Tuesday, June 22, 2010

FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market

Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.

Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.

Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.

A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.

At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.

“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”

As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.

Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.

Mylotarg is manufactured by New York City-based Pfizer.

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Monday, June 21, 2010

FDA Approves First Diagnostic Assay to Detect Both HIV Antigen and Antibodies

/USNewswire/ -- The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

The highly sensitive assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the ARCHITECT HIV Ag/Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies. Most tests used today in the diagnostic setting detect HIV antibodies only. Although direct detection of the virus itself by nucleic acid testing is available, it is not widely used in diagnostic settings.

HIV is the virus that can lead to acquired immune deficiency syndrome, or AIDS. HIV damages a person's body by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified: HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.

The Centers for Disease Control and Prevention report that approximately 18 million people in the United States are tested for HIV each year. Most recent CDC estimates are that there are about 56,000 new HIV infections in the United States each year. In addition, there are more than 1 million people living with HIV in the United States, according to CDC.

"The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research. "It provides for more sensitive detection of recent HIV infections compared with antibody tests alone."

The ARCHITECT HIV Ag/Ab Combo assay is not intended to be used for routine screening of blood donors. However, it is approved as a donor screening assay for HIV-1/HIV-2 infection in urgent situations where licensed blood donor screening tests are unavailable or their use is impractical.

The ARCHITECT HIV Ag/Ab Combo assay will be used in clinical laboratories and in public health laboratories, and is the first assay approved in the United States to detect HIV antigen and antibodies simultaneously.

The ARCHITECT HIV Ag/Ab Combo assay is manufactured by Abbott Laboratories, Abbott Park, Illinois.

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FDA Approves New Indication for Tasigna

The U.S. Food and Drug Administration on June 17 approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

Tasigna is believed to work by blocking a signal that leads to leukemic cell development. The new indication expands the use of Tasigna to adult patients in earlier stages of the disease. The FDA originally approved Tasigna in October 2007 for the treatment of Ph+CP-CML in adult patients whose disease had progressed or who could not tolerate other therapies, including Gleevec (imatinib).

When Tasigna was originally approved in October 2007, the FDA identified that the therapy placed patients at risk of an abnormal heart rhythm called QT prolongation. In March 2010, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Tasigna to help patients and health care professionals to better understand this risk. The REMS includes an updated Medication Guide and a communication plan to help reduce medication errors involving drug-food interactions and incorrect dosing intervals.

“It’s important for companies to continue developing oncology drugs for earlier stages of the disease once they have demonstrated clinical effectiveness in resistant forms of cancer,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, part of the FDA’s Center for Drug Evaluation and Research. “This approach has the potential to increase the availability of an effective treatment to more patients.”

In CML, too many blood stem cells develop into a type of white blood cell called granulocytes. These granulocytes are abnormal and do not become healthy white blood cells. These cells can build up in the blood and bone marrow so there is less room for healthy white blood cells, red blood cells, and platelets. When this happens, infection, anemia, or unexpected bleeding may occur.

The FDA granted Tasigna a priority review for Ph+ CP-CML. The agency completed the review in six months. The new indication for Tasigna was approved under the FDA’s accelerated approval program, which allows FDA to approve a drug to treat serious diseases with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit. The company is required to collect additional long term efficacy and safety information data confirming the drug’s benefit. The accelerated approval program provides earlier patient access to promising new drugs while the confirmatory clinical trials are being conducted.

The safety and effectiveness of Tasigna were evaluated in a single clinical trial enrolling 846 patients with newly diagnosed Ph+ CP-CML. Patients received either Tasigna or Gleevec until the disease worsened, or until unacceptable side effects developed. The study was designed to measure a significant reduction in the surrogate endpoint of the number of CML cancer cells in the blood stream (i.e., major molecular response) at 12 months. About 44 percent of patients who received Tasigna experienced a major molecular response, compared with 22 percent of patients receiving Gleevec.

