May 13, 2011
By Nausheen Shaikh and Leah Voigt*
Early HIV Therapy Sharply Curbs Transmission
People infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate, according to preliminary results from a large clinical trial released Thursday. Patients with HIV were 96% less likely to pass on the infection if they were taking antiretroviral drugs—a finding that is so overwhelming that it is likely to change the way American AIDS doctors treat patients and what treatment policies are adopted by the World Health Organization and other countries, said Dr. Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, which paid for the trial.
The data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early. There have been previous studies, notably among drug abusers in San Francisco and Vancouver, British Columbia, that concluded that starting patients on drugs immediately would stop them from infecting others.
Those studies led UNAIDS, the United Nations AIDS-fighting agency, to adopt "test and treat" as its goal last year; the policy encourages doctors to start people on treatment as soon as they test positive for HIV. However, this is the first evidence from a randomized clinical trial, the gold standard in medical research. AIDS prevention specialists not connected to the trial were enthusiastic.
"These results are phenomenal," said the director of the global health program at the University of California, Los Angeles, and the founder of the Center for AIDS Prevention Studies in San Francisco, CA. "It was a tough study to do, and I'm thrilled it came out this way." An AIDS specialist at the University of British Columbia whose work among Vancouver heroin addicts helped lead to the UNAIDS policy, called the result of 96% protection "as good as it gets."
The $73 million trial, known as HPTN 052, involved 1,763 couples in thirteen cities on four continents. One member of each couple was infected with HIV; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus. In the other half, the infected person started treatment only when his or her CD4 count—a measure of the immune system's strength—dropped below 250 per cubic millimeter.
Donald G. McNeil, Jr., Early HIV Therapy Sharply Curbs Transmission, New York Times (May 12, 2011).
New Fellowships Open in Addiction Medicine
Ten centers across the country have launched newly accredited fellowships in addiction medicine, according to the American Board of Addiction Medicine Foundation (ABAM). The one- or two-year graduate fellowship programs are designed to evaluate and treat patients with substance use disorders, behavioral addictions, and co-occurring psychiatric disorders, according to a release from the Addiction Institute of New York at St. Luke's and Roosevelt Hospitals, one of the first programs to be accredited.
Programs will be accredited on an annual basis by ABAM, its director of operations said. The first programs will begin this summer, with an initial crop of accredited addiction medicine fellows graduating in July 2012.
Some of the fellowship programs had been in place prior to accreditation, ABAM said, but they will now be held to a set of educational standards determined by an oversight committee. The latter will be chaired by a physician at the University of Buffalo, in New York, another center to have its addiction medicine fellowship accredited.
Physician training in addiction medicine is lacking, according to an ABAM release. Among the nation's 8,890 residency programs, none are dedicated to this field, and courses on addiction medicine are rarely taught in medical school.
Kristina Fiore, New Fellowships Open in Addiction Medicine, MedPage Today (May 12, 2011).
States Eye Public Access to More Doctor Disciplinary Records
A long-running push for increased transparency in the medical profession has led medical boards nationwide to release more information about physicians' professional and disciplinary history online during the last fifteen years. Even so, exactly what is publicly available—both to consumers seeking information online and families inquiring about a specific physician or complaint—varies greatly. States are hearing from consumers that not enough information is available or easily accessible.
So at least five states have recently passed or are considering legislation that would create more transparency, particularly regarding physician disciplinary records and procedures. The measures would release more physician information, make that information easier for consumers to get, and provide quicker responses on requests to investigate physicians.
Most medical licensing boards require physicians to report information such as liability settlements and criminal convictions, but individual boards decide what is reported on their public websites, said the president of the Federation of State Medical Boards.
Carolyne Krupa, States Eye Public Access to More Doctor Disciplinary Records, Am. Med. News (May 9, 2011).
FDA OKs First Microinjection Flu Vaccine
The U.S. Food and Drug Administration has approved the first influenza vaccine administered through a novel intradermal microinjection.
The Fluzone Intradermal vaccine is injected through an ultra-fine, 0.6 inch needle that is 90% shorter than most intramuscular flu vaccine needles, according to a statement from manufacturer Sanofi Pasteur. The vaccine works by generating an immune response from dendritic cells in the skin, according to the statement.
