Physicians attribute 26 percent of overall healthcare costs to the practice of defensive medicine according to a study released today by Gallup and Jackson Healthcare.

Physicians generally estimate that defensive medicine costs are higher overall when compared to their own personal practice. While physicians attribute an average of 26 percent of overall costs to defensive medicine, 13 percent believe the practice constitutes 50 percent or more of the cost.

Of the physicians surveyed, 73 percent agreed that they had practiced some form of defensive medicine in the past 12 months. Twenty-three percent of practicing physicians estimate that defensive medicine constitutes less than 10 percent of their practice while 29 percent estimate the percentage to be between 10 percent and less than 25 percent.

Physicians indicating they had practiced a form of defensive medicine in the last twelve months attribute 21 percent of their practice to be defensive in nature.

In the study, defensive medicine was defined in this manner: “Defensive medicine is the practice of diagnostic or therapeutic measures conducted primarily not to ensure the health of the patient, but as a safeguard against possible malpractice liability. This may include tests, prescriptions, hospitalizations and referrals that may not be medically necessary, but are viewed as providing protection from a potential lawsuit.”

Jackson Healthcare retained Gallup for the study in an effort to quantify the scope and impact of defensive medicine practices in the U.S.

Results are based on telephone interviews with 462 randomly selected US physicians. Interviews were conducted in December and January.

Source: Gallup


An article that recently appeared in El Tejano Magazine highlighted the fact that many Americans are living longer, healthier and more productive lives because of medical innovation and research.

America’s pharmaceutical research and biotechnology companies are leading the charge. The Congressional Budget Office specifically identified America’s biopharmaceutical sector as “one of the most research-intensive industries” in America.

“A strong, innovative and creative pharmaceutical research and biotechnology sector based in the United States is a real boon to American patients,” said Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA). “American patients often get access to new and better medicines well ahead of patients around the world, and this homegrown innovation not only saves lives, it helps the American economy by employing millions of Americans and pumping billions of dollars into our local and national economies,” Tauzin added.

According to a study recently published in Health Affairs, cancer patients live three years longer on average than in 1980; 83 percent of that gain is the result of new treatments. In addition, there was a nearly 50 percent decline in heart failure- and heart attack-related deaths between 1999 and 2005. The rate of AIDS deaths has fallen by more than 70 percent since highly active anti-retroviral therapies were developed, and blood pressure medicines prevented 86,000 premature deaths from cardiovascular disease and avoided 833,000 hospitalizations for heart attack and stroke in just one year, according to a 2007 study.

These and many other medical advances were driven by U.S.-based medical innovation, according to a recent study by the Tufts Center for the Study of Drug Development. In fact, the study showed that 75 percent of new drugs in recent years were first introduced in the U.S.

“It’s important to keep in mind,” said Tauzin, “that developing new therapies can be risky, expensive and time consuming. Creating a new medicine, on average, takes between 10 and 15 years and can cost $1.3 billion. But it’s an investment biopharmaceutical research companies make because nothing is as important as the search for new cures and treatments that help patients live longer, healthier lives.”

Source: Pharmaceutical Research and Manufacturers of America


FDA cancer drug approval rate highlighted in JNCI

  • Author: Health Informer
  • Filed under: Health News
  • Date: Feb 19,2010

Agency Analysis: More than 50 new cancer indications approved over a 32-month period

The U.S. Food and Drug Administration’s Office of Oncology Drug Products approved more than 50 new indications for the use of oncology and hematology drugs and biologics between July 2005, when the office began reviewing marketing applications, and the end of 2007, according to a new agency study.

During the time period, the office reviewed 60 applications from companies seeking approval to treat people with 30 different types of cancer, including breast, lung, colon, kidney, head and neck and several forms of blood cancer.

The Office of Oncology Drug Products, part of the Center for Drug Evaluation and Research (CDER), took action on 58 of the applications, approving 53 new cancer indications. Five applications were not approved, and two applications were withdrawn before any regulatory action was taken. These approved applications included indications for 18 new drugs that had not been previously approved and 35 additional indications for already approved drugs.

“Our reviews during this period focused on approving new or existing treatments based on treatment effect, patient safety, and the treatment’s risk-benefit profile,” said Rajeshwari Sridhara, Ph.D., lead author of the FDA analysis.

“We also considered the patient populations in need of additional treatment options, existing treatments, and whether this was a new molecular entity,” said Sridhara, an acting division director, in CDER’s Office of Biostatistics.

The FDA’s retrospective analysis appears in the Feb. 24, 2010, issue of the Journal of the National Cancer Institute. The journal article is available now at http://jnci.oxfordjournals.org/.

Approval data from July 1, 2005 through Dec. 31, 2007 were reviewed by the authors for this analysis. This review was started after the formation of the Office of Oncology Drug Products and the implementation in 2007 of the Food and Drug Administration Amendments Act (FDAAA). The review included indications for both conventional oncology drugs and biological oncology products reviewed in CDER. It did not include products reviewed in other FDA centers.

“The FDA used a variety of trial designs and endpoints in approving these applications. In addition, we implemented recent regulatory initiatives including accelerated approval and priority reviews to expedite the approval of these indications,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, and one of the review’s co-authors.