In patients with newly diagnosed CP-CML, the most commonly reported non-blood-related adverse drug reactions were rash, itching (pruritus), headache, nausea, fatigue, and muscle pain (myalgia). Serious blood-related drug reactions included decrease in bone marrow activity (myelosuppression), low level of platelets in the blood (thrombocytopenia), decrease in infection-fighting white blood cells (neutropenia), and anemia.

Other FDA-approved drugs to treat CML include Gleevec in May 2001 and Sprycel (dasatinib) in June 2006. Tasigna and Gleevec are marketed by East Hanover, N.J.-based Novartis Pharmaceuticals. Sprycel is marketed by New York City-based Bristol-Myers Squibb.

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ONC Issues Final Rule to Establish the Temporary Certification Program for Electronic Health Record Technology

The Office of the National Coordinator for Health Information Technology (ONC) on June 18 issued a final rule to establish a temporary certification program for electronic health record (EHR) technology. The temporary certification program establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology.

Use of “certified EHR technology” is a core requirement for providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs provisions authorized in the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH was enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009. The Centers for Medicare & Medicaid Services will soon issue final regulations to implement the EHR incentive programs.

Certification is used to provide assurance and confidence that a product or service will work as expected and will include the capabilities for which it was purchased. EHR technology certification does just that: It assures health care providers that the EHR technology they adopt has been tested and includes the required capabilities they need in order to use the technology in a meaningful way to improve the quality of care provided to their patients.

On March 10, 2010, the U.S. Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPRM) entitled Proposed Establishment of Certification Programs for Health Information Technology. The NPRM proposed the establishment of two certification programs for purposes of testing and certifying EHRs —one temporary and one permanent. The temporary certification program final rule issued today will become effective upon publication in the Federal Register. The final rule for the permanent certification program is expected to be published this fall.

“By purchasing certified EHR technology, hospitals and eligible professionals and hospitals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system,” said David Blumenthal, M.D., M.P.P., national coordinator for health information technology. “We hope that all HIT stakeholders view this rule as the federal government’s commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs.”

This final rule is issued under the authority provided to the National Coordinator for Health Information Technology in section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the HITECH Act.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification.

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Sebelius Announces New $250 Million Investment to Lay Foundation for Prevention and Public Health

U.S. Department of Health and Human Services Secretary Kathleen Sebelius on June 18 announced $250 million in new Affordable Care Act investments to support prevention activities and develop the nation’s public health infrastructure.

Chronic diseases, such as heart disease, cancer, stroke, and diabetes, are responsible for 7 of 10 deaths each year among Americans, and account for 75 percent of the nation’s health spending. Many Americans engage in behaviors such as tobacco use, poor diet, physical inactivity, and alcohol abuse, which harm their health.

“Investing in prevention and public health builds the foundation for improving the health and well-being of Americans, and for lowering costs in the health care system,” said Secretary Sebelius. “Investing in proven preventive services will help patients get the care they need early, avoiding costly and unnecessary care later. This prevention-focused approach is better for doctors, patients, and our national balance sheet.”

The investments announced today in prevention and public health are the second allocation for fiscal year 2010 from the new $500 million Prevention and Public Health fund created by the Affordable Care Act.

The $250 million investment in prevention and public health will go to:

* Community and Clinical Prevention: $126 million will support federal, state and community prevention initiatives; the integration of primary care services into publicly funded community-based behavioral health settings; obesity prevention and fitness; and tobacco cessation.
* Public Health Infrastructure: $70 million will support state, local, and tribal public health infrastructure and build state and local capacity to prevent, detect, and respond to infectious disease outbreaks.
* Research and Tracking: $31 million for data collection and analysis; to strengthen CDC’s Community Guide by supporting the Task Force on Community Preventive Services; and to improve transparency and public involvement in the Clinical Preventive Services Task Force.
* Public Health Training: $23 million to expand CDC’s public health workforce programs and public health training centers.