The Fluzone Intradermal vaccine is indicated for adult patients (ages eighteen to sixty-four) for the subtype A and type B influenza virus, and consists of a 0.5 mL or 0.1 mL, prefilled dosage with 15 mcg and
9 mcg of hemagglutinin, respectively, per strain of influenza.
Approval was based on phase three clinical trial data of 4,276 adults randomized to receive Fluzone via intradermal or intramuscular routes. Those in the intradermal group had a similar immunologic response to those in the intramuscular group, according to Sanofi Pasteur.
Cole Petrochko, FDA OKs First Microinjection Flu Vaccine, MedPage Today (May 11, 2011).
Payment for On-Call Coverage Becoming More Common
A growing percentage of physicians get some form of payment for providing on-call coverage, according to a report issued April 20, 2011, by the Medical Group Management Association (MGMA). Hospitals have had a harder time securing on-call coverage during the past few years, and the number of physicians receiving compensation for the service grew from 59% in 2009, to 65% in 2010.
"Physicians want to be compensated for call, and your younger, newer physicians are much more tuned into that than older physicians," said an independent consultant with MGMA Healthcare Consulting Group in Englewood, CO. "Physicians realize the value of their time and services and are negotiating compensation for on-call coverage."
How physicians are compensated for on-call coverage shifted slightly. A daily stipend was the most common form of payment, with 35% of physicians providing call coverage paid this way in 2010 compared with 33% in 2009. But more are being paid annually. An additional 21% received annual pay in 2010, an increase from 14% in 2009. About 6% were paid by the hour in 2010, down from 8% in 2009.
Victoria Stagg Elliott, Payment for On-Call Coverage Becoming More Common, Am. Med. News (May 9, 2011).
FDA Panel Discusses Ethics of Pediatric Drug Trials
A panel of pediatricians and pediatric ethicists met Wednesday to discuss the ethically complicated issue of testing new drugs in children. The Pediatric Ethics Subcommittee of the U.S. Food and Drug Administration's (FDA's) Pediatric Advisory Committee debated whether administering smaller-than-normal doses of investigational drugs to children as part of the early part of FDA review is ethical. Their conclusion: yes, in many cases.
During clinical drug development, large numbers of molecules are developed to identify the most promising candidates for further development. Those molecules are tested in vitro, then eventually in animals, and then generally a single molecule is tested in healthy human volunteers. But before human studies can begin, drug companies must submit an investigational new drug (IND) application to FDA outlining their plan to test whether the drug is reasonably safe in humans.
Those studies often involve giving a small dose of the drug to determine how it is metabolized in kids, provide information on how the drug works in the human body, or to select the most appropriate candidates in whom the drug might work best. Those early studies are not meant to provide any therapeutic benefit, which creates an ethical dilemma, especially when kids are involved.
Is it ethical to test a potentially risky investigational drug in children when no benefit is expected? Under FDA regulations, children cannot be enrolled in early exploratory trials unless there is only a "minimal risk" or a "minor increase over minimal risk" for harm. But administering an investigational drug to kids is generally not considered "minimal risk," so the caveat is that children with certain diseases or disorders can be enrolled in the early dosing trials if the research is "likely to yield generalizable knowledge about the subjects' disorder or condition that is of vital importance for the understanding or amelioration of the subjects' disorder or condition."
And panelists at Wednesday's meeting agreed that it would likely present no more than a minor increase over minimal risk to enroll kids with a disease or condition into an exploratory trial testing a small dose of the investigational drug to treat their given disease or condition. However, if the same trial was run on healthy kids, the issue gets more complicated, the panelists said.
For instance, if children with cancer are included in an exploratory trial testing an investigational cancer drug, they will not get an immediate benefit from the drug—the dose is too small and that is not the point of that particular trial. But they might benefit down the road if the drug is approved as a treatment for their specific type of cancer. But a healthy child is unlikely to benefit from that drug.
Emily P. Walker, FDA Panel Discusses Ethics of Pediatric Drug Trials, MedPage Today (May 11, 2011).
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 Nausheen Shaikh, JD Candidate (University of Southern California-Berkeley School of Law), and Leah Voigt, Esquire (Spectrum Health, Grand Rapids, MI), for providing this week's update.