Tag: FDA

Medical Apps: The Next Generation

Aug 23, 2012• 3

By Kenny Lin, MD

Doctors of my generation have experienced dramatic changes in the way we access the information we need to care for patients.

As a medical student 15 years ago, my “peripheral brain” consisted of fat textbooks sitting on office bookshelves or smaller, spiral-bound references stuffed into the bulging pockets of my lab coat. As a doctor-in-training, I replaced those bulky references with programs loaded onto PDAs. Today, smartphone apps allow health professionals at all levels to access the most up-to-date medical resources such as drug references, disease-risk calculators, and clinical guidelines—anytime, anywhere.

Apps have several advantages over traditional medical texts. First, the information is always current, whereas many textbooks are already dated by the time they hit shelves. If I have a question, I can look up the answer on my smartphone without leaving my patient’s side. And unlike textbook chapters, many medical apps have interactive features that help doctors choose appropriate screening tests for patients, recognize when immunizations are due, or calculate a patient’s risk of developing heart problems.

Lastly, apps can enable remote monitoring of high-risk patients and reduce the need for office visits. In a small study published in PLoS ONE, for example, researchers found that patients hospitalized for heart vessel blockages were able to complete “supervised” rehabilitation exercise sessions in their homes with a portable heart monitor and GPS receiver that transmitted real-time data to doctors via smartphone.

Why the Electronic Medical Record Needs to be Viewed as a Medical Device

Aug 20, 2012• 20

By WESTBY FISHER, MD

In our rush to establish a national electronic medical record (EMR) system as part of the American Recovery and Reinvestment Act of 2009, powerful silos of independent EMR systems have sprung up nationwide.

While most systems are being developed responsibly, like the Wild, Wild West, many have been developed without an objective eye toward quality and the potential harm they may be causing our patients.

As most readers of this blog are aware, since 2005 the medical device industry in which I work has had widely publicized instances of patient deaths splashed all over the New York Times and other mainstream media outlets from defibrillator malfunctions that resulted in a just a few patient deaths.

The backlash in response to these deaths was significant: device registries were developed, software improvements to devices created, and billions of dollars in legal fees and damages paid to patients and their families on the path to improvement. In addition, we also learned about the limits of corporate responsibility for these deaths thanks to legal precedent established by the Reigel vs. Medtronic case.

Obesity: Global Public Health Challenge or Investment Opportunity?

Aug 3, 2012• 5

By Marion Nestle

Worried about the potential personal and economic costs of obesity? Never mind. It’s time to view obesity as a business opportunity.

As the press release for a new research report from Bank of America Merrill Lynch, Globesity—The Global Fight Against Obesity, points out:

“Increasing efforts to tackle obesity over the coming decades will form an important new investment theme for fund managers…Global obesity is a mega-investment theme for the next 25 years and beyond…The report…identifies that efforts to reduce obesity is a “megatrend” with a shelf-life of 25 to 50 years…BofA Merrill Lynch analysts across several sectors have collaborated to identify the sectors and companies developing long-term solutions.”

Given the worldwide increase in obesity, its high prospective costs, and the ever-present threat of government regulation, the report identifies more than 50 global stocks that provide investment opportunities for fighting “globesity.” These fall into four categories:

Pharmaceuticals and Health Care: companies taking advantage of the FDA’s increased support for obesity drug development; tackling related medical conditions and needs including diabetes, kidney failure, hip and knee implants; making equipment such as patient lifts, bigger beds and wider ambulance doors.
Food: companies accessing the $663 billion “health and wellness” market and reformulating portfolios to respond to increasing pressure such as “fat taxes” to reduce sugar and fat levels.

How the iPhone Might Disrupt The Medical Device Industry

Jul 27, 2012• 10

By Dr. Wes

Doctors wanting to determine a patient’s atrial fibrillation burden have a myriad of technologies at their disposal: 24-hour Holter monitors, 30-day event monitors that are triggered by an abnormal heart rhythm or by the patient themselves, a 7-14 day patch monitor that records every heart beat and is later processed offlineto quanitate the arrhythmia, or perhaps an surgically-implanted event recorder that automatically stores extremes of heart rate or the surface ECG when symptoms are felt by the patient. The cost of these devices ranges from the hundreds to thousands of dollars to use.