“With these investments, we are tackling the underlying causes of chronic diseases as well as strengthening our ability to meet the public health challenges of the 21st century,” said Surgeon General Regina M. Benjamin. “This moves America in the direction of becoming a fit and healthy nation.”

Earlier this week, Secretary Sebelius announced the allocation of the first half of the Prevention and Public Health fund to increase the number of clinicians and strengthen the primary care workforce. Building on the earlier investments made by the American Recovery and Reinvestment Act of 2009 and the Affordable Care Act, particularly for the National Health Service Corps, the investments will support the training and development of more than 16,000 new primary care providers over the next five years.

With these investments and others, the Affordable Care Act is continuing the Obama Administration’s historic work to promote wellness and reduce chronic disease. The new law also calls for a national strategy to improve the nation’s health, eliminates co-pays for key preventive services like cancer screenings, and provides new support for employer wellness programs.

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Thursday, June 17, 2010

FDA Approves New Treatment for Advanced Prostate Cancer

USNewswire/ -- The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

In prostate cancer, the male sex hormone testosterone can cause prostate tumors to grow. Drugs, surgery, or other hormones are used to reduce testosterone production or to block it. Some men have hormone refractory prostate cancer, meaning the prostate cancer cells continue to grow, despite testosterone suppression. Different treatments are needed for men with this type of cancer.

Jevtana was reviewed under the FDA's priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Jevtana received approval ahead of the product's Sept. 30, 2010, goal date.

"Patients have few therapeutic options in this disease setting," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, part of the FDA's Center for Drug Evaluation and Research. "FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer."

Jevtana's safety and effectiveness was established in a single, 755-patient study. All study participants had previously received docetaxel. The study was designed to measure overall survival (the length of time before death) in men who received Jevtana in combination with prednisone compared with those who received the chemotherapy drug, mitoxantrone, in combination with prednisone. The median overall survival for patients receiving the Jevtana regimen was 15.1 months compared with 12.7 months for those who received the mitoxantrone regimen.

Side effects in those treated with Jevtana included decrease in infection-fighting white blood cells (neutropenia), anemia, decrease in the number of white blood cells (leukopenia), low level of platelets in the blood (thrombocytopenia), diarrhea, fatigue, nausea, vomiting, constipation, weakness (asthenia), and renal failure.

Prostate cancer, which usually occurs in older men, is the second most common cancer among men in the United States, behind skin cancer. In 2006, the most recent year for which numbers were available, 203,415 men developed prostate cancer and 28,372 men died from the disease, according to the Centers for Disease Control and Prevention.

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Wednesday, June 16, 2010

Sebelius Announces New $250 Million Investment to Strengthen Primary Health Care Workforce

U.S. Department of Health and Human Services Secretary Kathleen Sebelius today announced a series of new investments worth $250 million to increase the number of health care providers and strengthen the primary care workforce. The new investments were made possible by the Affordable Care Act. Sebelius was joined for the announcement by U.S. Representative Lois Capps, Health Resources and Services Administration (HRSA) Administrator Dr. Mary Wakefield, and HHS Assistant Secretary for Health Dr. Howard K. Koh.

Communities across the country have long suffered from a shortage of primary care providers. Without action, experts project a continued primary care shortfall due to the needs of an aging population and a decline in the number of medical students choosing primary care. The Association of American Medical Colleges estimated that the nation would have a shortage of approximately 21,000 primary care clinicians in 2015. Building on the earlier investments made by the American Recovery and Reinvestment Act of 2009 and the Affordable Care Act, particularly for the National Health Service Corps, the investments announced today will support the training and development of more than 16,000 new primary care providers over the next five years.

"These new investments will strengthen our primary care workforce to ensure that more Americans can get the quality care they need to stay healthy," said Secretary Sebelius. "Primary care providers are on the front line in helping Americans stay healthy by preventing disease, treating illness, and helping to manage chronic conditions. These investments build on the Administration's strong commitment to training the primary care doctors and nurses of tomorrow and improving both health care quality and access for Americans throughout the country."

"The Affordable Care Act's goal of increasing access to quality, affordable care can only be accomplished if we train the next generation of health professionals to provide it," said Representative Capps. "This critical investment will help alleviate the current shortage of primary health care providers including physicians, physician assistants and nurses. Increasing the number of primary care professionals will allow us to place an increased emphasis on preventive care and wellness - something I've devoted my life to as a public health nurse -- making this country healthier in the long run. I applaud the President, Secretary Sebelius, Assistant Secretary Koh and Administrator Wakefield for swiftly working to roll out this important provision of health care reform."

The investments announced today in the primary care workforce are the first allocation from the new $500 million Prevention and Public Health fund for fiscal year 2010, created by the Affordable Care Act. Half of this fund - $250 million - will be used to boost the supply of primary care providers in this country by providing new resources for:

* Creating additional primary care residency slots: $168 million for training more than 500 new primary care physicians by 2015;

* Supporting physician assistant training in primary care: $32 million for supporting the development of more than 600 new physician assistants, who practice medicine as members of a team with their supervising physician, and can be trained in a shorter period of time compared to physicians;

* Encouraging students to pursue full-time nursing careers: $30 million for encouraging over 600 nursing students to attend school full-time so that they have better odds of completing their education;

* Establishing new nurse practitioner-led clinics: $15 million for the operation of 10 nurse-managed health clinics which assist in the training of nurse practitioners. These clinics are staffed by nurse practitioners, which provide comprehensive primary health care services to populations living in medically underserved communities.

* Encouraging states to plan for and address health professional workforce needs: $5 million for states to plan and implement innovative strategies to expand their primary care workforce by 10 to 25 percent over ten years to meet increased demand for primary care services.

"With these health care workforce investments, we have a unique opportunity to further strengthen our primary care workforce for the future," said Dr. Wakefield. "Today's announcement is a strong indication of our commitment and one of many steps in the right direction."

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Monday, June 14, 2010

Study Sheds Light on a Potential Cause of Insomnia

In a study at Emory University, investigators have shed new light on a potential cause of insomnia, demonstrating that products of the immune system called cytokines may be the culprits. The study was published May 25, 2010 in the journal Biological Psychiatry.

Insomnia is a common sleep problem of unknown cause that occurs in about 10 percent of the population.

“Sleep disturbances are debilitating and often plague patients who have medical and psychiatric illnesses, exacerbating their conditions,” says Andrew Miller, MD, senior author and principal investigator of the study.

Miller is the William P. Timmie Professor of Psychiatry and Behavioral Sciences, Emory University School of Medicine, and director of Psychiatric Oncology, Winship Cancer Institute of Emory University.

“Our data suggests that cytokines may provide a link between disorders associated with chronic activation of the immune system, including medical and/or psychiatric illnesses and insomnia, which in turn is associated with fatigue and other problems,” says Miller.

Cytokines are fundamental signaling molecules of the immune system that allow communication of immune cells with each other as well as communication with other tissues, including the brain.

In the Emory study, participants were exposed to standardized doses of the cytokine interferon (IFN)-alpha for the treatment of hepatitis C where it activates the immune system to fight the virus.

During the three months the individuals were exposed to IFN-alpha, they showed marked deterioration of their sleep patterns. They woke up repeatedly during the night and spent much less time in the restorative, deep stages of sleep. During the day, these individuals were extremely fatigued. However, even when offered a nap, they still couldn’t sleep.

The investigators believe these findings may hold promise for novel treatments of insomnia that target the effects of cytokines on sleep. The team is currently conducting a follow-up study to determine if blocking cytokines improves sleep in depressed patients.

In addition to Miller, researchers participating in the study include Charles Raison, MD, David B. Rye, MD, Bobbi J. Woolwine, MSW, Gerald J. Vogt, PhD, Breanne M. Bautista, RN, and James R. Spivey, MD, from the Emory Departments of Psychiatry, Neurology and Digestive Diseases.

