Category Archives: Biotechnology

There’s a life-saving hepatitis C drug. But you may not be able to afford it.

Share

Sovaldi logoBy Julie Appleby
KHN Staff Writer

MAR 03, 2014

This KHN story was produced in collaboration with 

There’s a new drug regimen being touted as a potential cure for a dangerous liver virus that causes hepatitis C.  But it costs $84,000 – or $1,000 a pill.

And that price tag is prompting outrage from some consumers and a scramble by insurers to figure out which patients should get the drug —and who pays for it.

Called Sovaldi, the drug is made by California-based Gilead Sciences Inc. and is the latest in handful of new treatments for hepatitis C, a chronic infection that afflicts at least 3 million Americans and is a leading cause of liver failure. It was approved by the U.S. Food & Drug Administration in December. Continue reading

Share

Science on Stage: Staged readings of “The Sequence” by Seattle playwright Paul Mullin

Share

dna

Northwest Association for Biomedical Research and Seattle Public Theater will present ‘Science on Stage’ – staged readings with the director and cast of Seattle playwright Paul Mullin’s play ‘The Sequence.’

Bathhouse Theater at Green Lake with pre- or post-play discussions

Oct. 5 -   Saturday,   2pm          post-play discussion for NWABR members    - 3:45pm

Oct. 12 – Saturday,   2pm           post-play discussion for the public                   – 3:45pm

Oct. 13 - Sunday,     7pm           pre-play discussion for NWABR donors           – 6:00pm

Tickets:  $20 for NWABR members, $22 for all others, available online or at the door.

Play Synopsis:  Sequencing of the human genome was a public race – and a personal war!  Strong personalities, emerging technology and differing views on public vs. private DNA ownership fueled the race to obtain the first human DNA sequence.  Covering the story was a young journalist worried about her own destiny with breast cancer and the information that her genome sequence would uncover.

More information and online ticket information are available at http://nwabr.org/science-on-stage or contact Reitha Weeks at rweeks@nwabr.org for information about group sales.

Proceeds support NWABR programs.

Share
Tablet Thumb Blue

FDA moves to reduce use of long-acting opioid pain drugs

Share

The US Food and Drug Administration has changed the labeling on long-acting opioids, such as OxyContin, in an effort to limit the use of these drugs to patients with severe refractory pain. Here’s is the Consumer Update from the FDA released today.

FDA Consumer Update

FDA logojpgConsumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.

In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.

“The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use,” says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA’s Center for Drug Evaluation and Research.

“Altogether, the actions we’re now announcing are part of FDA’s efforts to make opioids as safe as possible for those who need them,” Throckmorton adds.

He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.

How Labeling Will Change

Opioids work by changing the way the brain perceives pain. They are available by prescription as pills, liquids, and skin patches.

Extended-release and long-acting (ER/LA) forms pose a greater safety concern because—as their names suggest—they produce their effects for a longer period, and many contain higher doses compared with immediate release or opioid/non-opioid combination products.

They include, to name a few, long acting versions of opioids such as morphine, oxycodone, and fentanyl.

Currently, labeling on these ER/LA opioids indicate they are for “the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”

However, the updated indication for when to prescribe and take these medicines will, when finalized, emphasize that other, less potentially addictive, treatment options should be considered first.

FDA is requiring labeling that says the drugs are “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

The “limitations of use” portion of the new labeling retains language indicating that the drugs are not intended for use as an “as-needed” pain reliever.

Furthermore, the new labeling adds: “Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

This new labeling language emphasizes that patients in pain should be assessed not only by their rating on a pain intensity scale, but also based on a more thoughtful determination that their pain—however it may be defined—is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.

This framework better enables prescribers to make decisions based on a patient’s individual needs, given the serious risks associated with ER/LA opioids, against a backdrop of alternatives such as immediate release (IR) opioids and non-opioid pain relievers.

It allows prescribers to make an assessment of pain relative to a patient’s ability to perform daily activities or enjoy a reasonable quality of life.

FDA-approved labeling of these pain relievers already describes the effects on newborns of exposure to these drugs while in the mother’s womb and warns against use by women during pregnancy and labor and while nursing.

The new labeling, however, will provide more detail and will elevate the risk of neonatal opioid withdrawal syndrome (NOWS) to the most prominent position in labeling—a boxed warning. Symptoms of NOWS may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

Postmarket Studies

Recognizing the need for more scientific data about the benefits and risks of ER/LA opioids when used over long periods, FDA also decided to require drug companies to conduct longer term studies and trials of ER/LA opioid pain relievers on the market.

The companies must evaluate long-term use, with the goal of assessing a variety of known serious risks, including misuse, abuse, addiction, overdose, and death, as well as the risks of developing increasing sensitivity to pain.

Education to Reduce Risk

Following implementation of the safety labeling changes, certain educational materials for patients and health care professionals will be modified to reflect the new labeling for the ER/LA opioid pain relievers.

As part of the new labeling changes, opioid manufacturers also must revise a paper handout patients receive with their prescription.

The ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) will also be updated after the labeling changes are finalized.

The ER/LA Opioid Analgesics REMS requires manufacturers to make available continuing education courses for health care professionals who prescribe these drugs.

The courses, from accredited sources, teach about risks and safe prescribing and safe use practices of these medications.

“By improving information about the risks of ER/LA opioid pain relievers and by clarifying the populations for whom the benefits outweigh the risks, we aim to improve the safe and appropriate use of these products,” says Throckmorton.