The accelerated approval process allows for earlier approval of drugs to treat serious diseases with an unmet medical need and is based on a surrogate endpoint, a laboratory measurement or physical sign that is used in clinical trials as an indirect measurement of clinical benefit. Under an accelerated approval, the FDA approves the drug on the condition that the drug manufacturer conducts further studies to evaluate the drug’s actual clinical benefit. Priority reviews are conducted within six months, whereas other reviews are usually reviewed in 10 months.

Other highlights from the cancer drug approvals review include:
– New treatments were approved for six of the seven most deadly forms of cancer in the United States (lung, colon, breast, ovarian, cervical and pancreatic)
– 35 of the approvals were existing products seeking new treatment indications
– New molecular entities represented 18, or 34 percent, of the 53 approvals
– Approvals included treatments for pediatric patients, supportive care indications aimed at improving the side effects of cancer therapies, and treatment options for rare diseases
– Three new treatments were approved for advanced kidney cancer
– Nine drugs received accelerated approval, a regulatory mechanism allowing the FDA to approve a drug with subsequent studies performed after approval to demonstrate an effect on survival or other clinically meaningful endpoints
– Twenty five percent of the indications approved were based on improvement in overall survival or improvement in both progression-free survival and overall survival

Other authors of the review include: John R. Johnson, M.D., Clinical Team Leader, Robert Justice, M.D., director of the Division of Drug Oncology Products, Patricia Keegan, M.D., director of the Division of Biologic Oncology Products and Aloka Chakravarty, Ph.D., acting division director, Division of Biometrics VII, Office of Biostatistics.

Source: U.S. Food and Drug Administration


DTU-2231 and DTU-1631 Provide Direct Pen-on-screen Workflow for Increased Efficiency and Productivity; DTU-2231 Serves as First HD Interactive Pen Display Aimed at Medical Industry

Providing streamlined and intuitive digital workflows within the medical industry, Wacom® has amplified the opportunity to increase production rates and comfort with the introduction of the DTU-2231 and DTU-1631 interactive pen displays. Offering the ultimate in control, the new DTU models’ direct pen-on-screen input is designed to optimize efficiency and productivity by allowing healthcare professionals to draw diagrams, write notes or annotate directly on digital images.

“Our goal is to positively impact, and elevate, the way people interact with their digital data,” said Senior Wacom Product Manager, Stan Ueno. “With excellent resolution and widescreen formatting, the DTU-2231 and DTU-1631 raise the bar for medical professionals seeking higher levels of detail, accuracy and efficiency. This, combined with the vast array of other high-performance interactive pen display models offered by Wacom, provides medical professionals unlimited options to improve image editing, recordkeeping, education and more.”

DTU-2231: First HD Interactive Pen Display for Radiology, EMR and Other Applications

Featuring a 21.5″ widescreen LCD with a 1920 x 1080 resolution, the DTU-2231 allows radiologists, physicians and other medical professionals to contour directly on CT slices, take measurements of complex objects, highlight points of interest and make handwritten comments on a given image. The DTU-2231 increases control, accuracy and productivity in addition to providing users the ability to collaborate and share treatment plans electronically. This opens the door to improved communication between staff within the medical community. At a growing rate, healthcare professionals are combining Wacom’s interactive pen technology with software applications such as Eclipse, Pinnacle and RealArt to experience up to a 60 percent decrease in time requirements for image contouring and radiation volume targeting. Moreover, Wacom interactive pen displays can be found at Oregon Health & Science University, Seattle’s Swedish Medical Center and numerous other leading medical institutions.

The flexibility and ease-of-use inherent in the DTU-2231 also make it an ideal tool for Electronic Medical Records (EMR) management. From reviewing and signing legally binding patient admission, insurance and consent forms to using the pen display as an educational tool during medical school, the DTU-2231 is an elite multi-tasking device for healthcare professionals.

DTU-1631: Fueling Efficiency for Medical Administrative Professionals

Created to accommodate professionals requiring advanced widescreen interactive pen display capabilities in a more compact form factor, the DTU-1631 makes the capture of EMR simple and fast for both healthcare professionals and patients. The more compact DTU-1631, a 15.6″ LCD with a 1366 x 768 resolution, is a comfortable size for populating patient data such as signature capture for patient admission and consent.

“The natural and intuitive ‘pen-on-paper’ feel of the DTU-1631 paves the way for a paperless organization, allowing administrative professionals a cost-effective and streamlined way to work,” continues Ueno.

Tier one healthcare organizations such as San Diego’s Sharp HealthCare and Lennox Hill of New York employ Wacom interactive pen displays for hospital-patient administrative tasks and report measurable savings.

DTU-2231 and DTU-1631 Features Include:
Cordless, Battery-free Pen: With 512 levels of pressure sensitivity, the pen provides a tip switch, two customizable side switches, an eraser switch and tether hole
Built-in USB Hub: With two user-accessible USB ports
Video Pass-Thru: DVI-I (digital or analog) input, DVI-I output and video scaler
Completely Flat Work Surface: 16:9 aspect ratio and adjustable stand; the DTU-2231 additionally offers anti-reflective treatment

Competitively priced, the Wacom DTU-2231 (USD $1,899 MSRP) and DTU-1631 (USD $1,249 MSRP) will be available for purchase in spring 2010.


Categories

Archives

Blogroll

Meta