The National Institute of Mental Health funded the study. The abstract can be found at PubMed at http://www.ncbi.nlm.nih.gov/pubmed/20537611.

“Chronic interferon-alpha administration disrupts sleep continuity and depth in patients with hepatitis C: association with fatigue, motor slowing and increased evening cortisol.” Biol Psychiatry.

The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research, health care and public service. Its components include the Emory University School of Medicine, Nell Hodgson Woodruff School of Nursing, and Rollins School of Public Health; Yerkes National Primate Research Center; Winship Cancer Institute of Emory University; and Emory Healthcare, the largest, most comprehensive health system in Georgia. Emory Healthcare includes: The Emory Clinic, Emory-Children's Center, Emory University Hospital, Emory University Hospital Midtown, Wesley Woods Center, and Emory University Orthopaedics & Spine Hospital. The Woodruff Health Sciences Center has $2.3 billion in operating expenses, 17,600 employees, 2,500 full-time and 1,500 affiliated faculty, 4,700 students and trainees, and a $5.7 billion economic impact on metro Atlanta. Learn more about Emory’s health sciences: http://emoryhealthblog.com - @emoryhealthsci (Twitter) - http://emoryhealthsciences.org

Op-Ed: Stopping the Medicare Fraud Gusher

All eyes are on the BP gusher in the Gulf, spewing pollution over the shoreline, but there’s another big leak that will do even more damage to our economy: the one in the Medicare well.

Ever since 1965, when Medicare was enacted, the federal Treasury has been hemorrhaging dollars. Previously, “10%” was quoted and re-quoted as the amount of fraud. More recently, Senator Tom Coburn (R-OK) alleged it to be 20%.

Like BP’s oil containment dome, previous efforts failed to plug the hole. Despite hundreds of millions of dollars shoveled into the Health Care Fraud and Abuse Control Program (HCFAC) by HIPAA (the Health Insurance Portability and Accountability Act), federal prosecutors say they need still more “resources” and “tools.”

Attorney General Eric Holder is looking for people to prosecute for both leaks—which will do nothing to stop the pollution.

Containment efforts in new Medicare rules include requiring doctors to “revalidate” their billing privileges periodically. They’ll have to show that their name, address, identifying numbers, and organizational status are exactly as registered. They’ll have to give Medicare access to their checking account by electronic funds transfer (EFT) so that it can make immediate “adjustments” in case of overpayment.

The Patient Protections and Affordable Care Act (“ObamaCare”) imposes additional screening requirements; some providers will have to be fingerprinted.

Ever-more aggressive private bounty hunters called Recovery Audit Contractors (RACs) are descending on doctors’ offices, dissecting claims and patients’ records, looking for a missing “bullet point” in the documentation, or an inaccurate digit in the billing code. ObamaCare increases the penalties for errors from $11,000 per item to $50,000. The government’s burden of proof, already light, has been further decreased. There is no need to prove any intent to defraud, or even to show that any money was ever collected.

Also, the definition of “fraud” is expanded to include “unnecessary” services, “ineffective” services, or those that don’t comply with Medicare requirements.

Prosecutors are making examples of “greedy providers.” Dr. Ronald Poulin of Virginia was smeared all over the pages of his local newspaper before being convicted of “fraud”—that previously would have been called billing errors. Pictures of his home were posted on the internet—a nice house, bought with decades of hard work, now seized, along with his cars, his bank accounts, his medical license, his reputation, and his liberty. He sits in jail awaiting assignment to a federal prison.

One less oncologist will be prescribing expensive chemotherapy to cancer patients—and there are other effects that we don’t see. Deterrence works. Trying to help sick people is becoming very dangerous.

But will these methods end the fraud? Dr. Kenneth Christman, a past president of the Association of American Physicians and Surgeons (AAPS) (www.aapsonline.org), states that the amount of fraud is actually 100%, because Medicare is a Ponzi scheme. Today’s soon-to-be-retiring Baby Boomers have been bilked as surely as Bernie Madoff’s investors were, and their “trust fund” is full of internal government IOUs that can be redeemed only by borrowing from a bigger sucker.

Leaving ultimate Medicare reform aside, can we eliminate true billing fraud? Eliminating doctors does eliminate billing—of all types, by those doctors. But organized crime is said to be moving in.

As Malcolm Sparrow pointed out in a book by that title, third-party payment is A License to Steal. Payment is made for a “clean claim,” not for a messy service. And despite the government’s legal advantages, it takes time to go through the process of destroying doctors. So here’s the overnight solution.

Make insurance fraud, like credit-card fraud, self-revealing. Do away with “assignment of benefits,” which means paying the “provider.” Mail all insurance payments to patients, in the form of a dual-payee check.

Dead or fictitious patients don’t cash checks. Real people who did not receive a worthwhile service generally do not pay for it.

Fire the RACs, and put prosecutors to work fighting real crime, not creating crimes from arcane codes. Restore the natural regulatory system of customers reading understandable bills. Don’t put medical dollars into a huge bank vault that criminals can open with computer codes, and the practice of medicine into a bureaucratic prison.

Prisons don’t stop leaks.

By: Jane M. Orient, M.D.


Jane M. Orient, M.D., Executive Director of Association of American Physicians and Surgeons, has been in solo practice of general internal medicine since 1981 and is a clinical lecturer in medicine at the University of Arizona College of Medicine. She received her undergraduate degrees in chemistry and mathematics from the University of Arizona, and her M.D. from Columbia University College of Physicians and Surgeons. She is the author of Sapira’s Art and Science of Bedside Diagnosis; the fourth edition has just been published by Lippincott, Williams & Wilkins. She also authored YOUR Doctor Is Not In: Healthy Skepticism about National Health Care, published by Crown. She is the executive director of the Association of American Physicians and Surgeons, a voice for patients’ and physicians’ independence since 1943. Complete curriculum vitae posted at www.drjaneorient.com. Additional information on health-related issues: www.aapsonline.orgwww.takebackmedicine.com. and

Dr. Orient’s position on Obama’s healthcare reform: “The Obama plan will increase individual health insurance costs, and if the federal government puts price controls on the premiums, the companies will simply have to go out of business. Obama makes promises, but the Plan will deliver higher costs, more hassles, fewer choices, less innovation, and less patient care.”

Friday, June 4, 2010

Patients with Stage II and Stage III Colon Cancer Treated with 5-FU-Based Adjuvant Therapy after 1995 Have Improved Overall Survival

(BUSINESS WIRE)--ASCO Abstract Number: 3616 - Patients with stage III colon cancer treated with 5-FU-based chemotherapy after complete surgical removal of their tumor after 1995 had improved overall survival with no change in time to recurrence compared to patients treated before 1995. In contrast, patients with stage II colon cancer treated after 1995 had longer time to recurrence and time from recurrence to death compared to those patients treated prior to 1995, according to Mayo Clinic and Gr Hospitalier Pitie-Salpetriere, Paris, researchers. They will present the study’s findings on June 4-8, 2010, at the 2010 American Society of Clinical Oncology Annual Meeting in Chicago.

“By combining information from 21 cancer treatment trials for patients with stage II and stage III colon cancer, our analysis determined that those patients treated after 1995 had improved overall survival,” says Dan Sargent, Ph.D., Mayo Clinic biostatistician, North Central Cancer Treatment Group (NCCTG) statistician and senior author on the study.

The analysis compared patient data from more than 18,000 patients with stage II and stage III colon cancer treated with 5-FU-based chemotherapy after their primary tumor had been surgically removed for the time period 1978-1995 versus 1996-2007.

“Patients with stage II colon cancer treated after 1995 had had longer time to recurrence, possibly due to improvements in surgery and pathology” says Dr. Sargent. “In addition, after 1995, both stage II and stage III colon cancer patients treated after surgery with the same 5-FU-based chemotherapy after surgery had improved overall survival. This finding provides evidence to support previous findings that access to new medical therapies introduced in the mid-1990s as well as the expanded use of surgery for patients recurrent disease have meaningfully improving overall survival for patients treated in this setting.”

The findings arise from analysis of combined data collected within an expanded database by the Adjuvant Colon Cancer End Points (ACCENT) Group, a consortium of scientists. The ACCENT database includes data from more than 33,500 patients from the United States, Canada, Australia and Europe. ACCENT, chaired by Dr. Sargent, is supported by the North Central Cancer Treatment Group.

Dr. Sargent conducted the analysis on the expanded database in concert with an international team of scientists participating in ACCENT including Qian Shi, Ph.D. and Brian Bot, from Mayo Clinic; Thierry Andre, M.D., Gr Hospitalier Pitie-Salpetriere; Greg Yothers, M.D., NSABP Statistical Center, Pittsburgh; Daniel Haller, M.D., Abramson Cancer Center, University of Pittsburgh; Eric Van Cutsem, M.D., Ph.D., University Hospital Gasthuisberg/Leuven; James Cassidy, M.D., Glasgow University; Jacqueline Benedetti, Ph.D., Fred Hutchinson Cancer Research Center, Seattle; and Michael O’Connell, M.D., National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, NSABP Operations Center, Pittsburgh.

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Thursday, June 3, 2010

Medicare Meltdown Looming As Steep Medicare Cut Begins

/PRNewswire/ -- The U.S. Senate's failure to act before this week's 21 percent Medicare physician payment cut has put seniors' health care at grave risk. A new American Medical Association (AMA) physician survey shows that many physicians are already limiting the number of Medicare patients they treat. The AMA today launched a multi-million dollar national advertising campaign, with ads on TV and radio and in newspapers, including The New York Times, USAToday and The Wall Street Journal.

"The Senate has turned its back on our nation's seniors and the physicians who care for them by leaving for vacation and failing to stop a 21 percent Medicare cut before their self-imposed June 1 deadline," said AMA President J. James Rohack, M.D. "Today, the AMA is unveiling a new multi-million dollar ad campaign encouraging the public to contact their Senators and tell them to get back to work and fix Medicare now."

The 21 percent cut also hurts our nation's military families, as TRICARE rates are tied to Medicare. "It is sad and ironic that Senators raced home to celebrate Memorial Day without first voting to preserve health care for active duty military families," Dr. Rohack said.

Yesterday, the AMA received a call from Joan, a retired nurse, who was looking for a Maryland physician for her 72-year-old sister and could not find one who took Medicare. Both physician offices she called said that as of this June 1 they were no longer accepting new Medicare patients -- a real life example of how decisions made in Washington hurt real people.

Our new online survey of 9,000 physicians who care for Medicare patients confirms that seniors are already being hurt by Congress' mismanagement of the Medicare program. About one in five physicians (17%) say they have already been forced to limit the number of Medicare patients in their practice. Nearly one-third of primary care physicians (31%) have already been forced to take that action. The top two reasons physicians gave for these actions were the ongoing threat of future cuts and the fact that Medicare payment rates were already too low.

"Make no mistake: Physicians want to care for seniors and military families, but the chronic instability caused by the threat of future payment cuts has already taken its toll - and a 21 percent cut will make matters much worse," Dr. Rohack said.

"This is the third time this year that Congress has allowed a Medicare deadline to expire without action," Dr. Rohack said. "Each time Congress delays fixing the Medicare physician payment cut makes the problem worse and the price tag higher for the American taxpayer. Enough is enough. The Senate needs to fix the Medicare physician payment system for America's seniors once and for all."

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Wednesday, June 2, 2010

FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women

The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.

People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months.

“Due to its prevalence, osteoporosis is a serious concern to public health,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

The most common side effects reported with Prolia include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.

Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.

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