He adds: “This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Sept 10, 2013

Share

Drug companies battle against generic biologics state-by-state.

Share

By Michael Ollove
Stateline Staff Writer

The year 2013 began with the promise of a state-by-state, coast-to-coast battle between the makers of brand-name medications derived from living organisms—known as biologics—and those who to make and sell copies of those drugs.

The battle has turned into a rout, at least for now. In state after state, the brand-name makers—led by the pharmaceutical giants Amgen and Genentech—have been unable to convince state legislatures to require pharmacists to notify doctors (and sometimes patients) when they substitute generics for brand-name biologic drugs.

Manufacturers of copies fiercely opposed such a requirement, which they said would put them at a competitive disadvantage.

Notification measures died in Arizona, Arkansas, Colorado, Indiana, Illinois, Maryland, Mississippi, Nevada, Texas and Washington.

pills-spill-out-of-bottle

Oregon, Utah and Virginia all adopted notification requirements, but with sunsetting provisions that will take effect before any of the knock-offs reach the market. Only one state, North Dakota, passed the measure the brand-name manufacturers sought.

“State legislators accepted that there was absolutely no need to push this type of legislation” said Brynna Clark, director of state affairs for the Generic Pharmaceutical Association, which took the lead in organizing the effort against notification requirements. “Nobody’s hair was on fire.”

Measures are still alive in California, where the prospects for passage look bright, and in Pennsylvania and Massachusetts.

Two Years Away

Most believe it will be at least two years before any copies of biologics receive approval from the Food and Drug Administration (FDA). But the skirmishes in 18 states this year give a sense of the high stakes involved.

Biologics already account for roughly a quarter of the $320 billion spent annually on medications in the U.S., according to IMS Health, and biologic medicines are expected to command ever larger portions of the prescription drug marketplace.

The Congressional Budget Office has estimated that substituting biologic doppelgangers for brand names would reduce federal Medicaid and Medicare spending by $25 billion over 10 years.

The CBO estimates that total federal spending on prescription drugs during the same period will total $500 billion.

The Affordable Care Act calls for an abbreviated approval process for the biologic copies, as a means to promote competition and reduce costs.

While the federal government will determine whether particular biosimilars are interchangeable with the originals, it will be up to the states to determine the exact policies regarding substitutions.

Companies that make the copies say their products should be treated no differently than generic chemical drugs. By state law, pharmacists can (and in some cases, must) substitute cheaper generics for brand-name medications once the original patent has expired, unless otherwise directed by the doctor or, in some states, the patient.

Complex Substances

But, there are big differences between copying chemical drugs and copying biologic drugs.

Until the 1970s, virtually all manufactured medicines were derived from chemicals. They are sometimes called “small molecule” drugs because they are composed of relatively few atoms and have stable, well-defined chemical structures, making it relatively easy to produce exact duplicates.

Biologics, which are used to treat patients with cancer, blood irregularities, psoriasis, and auto-immune and neurological disorders, are the result of complicated biological manufacturing and testing processes. They have as many as 20,000 atoms, and they interact with the body in different ways from chemically-derived medicines.

As a result, it is virtually impossible to make exact copies, but only something very similar. Hence, the generic versions are often referred to as “biosimilars,” “bioequivalences” “biocomparables,” “me-too biologics” or “biobetters.”

The expense and complexity of manufacturing biosimilars also means they won’t be as deeply discounted as generic chemical drugs, which generally cost 50 percent to 90 percent less than the originals. Biologic copies are expected to cost between 10 percent and 20 percent less than the originals.

Although biosimilars are already on the market in Europe, none have yet been approved for the U.S. market (U.S. original patent periods are longer). The FDA has, however, issued draft rules for the approval process. Most expect the first biosimilars to gain FDA approval in 2015.

Notification of Substitutes

But battle lines have already been drawn. Amgen, which makes both biologics and biosimilars, and Genentech have led the efforts to promote passage of state notification laws. Together the two companies contributed about $650,000 to state legislative races in 2012.

Gino Grampp, director of research and development policy for Amgen, said that because biosimilars are not identical to the originals, it is important that physicians be alerted when there is a substitution.

Otherwise, if a patient has an adverse reaction to a biosimilar, the doctor may not be able to identify the cause of the problem.

“We aren’t saying the substitution shouldn’t be made,” Grampp said. “We’re saying the doctor should have a record of that substitution.”

State Sen. Jerry Hill, the Democrat who sponsored the notification bill in California, was persuaded by that argument. “In California, there’s real sensitivity to the patient’s right to know and patients controlling their own bodies,” Hill said.

But the generic association argues the proposed legislation is a ruse by the brand-name manufacturers to cause anxiety about biosimilars.

“It’s going to raise trust issues and concerns about these medicines,” said Clark of the Generic Pharmaceutical Association. “Why does my doctor have to be specially notified if these drugs are really OK?”

Clark argues that if the FDA approves a biosimilar as interchangeable with the original product, there is no need to create obstacles at the state level. Biosimilars, she argues, should be treated no differently from generic chemical drugs.

Level of Acceptance

Few doctors object to the substitution of generics for chemical medications, but “there’s a real question whether there will be the same level of acceptance among doctors of biosimilars as there are with generics,” said Jack Hoadley, a research  professor at the Health Policy Institute at Georgetown University.

Any signal, such as a notification requirement, that suggests biosimilars are not the equal of the originals could diminish confidence in them among doctors and patients.

Meanwhile, the Generic Pharmaceutical Association has found a potent ally in pharmacists, who fear the notification requirement would be a burden. Their opposition was instrumental in the defeat of Maryland state Sen. Joan Carter Conway’s notification bill this year.

“They said it was just too much work,” said Conway, a Democrat.

Stateline logo

Stateline is a nonpartisan, nonprofit news service of the Pew Center on the States that provides daily reporting and analysis on trends in state policy.

Share
Thumbnail

FDA warns of rare acetaminophen risk

Share

A Consumer Update from the US Food and Drug Administration

ucm363013Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).

Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin.

If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.

Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription medicines.

Tylenol is one brand name of the pain reliever sold over the counter, but acetaminophen is also available as a generic under various names.

It is also used in combination with other medicines, including opioids for pain and medicines to treat colds, coughs, allergy, headaches and trouble sleeping.

“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction. “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”

Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions.

Advil and Motrin are among the common brand names that include ibuprofen as an active ingredient. Aleve and Midol Extended Relief are among the best-known brand names that include naproxen as an active ingredient.

FDA is requiring that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen.

FDA will work with manufacturers to get the warnings added to the labels of over-the-counter (OTC) medicines containing acetaminophen.

On OTC medicines, the word “acetaminophen” appears on the front of the package and on the Drug Facts label’s “active ingredients” section.

On prescription medications, the label may spell out the ingredient or use a shortened version such as “APAP,” “acet,” “acetamin” or “acetaminoph.”

Ingredient Linked to Several Conditions

Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are the two most serious skin reactions linked in rare cases to acetaminophen. They usually require hospitalization and can cause death.

Problems usually begin with flu-like symptoms followed by rash, blistering and extensive damage to the surfaces of the skin. Recovery can take weeks or months, and possible complications include scarring, changes in skin pigmentation, blindness and damage to internal organs.

A third skin reaction, acute generalized exanthematous pustulosis (AGEP), usually resolves within two weeks of stopping the medication that caused the problem.

A serious skin reaction can occur at any time, even if you’ve taken acetaminophen previously without a problem. There is currently no way of predicting who might be at higher risk.

If you’ve ever had a skin reaction when taking acetaminophen, don’t take the drug again and discuss alternate pain relievers/fever reducers with your health care professional.

Evidence of Link

Prior to deciding to add a warning about skin reactions to products containing acetaminophen, FDA reviewed medical literature and its own database, the FDA Adverse Event Reporting System (FAERS).

A search of FAERS uncovered 107 cases from 1969 to 2012, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen.

A small number of cases, just over two dozen, are documented in medical literature, with cases involving people of various ages.

FDA has examined—and continues to examine—acetaminophen for safety issues, just as it does with all approved drugs. The warning comes two years after FDA took new steps to reduce the risk of liver injury from acetaminophen.

In that case, FDA asked all makers of prescription products to limit acetaminophen to 325 milligrams per tablet or capsule. FDA also required all prescription acetaminophen products to include a Boxed Warning—FDA’s strongest warning, used for calling attention to serious risks.

The agency continues to consider the benefits of this medication to outweigh the risks.

“FDA’s actions should be viewed within the context of the millions who, over generations, have benefited from acetaminophen,” says Hertz. “Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

August 1, 2013

Share
Fitness pal thumbnail

Use of health and fitness apps explodes – but which ones work?

Share

Fitness palBy Martha Bebinger, WBUR

Christine Porter is hooked on the My Fitness Pal app. In October, after deciding to lose 50 pounds, Porter started typing in everything she eats, drinks and any exercise she gets.

“This is like my main page here,” says Porter, who lost 42 pounds in nine months. “It’s telling me I have about 1,200 calories remaining for the day. When I want to record something I just click the ‘add to diary’ button. I’m on it all day either through my phone or through the computer.”

Health apps such as My Fitness Pal are turning smartphones and tablets into exercise aides, blood pressure monitors and devices that transmit an EKG.

And the day is not far off when doctors may be suggesting apps along with prescribing drugs to help patients manage their health. But the explosion of apps is way ahead of tests to determine which ones work.

Porter heard about the app from Ryan Sherman, her health coach at a clinic for employees of Massachusetts General Hospital. Sherman helps clients turn a doctor’s orders into a user friendly action plan for keeping high blood pressure or sugar levels in check.

Increasingly, says Sherman, patients with diabetes or heart problems are coming in, pulling out their phones, and saying hey, have you seen this app?

“There’s a new one every day, so it’s trying to keep up with that,” Sherman says.

Which is one reason why many doctors are suggesting, but not prescribing apps. Doctors aren’t sure which of the roughly 40,000 available apps do what they claim to do.

The U.S. Food and Drug Administration divides health apps into two categories: those that help with healthy lifestyles and those that turn your phone into a medical device to, say, record blood pressure or an EKG, and then send those readings to a doctor.

The FDA is revising regulations for apps in the medical device category. It does not plan to regulate diet or exercise apps. A few private companies are stepping in to do that task. Ben Chodor started Happtique, a company that reviews apps and gives those are at least perform correctly, a seal of approval.

“It’s the Wild West and someone needs to come in and at least help the consumers and the clinicians and the payers sort through the 40,000-plus apps that are already out there,” says Chodor.

Happtique will not say which apps work better than others or guarantee their safety. Still, some doctors say apps that work are transforming medicine.

Dr. Eric Topol, the chief academic officer at Scripps Health in San Diego, says apps that monitor blood pressure or glucose rates can be more valuable than prescriptions to keep these conditions in check.

“When we use a medication we don’t know if it’s going to work or not.  It’s much better when a person’s taking their blood pressure on a frequent basis,” says Topol.

Some apps work with another device, such as when a person wears a blood pressure monitor tha transmits the data to the person’s phone. “The average person looks at their smart phone 150 times a day,” says Topol. “All of a sudden, they’re able to diagnose if their blood pressure’s adequately controlled and what are the circumstances when it’s not.”

Topol says apps that control blood pressure will help prevent strokes and heart attacks and may mean doctors should prescribe phones and tablets in addition to apps. But Dr. Laura Ferris at the University of Pittsburgh, urges patients to use apps cautiously.

“It does make sense that people who download these apps and use them really understand that they are doing so at their own risk,” says Ferris.

Ferris ran a study of apps that claim to detect cancer based on a picture of a mole. Only one of the apps sends the  picture of your suspicious mole to a dermatologist. It was right 98 percent of the time.

Three others, says Ferris, could be dangerously wrong: “The best of them missed melanoma 30 percent of the time. The worst of them missed melanoma over 90 percent of the time.”

Despite the growing interest in medical apps, there are many unresolved questions about their use: Should all the information patients collect become part of their medical record and how? Who in the doctor’s office analyzes patients’ numbers? Will insurers cover the cost of apps?

Dr. Ben Crocker, at the Mass General clinic that is testing a few apps, says those are questions doctors will have to answer.

“This is what’s engaging patients,” says Crocker. “Patients are coming to their doc for the first time saying, ‘I’ve been collecting some information or I’ve been using this application.’  And that, I think we can’t ignore no matter where this is taking us, no matter how Wild West it feels.”

This story is part of a partnership that includes WBURNPR, and Kaiser Health News.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Share
Robot Thumbnail

Robotics for the paralyzed

Share

NIH Medline Plus magazine feature

Latest Advances Help People Regain Function and Independence

Founded in 2000, the National Institute for Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health (NIH), works to speed discovery and development of biomedical technologies in every field of medicine by bringing together teams of scientists and engineers from many different backgrounds to spark innovative approaches to health care.

The technologies have the potential to greatly advance the lives of persons with paralysis, as well as amputation and numerous neuromuscular disorders, such as Parkinson’s disease and others.

New Technologies—Years of NIH investment have made the field of neural prosthetics and other technologies to assist paralyzed individuals possible.

Improved Quality of Life—Neural prosthetic systems have advanced to allow the severely paralyzed to achieve independent control of function and engage in activities of daily living to improve their quality of life.

Options for the Paralyzed—The expanding options for paralyzed individuals include:

  • robotic arms
  • spinal cord stimulation
  • improved prosthetic limbs
  • restored ability to communicate

Shortly after pitching his Oregon State University baseball team to the 2006 College World Series championship, Rob Summers was struck and paralyzed from the chest down by a hit-and-run driver.

But now, thanks to an experimental mix of physical therapy and electrical stimulation of the spinal cord, he can do something he never dreamed of doing again: stand and voluntarily make some leg movements.

“It was completely unexpected,” says V. Reggie Edgerton, professor of integrative biology and physiology, and neurobiology at the University of California, Los Angeles. Until Summers, scientists believed that patients with a completely severed spinal cord would never be able to regain voluntary control of their paralyzed limbs.

To see if spinal cord stimulation could be successful in people, Edgerton and his collaborator, Dr. Susan Harkema at the University of Louisville, implanted an electrode array normally used to treat back pain in Summers’ lower back.

Harkema led the clinical study, which was supported by the National Institute of Biomedical Imaging and Bioengineering, the National Institute of Neurological Disorders and Stroke, and the Christopher and Dana Reeve Foundation.

After years of being bound to his wheelchair, Summers can now push himself up and remain standing for a few minutes while receiving stimulation. With the support of a harness and help from therapists, he also can make stepping motions on the treadmill. Other functions impaired by his injury have improved, too: body temperature regulation, bladder and bowel control, and sexual function.

Edgerton thinks connections between Summers’ brain and the part of the spinal cord below the point of his injury may have been spared, or that the therapy encouraged nerve cells to make new connections.

Imagine Cathy Hutchinson’s satisfaction!

For the first time since being paralyzed from the neck down by a stroke fifteen years ago, she was able to reach for and drink coffee on her own—using her thoughts alone to direct a robotic arm to her lips.

The feat was made possible by Cathy’s fierce determination and a device called the BrainGate2 neural interface system, designed to put robotic arms and other assistive devices under the brain’s control.

The BrainGate consists of a baby aspirin-sized sensor that is implanted into the motor cortex (the part of the brain that directs movement) to monitor brain signals.

It is attached to computer software and hardware that then turn the signals into commands for moving external devices, such as Hutchinson’s robotic arm.

“The smile on her face was remarkable,” said Leigh Hochberg, M.D., Ph.D., an associate professor of engineering at Brown University in Providence, R.I. and a critical care neurologist at Massachusetts General Hospital (MGH)/Harvard Medical School in Boston, who led the clinical study of BrainGate. Although the technology is years away from practical use, he noted it is making good progress.

