Friday that could give a big cash infusion to medical research, which has been struggling in recent years.

But the bill would also tweak the government’s drug approval process in a way that makes some researchers nervous.

Despite those worries, many scientists are cheering on the legislation.

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How good are online symptom checkers? Not very . . .

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How Symptom Checkers Do:

Websites scored on the basis of the rate at which each tool got a diagnosis correct in the first three suggestions

Best Performing:

  • Symcat – 75 percent
  • Isabel – 69 percent
  • AskMD – 68 percent

Worst Performing:

  • BetterMedicine – 29 percent
    Earlydoc – 33 percent
    Symptomate and Esagil – 34 percent

Source: Harvard Medical School study in the BMJ (full table page 11)

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States move to limit patient costs for high-priced drugs

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pills-spill-out-of-bottle

By Michael Ollove
Stateline

As more expensive specialty drugs come on the market to treat some of the most serious chronic diseases, more states are stepping in to cushion the financial pain for patients who need medicine that can cost up to hundreds of thousands of dollars a year. Continue reading

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If this vaccine fights cancer, why aren’t more people embracing it?

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Human Papilloma Virus

By Meredith Li-Vollmer 
Public Health – Seattle & King County

If you knew there was a vaccine that could prevent several types of cancer—including a form of cancer that kills over 250,000 women each year—would you make sure your child gets it?

Consider this:

  • An estimated 79 million Americans are infected with Human Papilloma Virus (HPV) that causes a range of cancers, as well as genital warts.
  • HPV is so common that most females and males will become infected with at least one type of HPV in their lifetime.

But there is some incredibly good news: the HPV vaccine prevents infections from HPV, and an updated HPV vaccine protects against more than twice the number of strains of HPV than the previous version.

Yes, this vaccine prevents cancer. Continue reading

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Google Glass in the ER? Health care moves one step closer to Star Trek

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Photo by Antonio Zugaldia CC.

Photo by Antonio Zugaldia CC.

By Lisa Gillespie
KHN

Imagine walking into an emergency room with an awful rash and waiting hours to see a doctor until, finally, a physician who doesn’t have specific knowledge of your condition gives you an ointment and a referral to a dermatologist.

That could change if a technological device like Google Glass, which is a wearable computer that is smaller than an ink pen and includes a camera function, could be strapped to an emergency room doctor’s head or to his or her eyeglasses and used to beam a specialist in to see patients at the bedside.

Not only would a patient get a more specific initial diagnosis and treatment, but a second visit to a dermatologist might not be necessary.

Researchers did just this for a small sample of people at the emergency room of the Rhode Island Hospital in Providence.

They found during the course of the study that 93.5 percent of patients who were seen with a skin problem liked the experience, and 96.8 percent were confident in the accuracy of the video equipment and that their privacy was protected. Continue reading

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Heart on a chip

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University of California, Berkeley researchers, led by bioengineering professor Kevin Healy, have been able to test heart drugs on human cardiac muscle cells housed in an inch-long silicone device.

The video shows cardiac muscle cells before and after exposure to isoproterenol, a drug used to treat certain heart ailments, including bradycardia (slow heart rate). It’s clear that the cells beat faster after 30 minutes of exposure to isoproterenol.The study’s lead author is Anurag Mathur.

The project is funded through the Tissue Chip for Drug Screening initiative, an interagency collaboration launched by the National Institutes of Health to develop 3-D human tissue chips that model the structure and function of human organs.

“Ultimately, these chips could replace the use of animals to screen drugs for safety,” said Healy.

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Safety advocate sees ‘hope and hype’ In digital revolution

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"Robert Wachter, MD"By Michelle Andrews
KHN

Dr. Robert Wachter is a long-time patient safety advocate who has written extensively about the trends affecting quality and safety in health care.

Wachter, associate chair of the University of California-San Francisco department of medicine, years ago coined the term “hospitalist” and predicted the rise of that profession.

In his new book, “The Digital Doctor: Hope, Hype and Harm at the Dawn of Medicine’s Computer Age,” he turns his attention to technology in health care, and the risks and rewards as we digitize everything from medical records to office visits.

We talked recently about his new book. This is an edited and condensed version of that conversation.’

Q. As I read your book I couldn’t help thinking about the elderly. Many older people aren’t tech savvy. They’re intimidated by looking up information on computers, sending email to their doctors and the like. They’re also bigger health care users than many younger people. What needs to be done to help them get and stay engaged as technology advances?

Photo: Dr. Robert Wachter by Susan Merrell/UCSF)

Continue reading

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More states demand notification of use of biosimilars

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Three red-and-white capsulesBy Michael Ollove
Stateline

Without the medicine Rachelle Crow takes for her rheumatoid arthritis, the 29-year-old Michigan woman’s face would frequently feel as if it were engulfed in flames. She would barely be able to crawl out of bed. She would have trouble opening or closing her fists or lifting her 3-year-old daughter.

Crow can do all those things thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.

Notification laws require that patients and doctors are told whenever “biosimilar” imitations are substituted for brand-name biologics

.What keeps her up at night is a fear that a pharmacy could substitute a cheaper, not-quite identical drug for Cimzia without her or her doctor’s knowledge. It’s not only a return of her worst symptoms that she worries about. “If another medicine were substituted without telling me or my doctor, it could put my pregnancy at risk,” she said.

