Tag: FDA

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.

What Is Causing Drug Shortages?

Mar 19, 2012• 3

By Michael F. Cannon

A number of people have asked me what is causing the current shortages in certain types of drugs. Here’s what I’ve been able to discern so far:

In general, there are two reasons why shortages might appear in a market. The first is high fixed costs. These include regulatory costs, the costs of converting a manufacturing plant to a new use, or the costs of creating a new factory. Industries with high fixed costs will see temporary shortages after either supply shocks (e.g., a factory goes offline) or demand shocks (e.g., an increase in the population needing a drug). The price mechanism eventually resolves such shortages. The duration of the shortage is related to the size of the fixed costs.

Shortages also appear when something interferes with the price mechanism’s ability to resolve a shortage. The classic example is government price controls (i.e., a binding price ceiling). Such shortages persist as long as the price controls (e.g., rent control) remain in place and binding.

From my study of the current spate of drug shortages, the best accounting for these shortages appears in this publication by the U.S. Department of Health and Human Services: “Economic Analysis of the Causes of Drug Shortages,” Issue Brief, October 2011.

I initially suspected these drug shortages were caused by Medicare’s Part B drug-payment system. Others, including Scott Gottleib and the Wall Street Journal, have made that claim. However, this study and a lengthy discussion with the U.S. Department of Health and Human Services’ assistant secretary for planning and evaluation have persuaded me that not only is Medicare’s Part B drug-payment system not the cause, that system doesn’t even impose binding price controls. Rather, it controls the margins that physicians earn for administering a drug. (If Medicare did impose binding price controls, would we see mark-ups of 650 percent or more for the shortage drugs?)

Rather, the shortages appear to be the result of a number of dynamics in the market for rare drugs:

The Bottom Line

Mar 5, 2012• 10

By Kelly Wright, MD

It’s cool. So cool, that President Obama used one. So cool, it’s been on the cover of Newsweek. It’s been in multiple television commercials, radio advertisements, highway billboards, and was even coined one of the top 14 medical breakthroughs of 2011 by Boston Magazine, a city teeming with medical innovation. Yet surgeons and health economists are unable to explain the fascinating rise of robotic-assisted surgery.

Currently, a single company manufactures and distributes the robot, a line of surgical equipment used to conduct robotic-assisted surgery. The robotic system consists of a surgeon’s console with 3-dimensional high definition vision and a patient-side cart featuring robotic arms with proprietary wristed instruments. The system translates the surgeon’s natural hand movements on instrument controls into corresponding movements of instruments inside the patient, giving the surgeon control, range of motion, and depth of vision similar to open surgery.

The sole manufacturer hopes to establish the robot as the standard for surgical procedures by encouraging surgeons and hospitals to adapt the technique while marketing aggressively to patients about the benefits of robotic surgery. As of June 2011, the manufacturer had installed 1,933 robotic systems. They estimate that 278,000 robotic-assisted surgical procedures were performed in 2010, up 35% from 2009, and aims to achieve one million annual procedures in the United States over the next few years (Invester Report 2011). To achieve this goal, the manufacturer strategically markets to smaller hospitals and surgeons who may not be skilled at conventional laparoscopy to give them an edge for attracting patients.

Off-label Drug Promotion and the First Amendment

Nov 3, 2011• 1

By David E. Williams

Doctors can and often do prescribe medications for different purposes than what the FDA has approved them for. But drug companies face tight restrictions on communicating with physicians about these so-called “off-label” uses. If the pharmaceutical industry has its way, those restrictions may soon ease. Such a change would be healthy overall.

Drugs undergo clinical trials for specific indications, such as Avastin for colorectal cancer. The label received from the FDA upon approval allows the manufacturer to promote the drug to physicians for those specific indications only. But a drug that works for one disease may work for a related disorder (e.g., another form of cancer) or something that seems totally different, like macular degeneration. Often the drug company will follow its initial clinical trials with trials for other indications in order to broaden the label and expand sales, but salespeople can’t bring up these uses until they’re officially on-label.

Drug companies get in trouble all the time for off-label promotion. According to the Wall Street Journal (The Free Speech Pill), 15 off-label cases were settled between 1996 and 2010 for a total of $8.7B.

FDA Should Consider Cost in Some Decisions

Oct 5, 2011• 3

By STEVEN GROSSMAN

FDA decides whether drugs, biologics and medical devices are safe and effective and can be marketed legally in the United States. The agency analyzes risk-benefit, but never cost. In contrast, public and private insurers, along with physicians and pharmacists, have the responsibility for cost-benefit decision making.

I have always felt quite strongly that this was the right way to allocate roles. Safety and efficacy determinations are difficult enough without weighing cost, so keeping a barrier between them makes sense. Two events this past week have left me wondering whether there are certain limited circumstances when FDA should be able to take product cost into consideration.

On September 26, 2011, The Oncology Commission of the British medical journal, Lancet, released a report entitled: “Delivering Affordable Cancer Care in High-Income Countries.” The 40-page report is wide-ranging, but its conclusion straightforward: as cancer care grows more expensive (and it is doing so at a rapid pace), affordability, accessibility and value are issues that need to be confronted aggressively.

Is FDA Getting Ready to Stifle Innovation in Diagnostic Software?

Jul 27, 2011

By DAVID E. WILLIAMS

FDA is proposing regulation for mobile medical applications. Not a bad idea. But I have some concerns about what it will mean for clinical diagnostics software. Here’s the definitional passage:

Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.

Apps that provide differential diagnosis tools for a clinician to systematically compare and contrast clinical findings (symptoms/ results, etc.) to arrive at possible diagnosis for a patient.