“This is another big jump,” said John Donoghue, Ph.D., who leads the development of BrainGate technology and is the director of the Institute for Brain Science at Brown University. “We’re getting closer to restoring some level of everyday function to people with limb paralysis.”

“That it is possible for a person to mentally control a robotic limb in three-dimensional space represents a remarkable advance,” noted Roderic Pettigrew, M.D., Ph.D., director of NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB), which supports the research. The ultimate goal is to reconnect the brain directly to paralyzed limbs rather than robotic ones, according to researchers.

To Find Out More

NIH Medline Plus magazine NIH MedlinePlus is produced by NIH, the National Library of Medicine, and the Friends of the National Library of Medicine.

 

 

Share

Had a bad reaction to a prescription drug? FDA wants to hear about it.

Share

WANTED: Consumers to Report Problems

An FDA Consumer Update

Blue and white capsules spilling out of a pill bottle

new consumer-friendly form is now available for making reports to MedWatch, the Food and Drug Administration’s (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products.

The less technical form is part of a larger effort to encourage consumers to submit quality reports.

By reporting your experience or suspicion of a product problem to MedWatch, you could help identify an unknown risk and potentially spark a variety of actions—from changes to a warning label to removal of the product from the market.

Use MedWatch to report issues with:

  • Prescription and over-the-counter drugs
  • Nutrition products, including infant formulas, dietary supplements, herbal remedies
  • Cosmetics
  • Medical devices, from contacts and breast implants to test kits and pacemakers
  • Biologics, such as human cells and tissues for transplantation and medicines made from living matter
  • Food (including beverages and ingredients added to foods)

Consumers have been welcome to report side effects, product quality problems and other issues to MedWatch since the program was founded in 1993, although the focus had always been more on encouraging reporting from health care professionals.

But as more and more consumers visit online sites to research their conditions and understand their care, opportunities for increasing their participation in MedWatch became clear. FDA asked consumer groups to help promote the website and the MedWatch reporting form to their members.

“Their initial response was that the reporting form was too technical, and they suggested a more consumer-friendly version,” said Beth Fritsch, R.Ph., MBA, deputy director of FDA’s Office of Health and Constituent Affairs.

Working with groups such as AARP, Consumers Union and the National Partnership for Women and Families, FDA created a new form and published it for public comment in the Federal Register. Those comments were also considered, further revisions were made, and the less technical form is now available at MedWatch.

To spread awareness of the reporting mechanism, FDA is using social media, including Twitter, email lists and electronic newsletters. It is also getting help in this effort from librarians, consumer organizations, patient advocacy groups, health professional organizations and schools of medicine, pharmacy and nursing.

Additionally, MedWatchLearn, a new web-based learning tool, will be used to teach students in medical, pharmacy and nursing schools to fill out MedWatch reports and encourage others to do so.

How Your Reports Could Help

Even though consumers have been less likely than health care professionals to report problems to MedWatch, their cooperation to date has already been beneficial. For example, consumer reports to MedWatch led to a nationwide recall of a particular lot of pre-filled syringes.

Consumer reports also alerted FDA to an unusual issue: Men using a testosterone gel on their upper arms and shoulders were inadvertently exposing, and harming, children. The reports led to stronger product warning labels to alert the public and urge that the gel be covered after application so it wouldn’t get on other people.

“MedWatch is one of the lines of defense against products that are contaminated or that pose risks that weren’t previously known,” said Anna Fine, Pharm.D., director of FDA’s Health Professional Liaison Program. “Greater consumer involvement will mean we have more eyes and ears available to catch problems before they escalate.”

MedWatch reports sometimes provide the first clue that an issue needs investigation and possible action. In other cases, a clinician or researcher inside or outside FDA might first suspect a link between a problem and a drug or other product, and MedWatch becomes a useful database that FDA experts can search for additional clues.

Consumers can play a particularly critical role by reporting unexpected, serious side effects from medicines given to children. Most clinical trials for children’s medicines involve a relatively small number of patients, and problems might not be detected until medicines have been used by a large number of children of different ages.

How To Report

Consumers can continue to ask their health care professional to file a MedWatch report or to report a suspected problem directly to a drug manufacturer.

By law, companies are required to report to FDA certain serious problems that may have been caused by their products, including in cases where consumers report suspected problems to the company. Currently, the vast majority of more than 900,000 MedWatch reports a year are funneled to FDA through companies.

However, consumers who decide to report a problem directly to FDA themselves will find that the new form is now easier and quicker to fill out.

“There is a delicate balance between asking for useful, scientific data and encouraging participation by making the form accessible to consumers,” said Fritsch. “We’ve made a great effort to find that balance.”

Consumers are not expected to provide proof that the problem was caused by the particular product. And Fritsch adds that consumers should send the report even if they don’t have all the information requested. Questions are answered at MedWatch’s toll-free line, 1-800-332-1088, between 8 a.m. and 4:30 p.m. ET.

MedWatch forms for both consumers and health care professionals must be faxed or mailed. Online submission capability will be available in coming months.

Fritsch, who noted that MedWatch is marking its 20th anniversary, concluded: “Every report counts.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Photo courtesy of Pawel Kryj

June 3, 2013

Share

Accuracy of blood glucose meters draws scrutiny

Share

Glucometer showing a blood sugar of 105By Phil Galewitz

Blood glucose meters, which millions of diabetics rely upon to regulate their blood sugar, have become less costly and easier and less painful to use.