Fears like Crow’s have helped propel legislative attempts in many states this year to make sure that patients and doctors are notified whenever imitations deemed “interchangeable” by the US Food and Drug Administration (FDA) are substituted for brand-name biologics.

biosimilars

 

Already, Colorado has passed a notification law, and Utah has revised its earlier law. More than a dozen states are considering comparable measures.

Notification bills began popping up in states two years ago, but most were defeated in the face of opposition from manufacturers of biologic copies, which are called biosimilars, and from organizations representing pharmacists, who objected to the extra workload notification requirements might entail.  Continue reading

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No evidence Ebola in West Africa is becoming more deadly, study

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Ebola virusFrom the National Institutes of Health

The Ebola virus circulating in humans in West Africa is undergoing relatively few mutations, none of which suggest that it is becoming more severe or transmissible, according to a National Institutes of Health study in the journal Science.

The study compares virus sequencing data from samples taken from patients in Guinea (March 2014), Sierra Leone (June 2014) and Mali (November 2014).

Ebola virus, isolated in November 2014 from patient blood samples obtained in Mali. The virus was isolated on Vero cells in a BSL-4 suite at Rocky Mountain Laboratories.

“The Ebola virus in the ongoing West African outbreak appears to be stable—that is, it does not appear to be mutating more rapidly than viruses in previous Ebola outbreaks, and that is reassuring,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. “We look forward to additional information to validate this finding, because understanding and tracking Ebola virus evolution are critical to ensuring that our scientific and public health response keeps pace.” Continue reading

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States reluctant to regulate fertility services

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IVF egg thumbBy Michael Ollove
KHN

The Utah legislature took a step last week into territory where state lawmakers rarely tread.

It passed a law giving children conceived via sperm donation access to the medical histories of their biological fathers. The law itself stirred no controversy. The oddity was that the legislature ventured into the area of “assisted reproduction” at all.

Assisted reproductive technology (ART) helps infertile couples to conceive. Compared to many other industrialized nations, neither the U.S. nor state governments do much to oversee the multibillion-dollar industry.

“The United States is the Wild West of the fertility industry.”

“The United States is the Wild West of the fertility industry,” Marcy Darnovsky, executive director of the Center for Genetics and Society said, echoing a description used by many critics of the regulatory environment surrounding ART. Continue reading

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Do you really need counseling on your Alzheimer’s gene test?

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From WBUR’s CommonHealth:

A new Brigham and Women’s Hospital study finds that we may not need quite as much genetic counseling as we’d thought. Particularly on relatively cut-and-dried findings, like test results on a common gene that raises the risk of Alzheimer’s disease. Listen to WBUR host Anthony Brooks speak with Dr. Robert C. Green:

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Many insurers do not cover drugs approved weight-loss drugs

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ScaleBy Michelle Andrews
KNH

In December, the Food and Drug Administration approved a new anti-obesity drug, Saxenda, the fourth prescription drug the agency has given the green light to fight obesity since 2012.

But even though two-thirds of adults are overweight or obese — and many may need help sticking to New Year’s weight-loss resolutions — there’s a good chance their insurer won’t cover Saxenda or other anti-obesity drugs.

The health benefits of using anti-obesity drugs to lose weight—improvements in blood sugar and risk factors for heart disease, among other things—may not be immediately apparent.

“For things that are preventive in the long term, it makes plan sponsors think about their strategy,” says Dr. Steve Miller, the chief medical officer at Express Scripts, which manages the prescription drug benefits for thousands of companies. Companies with high turnover, for example, are less likely to cover the drugs, he says.

“Most health plans will cover things that have an immediate impact in that plan year,” Miller says.

Miller estimates that about a third of companies don’t cover anti-obesity drugs at all, a third cover all FDA-approved weight-loss drugs, and a third cover approved drugs, but with restrictions to limit their use. The Medicare prescription drug program specifically excludes coverage of anti-obesity drugs.

Part of the reluctance by Medicare and private insurers to cover weight-loss drugs stems from serious safety problems with diet drugs in the past, including the withdrawal in 1997 of fenfluramine, part of the fen-phen diet drug combination that was found to damage heart valves. Continue reading

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US provides immunity to Ebola vaccine developers

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 Secretary of Health & Human Services Sylvia Mathews BurwellHealth and Human Services Secretary Sylvia M. Burwell today announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to facilitate the development and availability of experimental Ebola vaccines.

This declaration is intended to assist in the global community’s effort to help combat the current epidemic in West Africa and help prevent future outbreaks there, the HHS said.

The declaration provides immunity under United States law against legal claims related to the manufacturing, testing, development, distribution, and administration of three vaccines for Ebola virus disease. It does not, generally, provide immunity for a claim brought in a court outside the United States.

Past declarations have covered vaccines used in H5N1 pandemic influenza clinical trials in 2008, products related to the H1N1 influenza pandemic in 2009, and the development and manufacturing of antitoxins to treat botulism in 2008.

Here are more details about the action from the HHS release:

Continue reading

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