In the News for the Week of 1-16-07
- Amniotic stem cells show potential for research
- Preventive care lags in overall improvement of U.S. health care
- Drug firms agree to pay FDA 30% more for safety reviews
- AHRQ releases osteoarthritis drug guides
- Annals of Internal Medicine:
- Growth hormone doesn't prevent or reverse aging changes
- Survival of people with HIV improved in Danish study
- Blood test may predict future heart problems
- Part D updates and clarifications
- Physician groups announce principles for reform
New research suggests that stem cells from amniotic fluid may hold potential for regenerative medicine similar to that of embryonic stem cells. Scientists extracted the cells from discarded samples of amniotic fluid from amniocentesis and converted them into several different tissue-cell types, including brain, liver and bone.
Researchers reported that amniotic cells could have advantages over embryonic and adult cells because they are readily accessible, replicate rapidly in culture and can be directed toward differentiated cell types. The research was conducted over seven years at Wake Forest University and Harvard University and published in the Jan. 7 issue of Nature Biotechnology.
It is not yet clear how many cell types can be developed from the amniotic stem cells and preliminary tests in patients are still years away, reported the Jan. 8 Philadelphia Inquirer. Embryonic cell researchers hope to start testing patients next year, according to the Jan. 11 Washington Post.
Existing federal regulations tightly limit federal funding for embryonic stem cell research. However, Congress is currently debating legislation to expand funding and create federal ethics rules for embryonic stem cell research. The pending legislation was approved by the House on Thursday and is expected to pass the Senate next month. The President is likely to veto the legislation and it is unclear whether Congress will be able to override his veto, the Washington Post said.
The Philadelphia Inquirer is online.
Nature Biotechnology is online.
The Washington Post is online.
The overall quality of U.S. health care is improving, but providers are missing opportunities for preventive care, according to two new government reports. The 2006 National Healthcare Quality Report and National Healthcare Disparities Report both found that the use of proven prevention strategies lags behind other areas of health care.
The reports, issued by the Agency for Healthcare Research and Quality (AHRQ), revealed that:
- Only about 52% of adults reported receiving recommended colorectal cancer screenings.
- Fewer than half of obese adults reported being counseled about diet by a health care professional.
- Only 48% of adults with diabetes received all three recommended screenings-blood sugar tests, foot exams and eye exams.
There was a 3.1% increase in overall quality of care (evaluated by 40 core standards), matching results for the past two years. The congressionally mandated annual reports measure health care quality and disparities in four key areas: effectiveness, patient safety, timeliness of care and patient centeredness.
The reports found the greatest quality gains, of almost 8%, in hospitals. Marked improvements were seen in care for heart attack and pneumonia patients and for steps taken to avoid surgical complications. AHRQ officials attributed the improvements to CMS initiatives, such as the Hospital Quality Alliance.
The AHRQ news release is online.
The drug industry has agreed to pay the government about 30% more for product safety reviews, as well as $6.2 million for a new program to review television commercials, the FDA said last week.
The increase, which would boost total user fees to about $399 million (including the new TV ad program), is awaiting Congressional approval. Under the Prescription Drug User Fee Act (PDUFA), a new fee schedule is required every five years, with the average yearly increase at about 14%.
Monies from the fee increase will be used as follows:
- $29.3 million to review the safety of drugs already on the market, including hiring 82 new staff.
- $20 million to cover drug review workload increases
- $17.7 million to adjust for inflation and support staff salary and benefits increases.
- $11.7 million to cover the cost of moving and higher rent for a new facility.
- $4.6 million for 20 employees to expand reviewer guidance and develop guidelines for industry on clinical trial design.
- $4 million for technology upgrades to improve drug reviews.
The $6.25 million in new fees for TV ad reviews will be used to hire 27 new staff, the FDA said. These fees aren't funded under PDUFA, but are assessed and collected separately and only from those companies that intend to seek review of TV ads. By law, such ads must contain information about a drug's risks, and must not be misleading.
Under the PDUFA, companies pay fees when they apply for FDA review of new drugs, with amounts depending on the product. In 2005, industry user fees comprised 56% of the FDA's annual budget for drug reviews and expert staff, compared with 53% in 2004 and 35% in 1995, said the Jan. 12 Philadelphia Inquirer. The user-fee system was created in 1992.
The FDA's Federal Register Notice is online.
The Philadelphia Inquirer is online.
The FDA recently approved the first generic version of ondansetron (GlaxoSmithKline's Zofran), which prevents nausea and vomiting after surgery, radiotherapy and cancer chemotherapy. Ondansetron was the 20th highest selling brand-name drug in the U.S. in 2005.
The approval covers ondansetron tablets, orally disintegrating tablets and the oral solution, ondansetron hydrochloride.
The FDA news release is online.
The FDA has issued more than 1,000 letters to drug manufacturers recommending that they reevaluate pharmacokinetic studies conducted by the Canadian testing company MDS Pharma Services.
Agency officials have identified 217 generic drugs that included MDS studies in their applications for FDA approval, reported the Jan. 10 Washington Post. The number of affected brand-name drugs is unknown, and the FDA is asking all drug manufacturers who submitted applications between 2000 and 2004 to identify and reevaluate any MDS studies.
Affected companies will have six months to validate the study data through audits, new analyses or repeat testing. According to the FDA, there is no evidence of problems with the quality, purity or potency of any of the drugs, and no drugs are being removed from the market, although the approval process of some drugs could be slowed.
The FDA action is a result of two inspections of MDS facilities which revealed problems with test validity and accuracy. The company agreed to audit its testing, but failed to identify and fix the problems to the FDA's satisfaction. MDS will now work to support its clients' independent audit activities, company officials told the Washington Post.
The Washington Post is online.
The FDA is online.
A pair of new guides released by the Agency for Healthcare Research and Quality (AHRQ) use plain language to give patients and clinicians the latest scientific evidence on the use of osteoarthritis medications. The new guides, the first in a series on various health topics developed through AHRQ's Effective Health Care (EHC) program, draw on a recent EHC review of 360 published studies about osteoarthritis pain medications.
The guide for clinicians, Choosing Non-Opioid Analgesics for Osteoarthritis, summarizes scientific evidence that applies to the drugs' benefits and risks. The consumer guide, titled Choosing Pain Medication for Osteoarthritis, summarizes the evidence on both prescription and over-the-counter drugs. It includes information on effectiveness, cost, and potential side effects for non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, acetaminophen, and others.
Future EHC guides will summarize the effectiveness of other important health interventions, including the use of second-generation antidepressants, treatments for low-bone density, and oral medications used for type 2 diabetes.
The clinician guide is available online.
The consumer guide is available online.
The following articles appear in the Jan. 16 issue of Annals of Internal Medicine. This issue also includes a review which found that narcotics are often prescribed for back pain although efficacy data are poor and chances for abuse high. The full text is available to College members and subscribers online.
- Growth hormone doesn't prevent or reverse changes of aging in healthy elderly people A review of published data on use of human growth hormone by healthy elderly people found that the synthetic hormone was associated with small changes in body composition but not in body weight or other clinically important outcomes. People who took GH had increased rates of unhealthy side effects such as soft tissue swelling, joint pain, carpal tunnel syndrome, and, in men, development of abnormally large mammary glands, and were also somewhat more likely to develop diabetes. Review authors said that although GH has been widely publicized as an anti-aging therapy, there is little evidence of clinically relevant outcomes, and it is associated with high rates of adverse events. They concluded that on the basis of available evidence, GH cannot be recommended for use among the healthy elderly.
- In Danish study, survival of people with HIV improved in recent years. A study of nearly 4,000 HIV-infected people in Denmark, matched with about 380,000 people who were not infected, found that people diagnosed with HIV infection between 1995-2005 had a shorter life expectancy (20 years beyond age 25) than the general population (51 years beyond age 25). However, the life expectancy of a 25-year-old person diagnosed with HIV infection has improved (33 years beyond age 25) for those diagnosed since 2000, when highly active antiretroviral therapy (HAART) became standard treatment. These findings show that HAART has transformed HIV infection into a chronic disease with a long, but not normal, lifespan.
A blood test used to evaluate heart failure may also help predict the risk of subsequent heart complications and death in people with coronary heart disease, a new study found.
The prospective cohort study examined 987 Californians with stable coronary heart disease to determine whether plasma levels of amino terminal fragment of the prohormone brain-type natriuretic peptide (NT-proBNP) predicted cardiovascular events or death independent of other prognostic tests. Blood was drawn and urine samples taken, and patients underwent an echocardiogram before and after a treadmill test. Patients were followed for a mean of 3.7 years.
About 26% of participants died or had a CV event. The overall event and death rate increased with each quartile increase of NT-proBNP, as did risk for each of the individual events in the composite outcome. Those with NT-proBNP concentrations in the highest quartile had nearly eight times the increased rate of CV events or death of those in the lowest quartile. The study was published in the Jan. 10 Journal of the American Medical Association.
Although NT-proBN has potential to guide treatment, clinical trial evidence should first be required to demonstrate that matching a treatment strategy to an elevated NT-proBN level improves clinical outcomes, said an accompanying editorial.
The blood test used to determine NT-proBNP level costs less than $50 and is used to help discern whether people in the emergency room with shortness of breath have worsening heart failure, said the Jan. 10 Philadelphia Inquirer.
The JAMA abstract is online.
The Philadelphia Inquirer is online.
CMS recently provided the following information and clarifications regarding the Part D drug benefit implementation:
Prior authorizations and exceptions approved by a drug plan in 2006 are expected to continue in 2007 if the beneficiary remains in the same plan and the expiration date (if applicable) hasn't occurred by Dec. 31, 2006. If the beneficiary changes plans, but enrolls in a plan administered by the same sponsor, CMS is encouraging the Part D plan to follow the same policy.
Authorizations and exceptions approved by a drug plan in 2006 will not be continued in 2007 for beneficiaries who change plans and enroll in a new plan offered by a different sponsor. These beneficiaries will receive the benefit of a required transition period during which they will continue to receive their currently prescribed medications.
Beneficiaries who present a pharmacist with a physician's prescription for a drug that is not covered by their plan or are asked to pay a different cost than they believe is required should either receive or be referred to a copy of the "Medicare Prescription Drug Coverage and Your Rights" notice, according to CMS regulations. This notice outlines the beneficiary's rights for a written explanation from the drug plan regarding the transaction and the procedure to submit an appeal. According to CMS, these notices are frequently not being distributed or referred to by pharmacists. Physicians can choose to supply the standard notice to patients to make sure they are aware of their rights. The notice is available online.
All Part D drug plans have been notified by CMS that they cannot require a physician's DEA number for non-controlled substance prescriptions.
Any problems regarding the Part D benefit or plan that cannot be resolved through contact with the drug plan can be relayed directly to CMS by email at PRIT@cms.hhs.gov. Assistance is also available through the ACP helpline at (800) 338-2746 ext. 4535. In addition, ACP provides basic, practical information on the Part D benefit and additional links to patient-oriented materials on the Practice Management Center's Part D Web site.
ACP and nine other leading physician associations, which together encompass the majority of the nation's practicing physicians, recently declared a list of principles for reforming the U.S. health care system. The coalition hopes to trigger bipartisan Congressional action to cover the uninsured.
The Principles For Reform of the U.S. Health Care System, released Jan. 12, call for the following changes:
- Health care coverage for all to ensure quality of care and to improve the health status of Americans, and appropriate health care to all people within the U.S. borders, without unreasonable financial barriers to care
- Catastrophic health coverage to protect all individuals and families from financial ruin
- Improvement of health care quality and safety as the goal of all health interventions
- Respect for the ethical imperative of providing health care to individuals, responsible stewardship of community resources, and the importance of personal health responsibility
- A shared public/private cooperative effort to finance health services, and a system which will allow individuals/employers to purchase additional services or insurance
- Cost management by all stakeholders and less complicated administrative systems to reduce costs, create a more efficient health care system and maximize funding for health care services
- Sufficient funding for public health and essential medical services as well as research, medical education and comprehensive health information technology infrastructure and implementation
- Comprehensive medical liability reform to ensure access to quality health care.
More information is on the ACP Web site.
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Copyright 2007 by the American College of Physicians.
A 25-year-old woman comes for a preconception evaluation. She has a history of hypertension that is well controlled with lisinopril. Medical history is otherwise unremarkable. Following a physical exam, lab studies, and an electrocardiogram, what medication adjustments should be made before this patient proceeds with pregnancy?
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