But they haven’t become more accurate, a top Food and Drug Administration official said Tuesday at a meeting of researchers analyzing studies that show wide variation in the performance of the machines used to measure blood glucose levels.

Katherine Serrano, diabetes branch chief in the FDA division of chemistry and toxicology devices, said the federal government was aware of problems with meters on the market. But she said the FDA is limited in its response because some manufacturers are in Asia, and the agency must rely on the manufacturers’ own studies related to accuracy.

Health experts say if a blood glucose meter provides a false reading, it puts a patient at risk of dosing with too much or too little insulin. If too much insulin is given, it can bring blood glucose levels down to dangerously low levels, putting the patient at risk of severe hypoglycemia and possible hospitalization.

Typically, a person with diabetes tests his or her blood sugar before eating or exercising to find out if he or she is within normal range. The patient then uses insulin or diet to restore blood glucose to a healthy level. About 24 million people have diabetes in the Unted States,  and nearly a third of that number rely on insulin to regulate their blood sugar.

Researchers at the Diabetes Technology Society meeting in Arlington, Va., presented several studies done in the United States and Germany showing it is common for many devices to fall short of the 95 percent accuracy standard required by the FDA.

Consumers often buy the devices based on which is cheapest, or which is covered by their insurance policy without realizing that not all meters offer same accuracy, they said.

Serrano said several factors can reduce a meter’s accuracy, such as storing it in a hot or cold area, or failing to wash your hands before using them. She said studies done by manufacturers seeking approval are done in labs by trained personnel.

“There have been a lot of advances in the technology of the meters but we have not seen great strides in accuracy,” Serrano said.

She noted manufacturers don’t have much incentive to improve accuracy because federal law requires  only that they prove they are “substantially equivalent” to another meter already on the market.

The FDA relies on the manufacturer’s own studies to analyze accuracy and does not require any independent testing, she said. Here are some tips to help improve accuracy.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Share

Targeting prescribers can reduce excessive use of antibiotics in hospitals

Share

Three red and white capsules

Giving prescribers access to education and advice or imposing restrictions on use can curb overuse or inappropriate use of antibiotics in hospitals, according to a new Cochrane systematic review.

This is important because unnecessary use of these life-saving drugs is a key source of antibiotic resistance in bacteria.

Some infections are no longer treatable due to bacterial resistance. Compared to infections caused by treatable bacteria, those caused by multidrug-resistant bacteria lead to more deaths, longer hospital stays and increased healthcare costs. Reducing inappropriate use of antibiotics should help to slow the spread of resistant bacteria.

Achieving this is proving difficult as by most estimates, antibiotic use in hospitals is rising, with some evidence suggesting more than a third of prescriptions are inappropriate.

The review, published in The Cochrane Library, included 89 studies from 19 countries, with most studies aiming to decrease excessive antibiotic use.

The researchers analysed data from two types of studies. In persuasive studies, doctors were given advice and feedback about prescribing antibiotics. In restrictive studies, restrictions were placed on prescribing, for example, doctors might be required to seek approval from a specialist.

Overall, prescribing in hospitals improved and data from 21 studies showed that hospital infections decreased.

“Our review shows that a wide variety of different interventions have been successful in changing antibiotic prescription in hospitals,” said lead researcher Peter Davey, who is based at the Population Health Sciences Division at the University of Dundee in Dundee, UK. “However, we need more studies that explore how these changes benefit patients and how they impact on healthcare costs.”

Restrictive methods yielded greater improvements in prescription, although no studies undertook direct comparisons between restrictive and persuasive methods.

“The fact that restrictive methods work well is important because it supports restriction of antibiotic use when the need is urgent, such as in an outbreak situation,” said Davey. “However, the evidence base would be enormously enhanced by direct comparisons with persuasive methods.”

Full citation: Davey P, Brown E, Charani E, Fenelon L, Gould IM, Holmes A, Ramsay CR, Wiffen PJ, Wilcox M. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD003543. DOI: 10.1002/14651858.CD003543.pub3.

URL Upon publication: http://doi.wiley.com/10.1002/14651858.CD003543.pub3

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

Share

Cloning, stem cells long mired In legislative gridlock

Share

IVF egg thumbBy Julie Rovner, NPR News

This story comes from our partner ‘s Shots blog.

The news that U.S. scientists have successfully cloned a human embryo seems almost certain to rekindle a political fight that has raged, on and off, since the announcement of the creation of Dolly the sheep in 1997.

“The issue of legislation on human cloning is about to get hot again,” says Hank Greely, director of the Center for Law and the Biosciences at Stanford Law School.

But it’s a fight that has, over the past decade and a half, produced a lot of heat and light and not a lot of policy.

Human cloning

In fact, for all the arguing about the issue that’s happened in Washington over the years, human cloning is still technically legal, at least in much of the country.

“There are already 60 countries in the world that have laws on their books banning human reproductive cloning, and this prohibition is also in a number of international agreements” says Marcy Darnovsky, executive director of the Center for Genetics and Society, which is devoted to the responsible use of new genetic and reproductive technologies. “But in the U.S., we have not managed to put such a law on the books at the federal level.”

At least 15 states ban cloning, either for reproductive purposes or research or, in come cases, both, according to the National Conference of State Legislatures.

But Congress has mostly fought issues of both stem cell research and cloning to a draw.

“What we saw the last time cloning was in the headlines was that the discussion really got mired in the abortion controversy,” Darnovsky said.

The House passed bills banning all forms of cloning in 2001 and 2003; the Senate failed to act in both cases.

“All the other issues got completely swamped,” she said. “And I really hope that doesn’t happen this time.”

But both the issues of cloning — for research and reproduction — and embryonic stem cell research have been mired in the abortion controversy from the start.

Stem Cell Research

About the only law that has been able to pass is language that gets added to the funding bill for the Department of Health and Human Services every year since the mid-1990s — the so-called Dickey-Wicker Amendment, named for its original House sponsors, Reps. Jay Dickey, R-Ark., and Roger Wicker, R-Miss. It bars the use of federal funds for research that could destroy or harm a human embryo.

The Clinton administration decided that federal funding of embryonic stem cell research using cell lines derived from embryos destroyed with private funds did not violate that law.

President Bush put that policy into force but severely limited the cell lines available to researchers.

“I have concluded that we should allow federal funds to be used for research on these existing stem cell lines, where the life-and-death decision has already been made,” he said in a televised address to the nation.

Meanwhile, over the years Congress debated several bills to expand federal funding of embryonic stem cell research, under specific ethical guidelines, as well as legislation to ban cloning intended to make a baby. None, however, was able to pass both the House and Senate and get the president’s signature.

When he came into office in 2009, President Obama used his executive authority to expand federal funding for embryonic stem cell research, while maintaining guidelines such as not paying women for their eggs.

“The majority of Americans, from across the political spectrum, and from all backgrounds and beliefs, have come to a consensus that we should pursue this research,” he said.

FDA Rules

But Congress remains deadlocked over the bioethical issues — which is not to say that there is no federal regulation.

Jonathan Moreno, a bioethicist at the University of Pennsylvania, points out that the Food and Drug Administration has, from the start, said it would closely regulate anything it deemed to be human cloning, whether reproductive or therapeutic.

“Once you start talking about putting many of the products of these cells into people, then you get into an area where the FDA is very interested,” he said.

Meanwhile, Darnovsky of the Center on Genetics and Society says she hopes this new development might break the legislative logjam.

“This development, if it turns out to be replicable, will mean that there will be cloned human embryos in labs around the country,” she said. “And we really need to make sure that no unscrupulous person would ever try to use those to produce a cloned human being.”

Congress, however, has been unable to pass much of anything this year. It’s unclear yet if this will rise to the level of must-pass.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Share
Alert Icon with Exclamation Point!

FDA warns pregnant women to not use certain migraine prevention medicines

Share

Alert Icon with Exclamation Point!From the FDA

Valproate products can lower IQ scores in children of mothers who used them during pregnancy

The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy.

Therefore, these drugs should never be used by pregnant women for the prevention of migraine headaches.

Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.

Valproate products have several FDA-approved uses including: prevention of migraine headaches; treatment of epilepsy (seizures); and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder)

.Medicines that contain valproate already have a boxed warning for fetal risk, including birth defects.

The recently published Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study found further evidence of the IQ risk, leading to today’s strengthened warnings.

“Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

For its other approved uses — bipolar disorder and seizures — valproate may have some value in pregnant women, but it should only be taken if other medications have not controlled the symptoms or are otherwise unacceptable.

Women who can become pregnant should not use valproate unless it is essential to managing their medical condition.

Women who are pregnant, or who become pregnant while taking one of these medications, should talk to their health care professional immediately

Women should not stop taking their medication without talking to their health care professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the developing fetus.

Women of childbearing age taking valproate products should use effective birth control.

It is not known if there is a certain time period during pregnancy when valproate exposure can result in decreased IQ. The women in the NEAD study were exposed to antiepileptic drugs throughout their pregnancies.

The FDA’s strengthened recommendations are based on the final results of the NEAD study, which showed that children exposed to valproate products in utero had decreased IQ at age 6 when compared to children who were exposed to other antiepileptic drugs.

The difference in average IQ between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs varied between 8 and 11 points depending on the antiepileptic drug.

In a June 2011 alert, the FDA released interim results from the NEAD study that showed reduced cognitive test scores in these valproate-exposed children at age 3, and at that time the drug labels were updated.

The FDA is working with the manufacturers to make changes to the drug labels to reflect this new information and to change the pregnancy category for prevention of migraine headaches to category X (the drug’s risks outweigh the drug’s benefits for this use) from category D (the drug’s benefits outweigh the drug’s risks for this use).

Valproate products will remain category D for the other two approved indications, epilepsy and manic episodes associated with bipolar disorder.

In a drug safety communication issued today, the FDA provided a summary of the new data and recommendations for health care professionals and patients.To learn more:

Share
planb-thumb

Women’s groups angered by administration morning-after pill policies

Share

planb-175By Julie Rovner, NPR News

This story comes from our partner ‘s Shots blog.

The Obama administration’s actions this week on emergency contraception have left many women’s health groups sputtering with anger.

But what really has some of the President Barack Obama’s usual allies irritated is the fact that the moves are in direct contrast to speeches he made in just the past week.

Recall that on Tuesday the Food and Drug Administration defied a federal judge’s order to make the morning-after pill available over-the-counter to women of all ages by approving a more limited scheme. On Wednesday, the Justice Department formally appealed the federal judge’s ruling.

Yet only last Friday, Obama became the first sitting president to address Planned Parenthood’s national conference.

His spirited defense of reproductive rights included this statement: “We shouldn’t have to remind people that when it comes to a woman’s health, no politician should get to decide what’s best for you.”

And on Monday, he said this to the National Academy of Sciences: “[I]n all the sciences, we’ve got to make sure that we are supporting the idea that they’re not subject to politics, that they’re not skewed by an agenda, that, as I said before, we make sure that we go where the evidence leads us.”

But now, many women’s health advocates say the administration isn’t putting its actions where the president’s rhetoric has been.

“It doesn’t square and that is what’s so disappointing,” said Nancy Northup. She’s president and CEO of the Center for Reproductive Rights, one of the groups involved in the emergency contraception lawsuit against the administration that’s prompted this week’s activity.

“There couldn’t be a clearer record than there is in this case that emergency contraception is safe and effective for all ages, that we had not one but two administrations who continued to put what they judged as the politics of the issue about contraception ahead of what’s doing right for the public health,” she said.

Health and Human Services Secretary Kathleen Sebelius overrode the FDA’s decision to remove the age restrictions in 2011. She said she was worried that the youngest teens wouldn’t understand how to use the product safely.

But that’s not a concern for the nation’s pediatricians, who support full over-the-counter access to the drug.

“We get derailed over and over again in people’s ethical and moral concerns about whether teens should be sexually active, and not that this is a safe drug that can be and should be available to all women of reproductive age,” said Dr. Cora Breuner.

She’s a professor of pediatrics at the University of Washington and co-author of the American Academy of Pediatrics position paper on Emergency Contraception.

Women’s health advocates say even the steps the FDA did take this week — to lower the age for sale of the drug without a prescription from 17 to 15 — doesn’t do much, because they still have to show identification.

“15- and 16-year-olds are much less likely to have an actual government ID with your birth date on it,” said Susan Wood, a public health professor at George Washington University and a former assistant commissioner for women’s health at FDA. “So that … doesn’t really expand access to that age group very much.”

In fact, what really worries the women’s health groups is that idea that this fight that has already gone on for more than 10 years, now could stretch out years longer.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Share

Puget Sound Blood Center hosts 10th annual ‘Faces For Life’ fundraiser

Share

Puget Sound Blood Center logoBy Katherine Loh
UW News Lab

“I say the blood center is almost like the FBI where you don’t hear about it very often and in the end it’s probably a good thing, because if we were in the front pages or the headline, it may be because we screwed something up,” said Michael Cheever, director of Development for the ‘Faces for Life’ event held by the Puget Sound Blood Center (PSBC).

The PSBC hosted its annual fundraiser gala and silent auction, ‘Faces for Life,’ on Saturday evening, April 27 at the Bellevue Hyatt Regency. Cheever oversees many of the mechanics of the event and while it may sometimes be a challenge, he is glad to be a part of it.

“We can’t be more grateful for the patients that are coming out and baring their souls to speak,” Cheever said. “Through those stories, we use it to educate people that we are more than just your typical blood bank.”

Beth Newman, an emergency room nurse in her late 30s, was on her way to work when she was t-boned by a speeding van. She is a ‘face’ for blood donors after surviving a large amount of internal damage. Gary Arvan is another ‘face’ featured for organ transplant after receiving a new liver. The third ‘face’ featured was a patient’s family in support for pediatric leukemia after their 10-year-old daughter collapsed and underwent treatment for chemotherapy.

Beth Newman

Beth Newman

Aside from the silent auction offering opportunities for paradise getaways and Seahawks tickets behind the 50-yard line, this year’s fundraiser featured a video highlighting the three patients mentioned above and their very different but powerful stories.

However, the PSBC takes pride in more than just raising money as one of four blood centers that conduct research for various programs. As a blood center with a centralized database and testing system, they were instrumental in replacing plastic jars and bottles with glass to store blood more effectively. Its researchers have found new ways to store platelets for cancer patients up to five days, giving the Fred Hutchinson Cancer Research Center an opportunity to continue with bone marrow transplants in a more effective manner. Cheever is proud of the advancements PSBC has made.

“The head of our research institute has found what he believes could be a treatment for pediatric malaria,” said Cheever. “We are lucky enough to be in Seattle where the Gates Foundation and everyone else in town who are looking at vaccines for malaria will certainly help us prevent future generations from getting it.”

Kelly Notter, a PSBC and gala volunteer stated she was very excited about being a part of their efforts.

Many of the gala’s volunteers were excited to have the video be a large part of displaying the work the blood center has aimed to achieve.

Leah Rapalee, Development Coordinator at the PSBC, agreed and said that having the “faces” as a highlight of the night’s event was very important.

“We were just looking at patients trying to show the breadth of the work that we do,” said Rapalee. “They’re also very good speakers and good at engaging with people.”

If you are looking for ways you can help the Puget Sound Blood Center, you can visit their website <http://www.psbc.org/home/index.htm> or attend a variety of their other fundraisers including ‘Golf Gets in your Blood 2013’<http://www.psbc.org/events_archive/golf2013.htm> in partners with the Bleeding Disorder Foundation of Washington, ‘Swim for Life 2013’<http://swimforlife.dojiggy.com/ng/index.cfm/ab2b696/regPages/pages/?p=102547> that funds their Leukemia patient research programs, or the ‘Taste for Life’< http://www.psbc.org/events_archive/taste2013.htm> that is put on by PSBC’s Young Professional Ambassadors volunteer group.

KATHERINE LOH is a student in the University of Washington Department of Communication News Laboratory

 

Share