Today in my clinic, a patient brought me her atrial fibrillation burden history on her iPhone and it cost her less than a $10 co-pay. For $1.99 US, she downloaded the iPhone app Cardiograph to her iPhone.

Every time she feels a symptom, she places her index finder over the camera on the phone, waits a bit, and records a make-believe rhythm strip representing each heart rhythm. With it, comes the date and time.

Clinical Trials for Beginners

Jul 16, 2012• 8

By Judy Stone, MD

Have you ever wondered about what goes on behind the scenes—how new drugs are magically produced and brought forth? We’ll continue to take the mystery out of clinical research and drug development and to provide background information so that both patients and physicians can make more informed decisions about whether they wish to participate in clinical trials or not.

Why care?

To develop a medicine, from the time of discovery of the chemical until it reaches your drug store, takes an average of 12-15 years and the participation of thousands of volunteers in the process of clinical trials (Fig 1).

Very few people participate in clinical trials—it is even less than 5% for patients with cancer—due to lack of awareness or knowledge about the process. We’ll go into detail about how drugs are developed in later posts.

An inadequate number of volunteers is one of the major bottlenecks in drug development, delaying the product’s release and usefulness to the public. Of course, many people may suffer or even die during this wait, if they have an illness that is not yet otherwise treatable. So if you want new medicines, learn about—and decide if you wish to participate in—the process. I have, as a volunteer subject, researcher, and advocate.Continue reading…

The Wrong Way to Stop Fake Drugs

May 25, 2012• 3

By Roger Bate

In 2007-8, when counterfeit versions of heparin, a blood-thinning drug, were shipped from China to the United States market, 149 people died. In the last few months, bogus versions of the cancer drug Avastin, apparently shipped from the Middle East, have surfaced in clinics in California, Illinois and Texas. Thankfully, so far as we know, they haven’t killed anyone, but more and more cases of dangerous fake drugs are being reported by the Food and Drug Administration. Numerous incidents surely go unreported, the evidence swallowed, the deaths incorrectly attributed to natural causes.

Fighting the fake-drug menace is like playing whack-a-mole. It is technically illegal for individuals to order drugs online from other countries. And yet no sooner does the F.D.A. shut down one dubious online pharmacy than another pops up. According to the National Association of Boards of Pharmacy, only 3 percent of the 9,600 online pharmacies it has reviewed complied with industry standards. Many were based overseas, so their sales to Americans were illegal; others did not require doctors’ prescriptions. And some were very likely peddling dangerous counterfeit drugs.

Expand Over-the-Counter Medications? Very Bad Idea

May 18, 2012• 3

By Marc Siegel, MD

The Food and Drug Administration is considering removing prescription requirements for medications that treat common conditions, such as high blood pressure, diabetes, asthma, migraines and high cholesterol. This means that you would be able to go to your local pharmacy, fill out a questionnaire, receive a diagnosis and purchase a medication, all without intervention or direction from a physician.

As a doctor, I think this is a very bad idea. Although it is true that diagnoses are often missed — reports estimate that as many as 7 million diabetics in the U.S. remain undiagnosed — and although easier access to drugs could theoretically encourage patients to take their medications, I am concerned that expanding over-the-counter access will lead to wrong diagnoses with improper treatments, which carry side effects.

Remember, medicine is an art, practiced on an individual basis. A medication that works for one person doesn’t always work for another. I am constantly changing cholesterol or high blood pressure medications for my patients because of unanticipated side effects such as muscle aches or dizziness.

Lack of follow up

What would happen if I weren’t involved to monitor treatments and make necessary changes? The upfront cost savings from cutting out doctors and their office fees will be more than made up by longer term costs of improper diagnoses or unmonitored complications.

Advocates of expanding over-the-counter medications point to aspirin or allergy drugs as examples that have proved successful without a doctor’s prescription. But for every patient who is glad not to have to visit my office for an allergy prescription, I can point to another patient who has suffered side effects like fatigue that he or she didn’t realize were due to that same pill, or where the allergic reaction was due instead to food.

