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Teaching Hospital Update - March 22-26, 2010


Email Alert

By Leah Voigt*

March 26, 2010

Primary Care Shortage Could Crimp Overhaul

For all the changes put in motion by today's historic vote passing healthcare overhaul, an expansion of coverage for tens of million of uninsured people raises a really big question: Who will take care of them all? It's already tough to find a primary care doctor in many parts of the country.

Look no further than Massachusetts, where insurance coverage is as close to universal as any place in the United States, for a hint of the potential for trouble. Less than half of internists in the state (44%) are accepting new patients, according to data collected by the Massachusetts Medical Society last year. The average wait time for new patients to get an appointment? Forty-four days.

An annual event that foretells the future specialties of new doctors shows there is no quick fix coming. Thursday, March 18, was "match day," when seniors at American medical schools got matched with residency slots around the country. Lucrative specialties, such as radiology and dermatology, have been in high demand for years. Primary care, not so much. The National Resident Matching Program touted the rise this year in students matched to family care programs. But others noted that the increase--nine percentage points--still leaves a lot of growing room, especially considering the number of patients expected to seek new care because of reform.

Of 2,608 primary care training slots available--seventy-three more than last year--fewer than half were filled by American medical school seniors. "This won't make up for the shortfall, and there is definitely a shortfall in family medicine," said Dr. Lori Heim, president of the American Academy of Family Physicians.

Even so, she remains optimistic, "We have a start, now we need to build on it." Heim says the uptick might be due to all the talk about healthcare reform recently, from the media to lawmakers, and even President Barack Obama. "The debate has really highlighted family medicine and primary care, and demonstrated that people value that relationship between doctors and the community, and what primary care brings to the health care system," she told us.

Maggie Mertens, Primary Care Shortage Could Crimp Overhaul, Kaiser Health News (Mar. 22, 2010).

ReGen Device Reasonably Effective, But Better Evidence Needed, FDA Panel Says

The manufacturer of a medical device used to treat knee injuries provided the U.S. Food and Drug Administration (FDA) with enough evidence to show that it is reasonably effective, but issues remain regarding the strength of that evidence, an FDA advisory panel said on Tuesday. According to FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, device maker ReGen Biologics Inc. showed its Menaflex device was "reasonably effective" when compared with other similar devices that are already on the market. Menaflex is a collagen scaffold or CS device for meniscal repair, regulated within the generic type of device known as surgical mesh. The panel did not vote on any recommendations to give the FDA.

Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, told reporters after the meeting that the FDA would consider the feedback from the panel and make a final decision about the product's marketing clearance "in the next few weeks." The device was cleared for marketing under FDA's 510(k) clearance process, under which most devices reach the U.S. market, in 2008. Yet in a 2009 report, FDA found that it did not follow established processes, procedures, and practices in its premarket review and 2008 marketing clearance of Menaflex.

Prior to FDA's clearance of the Menaflex product in 2008, an FDA advisory panel was convened to discuss the device. In the 2009 FDA report, the FDA said that review of a 510(k) submission by an advisory panel "is highly unusual, albeit not unheard of." Such panel review is more typical with a premarket approval for a device.

Nathaniel Weixel, ReGen Device Reasonably Effective, But Better Evidence Needed, FDA Panel Says, BNA's Health Care Daily Report (Mar. 24, 2010) (note: registration is required to view this content).

Kidney Paired Donations May Expand Under Pilot Program

The Organ Procurement and Transplantation Network (OPTN) in February selected five organizations that work with more than eighty transplant centers to help test a nationwide kidney paired donation system. The pilot project could result in an additional 1,000 live-donor kidney transplants a year.

The United Network for Organ Sharing (UNOS) operates OPTN, which sets the country's organ transplant policy. "We think [the pilot] is going to be part of the solution to the organ shortage in this country," said John Friedewald, MD, chair of the OPTN/UNOS Kidney Paired Donation Workgroup. "We won't address the entire gap, but it's a good start." An added 1,000 live-donor kidney transplants a year would represent a 17% increase from the 5,749 such transplants performed in 2009. Another 9,653 transplants were performed last year using kidneys from deceased donors. As of March 19, 83,715 U.S. patients were awaiting a kidney transplant.

Often, patients in need of kidneys are able to find willing donors, but those donors are not histocompatible. A kidney-paired donation matches one incompatible donor-recipient pair to another pair to enable an exchange. Hundreds of such transplants have been performed since 2000. Sometimes transplant centers are able to arrange an extended chain of exchanges, such as a ten-transplant chain spanning four states and performed in July 2007. That exchange was coordinated by the Alliance for Paired Donation, a Maumee, OH, organization selected to take part in the UNOS national pilot project. Other organizations participating in the pilot are Johns Hopkins Hospital in Maryland, the New England Program for Kidney Exchange in Massachusetts, the Ronald Reagan University of California Los Angeles Medical Center, and the California Pacific Medical Center.

Kevin B. O'Reilly, Kidney Paired Donations May Expand Under Pilot Program, Am. Med. News (Mar. 19, 2010).

New Report Examines H1N1 Flu and Pregnancy

Delays in seeking and obtaining appropriate care for the H1N1 pandemic flu may have played a role in the rapid clinical decline of several pregnant and postpartum women in New York City last year, the Centers for Disease Control and Prevention (CDC) said recently. A case series of seventeen women with severe H1N1 disease showed that few were treated quickly with oseltamivir, and only one had been vaccinated against the pandemic flu, the CDC reported in today's issue of the Morbidity and Mortality Weekly Report.

The report is the third recently to examine how the H1N1 pandemic flu affected pregnant and postpartum women. The current CDC case series and the earlier cohort study have some overlap: nine women included in the May-June cohort are also in this case series, as well as eight who were diagnosed and treated later. The difference is that the cohort study compared all pregnant or recently postpartum women with the flu to non-pregnant women with the flu. The current analysis looks only at characteristics of pregnant women with severe disease.

"Severe disease" was defined as laboratory-confirmed H1N1 flu, leading to admission to an intensive care unit or death, among women who were either pregnant or had given birth within six weeks. All told, sixteen pregnant women in 2009 met the definition, along with one woman who was admitted to the intensive care unit (ICU) within two weeks of delivery. The researchers found that five women had risk factors for severe influenza complications other than pregnancy, including one patient with asthma and cardiovascular disease (diagnosed after death) and four patients with sickle cell disease, asthma, seizure disorder, and diabetes, respectively. Only one had received the H1N1 vaccine. In addition, six of the eight live infants were admitted to a neonatal ICU.

The case series "highlights some delays in pregnant women seeking care and obtaining appropriate diagnosis and treatment," the CDC said, despite "extensive outreach" to the public and healthcare providers. Some of the factors in those delays included rapid diagnostic tests that produced false-negative results, and failure to take oseltamivir as prescribed, the researchers said. The researchers noted that methods of case ascertainment varied during the year, which might mean the various cases are not comparable. Furthermore, active case finding was limited, which might have led to an under-ascertainment of cases. Finally, they noted that the vaccine against the pandemic flu was not available until October, and vaccination status for most of the women was not known.

Michael Smith, New Report Examines H1N1 Flu and Pregnancy, MedPage Today (Mar. 25, 2010).

After Healthcare Reform Bill's Final Passage in House, Drug Industry Anticipates More Work Ahead

While praising individual provisions of the final healthcare overhaul bill, pharmaceutical industry groups said the legislation the House approved late Sunday night is an imperfect measure, and they will continue to work on issues such as a new payment advisory board affecting Medicare policy, pay-for-delay patent settlements, and generic competition with biologic drugs. The associations' interests vary, but several said they expect to continue to work on reform efforts even after President Obama signs the final package into law.

The Pharmaceutical Research and Manufacturers of America (PhRMA), for example, said Sunday that it supports the House passage of the legislation (H.R. 3590) and an accompanying reconciliation bill (H.R. 4872) because "existing barriers to quality health care simply are not acceptable." However, the industry association criticized the creation of an Independent Payment Advisory Board (IPAB) because of its "overly broad powers" and because it is not an elected body.

In a statement, PhRMA said IPAB "could enact sweeping Medicare changes without action by Congress and would not be subject to judicial or administrative review. We look forward to working with Congress to address these concerns and to identify ways to contain medical costs without creating new barriers to quality health care." IPAB would prepare proposals to slow Medicare spending, and its proposals would be implemented unless Congress takes action.

Meanwhile, the Generic Pharmaceutical Association said Sunday that it supports a key provision in the healthcare bill: closing the Medicare
Part D prescription drug benefit coverage gap, called the doughnut hole. Under the healthcare reform package, beneficiaries who are subject to the doughnut hole would receive rebates and discounts, and the gap gradually would close in the coming years.

Jessica Coomes, After Reform Bill's Final Passage in House, Drug Industry Anticipates More Work Ahead, BNA's Health Care Daily Report (Mar. 23, 2010) (note: registration is required to view this content).

Research Offers Clue Into How Hearts Can Regenerate in Some Species

Doctors who have treated heart attack patients with injections of stem cells have had little success so far in making the heart regenerate its stricken tissues. Researchers have now discovered that in nature, hearts are regenerated in a quite different way, one that does not depend on stem cells. The finding may explain the lack of clinical success with the stem cells and suggest new approaches.

Humans can regenerate the liver but cannot replace limbs and other organs. But fish and amphibians can grow new fins or limbs, and the zebra fish, which has been adopted by researchers as a laboratory organism, can even regenerate its heart after the bottom fifth has been lopped off. The fish are sluggish for a while but re-grow the missing part of their heart in a month. The human heart does have a very limited capacity to generate new heart muscle cells--about half the cells are replaced over the course of a person's lifetime. But this regenerative capacity does not accelerate in response to a heart attack. Instead, the damaged cells are replaced by scar tissue, which does not contract.

Researchers assumed that the situation is different in the zebra fish because of stem cells that could generate more heart muscle cells after injury. A 2006 report by Duke University researchers offered confirmation that stem cells are the source of the repair process. Stem cells are general purpose cells that generate the mature, functional cells of the body. But two independent reports in the recent issue of the journal Nature contradict the stem cell idea, reporting that the mature heart muscle cells are the principal source for regenerating the zebra fish heart.

One of the two reports is from a team led by researchers at the Center for Regenerative Medicine in Barcelona, Spain. The Barcelona team genetically engineered the zebra fish's heart muscle cells so that when they proliferated they would synthesize a fluorescent green protein. After cutting off the bottom of the heart and letting it regenerate, they found that all the cells in the new part of the heart glowed green, proving that existing heart muscle cells were the principal or only source of the new tissue. Nature's recipe for regeneration, at least in this case, is evidently to take the mature cells and walk them back in development to a stemlike state. The second step is for these stem-like heart muscle cells to grow and divide, generating replacement tissue. This contrasts with the assumption that tissues would be generated from stem cells that differentiate, or mature, into adult cells.

Zebra fish and mammals are separated by a long evolutionary distance and yet, surprisingly, the first step in the regeneration process, the dedifferentiation of heart muscle cells, occurs in mammals as well. In zebra fish, the structure of the muscle fiber disintegrates as the cells dedifferentiate. The same process can be seen after injury in the hearts of mice, rats, and dogs, researchers said, but the cells get stuck in the second process, that of proliferating to form new tissue.

Charles Murry, an expert on heart cell biology at the University of Washington in Seattle, said the two reports raised the tantalizing question of why human hearts could not complete the regeneration process. In human hearts, too, Dr. Murry said, the muscle cells dedifferentiate after injury and double up their DNA, a necessary precursor to cell division. But they do not finish the process, for reasons that are so far unknown.

Nicholas Wade, Research Offers Clue Into How Hearts Can Regenerate in Some Species, N.Y. TIMES (Mar. 24, 2010).

AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.

*We would like to thank Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.

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