The fact that common painkillers have been available over the counter for decades also doesn’t provide a convincing argument for bypassing prescriptions. Consider that more than 100,000 Americans are hospitalized every year due to bleeding from aspirin or other OTC non-steroidal anti-inflammatory pills, and acetaminophen is the No. 1 cause of acute liver failure.Continue reading…

Don’t Bypass Physicians

May 13, 2012• 3

By Peter W. Carmel

As physicians, our primary concern is ensuring the health and safety of our patients. The Food and Drug Administration has offered a new concept to make more prescription drugs available over the counter (OTC). Proponents claim it could improve patient health and outcomes, reduce patient costs and promote proper medication use. We are skeptical that it would achieve any of these goals.

The American Medical Association is concerned about patients taking certain drugs without physician involvement — especially patients with chronic diseases. No evidence has been offered that the innovative technologies underpinning this concept would actually allow patients with high blood pressure, high cholesterol, asthma or migraine headaches to self-diagnose and manage these serious chronic medical conditions safely on their own.

As a chronic condition evolves, treatment changes are often needed from a physician. Without physician involvement, patients might take the wrong medication or dose for their needs, potentially causing harm. Self-diagnosis and treatment conflict with the care coordination and disease management that new health care payment and delivery models are trying to achieve.

Heroin Vaccine Won’t Cure What Ails Addicts

Apr 19, 2012• 5

By Angela Garcia

My aunt Marion is in the hospital dying of liver and kidney failure, the result of her 20-year struggle with heroin use. I was told of her imminent death the same day news broke about a vaccine against the drug. “Breakthrough heroin vaccine could render drug ‘useless’ in addicts,” one headline read. “Scientists create vaccine against heroin high,” proclaimed another.

Meanwhile, my aunt finds temporary relief in the ever more frequent administration of opiate pain medication — the very kind of drugs she used illegally.

The idea of an anti-addiction vaccine is not new. For nearly 40 years scientists have been working on vaccines against all kinds of addictions, including nicotine, marijuana and alcohol. There are even trials of vaccines to prevent obesity. None of the anti-addiction vaccines has yet received Food and Drug Administration approval, however, and most of the studies are still in their early stages.

The headlines trumpeting a heroin vaccine were based on a finding that the drug had proved to be effective on mice during trials in Mexico (a nation that could use some good news related to drugs). Scientists now plan to test the patented vaccine in humans. If all goes well, the vaccine could be available in five years — too late for my aunt but providing a glimmer of hope for the estimated 1 million heroin addicts in the United States. Perhaps.

Six years ago, when I was a doctoral student researching heroin addiction in northern New Mexico, I received an email from a scientist studying a possible vaccine against the drug’s use. The study was in rat models, but early results were promising and suggested the likelihood of a therapeutic effect for humans. Aware of the devastating heroin epidemic in New Mexico, which had the highest rate of heroin-related deaths in the Unites States, and of my work trying to understand it, the scientist wanted to offer some hope. He wrote that he could imagine a time when heroin addiction, in New Mexico and around the world, would be a thing of the past. I wanted to believe him, but I was less optimistic.

The Drug Shortage Wars

Apr 9, 2012• 6

By Sanjay Bansu, MD

“I should have gotten cancer last month,” she told me.

That was the first thought from my patient after she’d heard the news: her ovarian cancer would remain untreated for weeks, due to a critical shortage of the chemotherapy agent doxorubicin. Like her, several thousand patients have been affected by critical shortages of chemotherapy agents like doxorubicin (Doxil) and methotrexate—common medicines that are essential backbones of cancer chemotherapy. But hundreds of other people have also been affected by critical shortages of pills around the country—limiting the supply of critical ICU medications like intravenous versed, or tuberculosis drugs like isoniazid.

Why are these shortages happening, and what can be done about them?

The state of the problem

Doxil and methotrexate are among 287 drugs in “critical shortage” in the United States, according to the University of Utah’s Drug Information Service, which has been tracking the problem. Shortages have been mounting in recent years, up from about 74 in 2005.

At present, the US Food and Drug Administration and independent researchers have tracked the status of major drug shortages occurring throughout the country. The FDA keeps an online catalog of these shortages. What this catalog reveals is that among 178 drugs that were in shortage during the year 2010, a vast majority (132) were sterile injectable drugs. These are generally cancer drugs, anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding.