Researchers Study New Drug Combinations to Treat Childhood Leukemia

Scientists from the Barbara Ann Karmanos Cancer Institute in Detroit presented data today at the American Association for Cancer Research's 100th Annual Meeting 2009 that could potentially provide a brighter future for children who suffer from a more deadly form of acute leukemia.

Yubin Ge and Chengzhi Xie presented work at the conference revealing that a combination of FDA-approved drugs works synergistically to help children with acute myeloid leukemia (AML). Ge is an assistant professor at the Karmanos Cancer Institute and at the Wayne State University School of Medicine's Department of Pediatrics. Xie is a postdoctoral fellow with the Developmental Therapeutics Program at Karmanos Cancer Institute and Wayne State University School of Medicine. He also is a lecturer with the College of Life Science at Jilin University in Changchun, China.

AML, which originates in bone marrow, accounts for one-fourth of acute leukemia in children and is responsible for more than half of the leukemia deaths in this population. Approximately 600 children are diagnosed with AML each year, according to Ge and presently there is no effective drug treatment for those children should they relapse.

"Right now, we are at a bottleneck," Ge says. "We really want to find a better treatment for those relapsed cases."

Ge and fellow researchers considered drugs that are already FDA-approved to help fight AML. Resistance among patients to FDA-approved cytarabine is a major cause of treatment failure in AML. Scientists considered clofarabine, approved by the FDA in 2004, and paired it with valproic acid (VPA), typically used to treat epilepsy. They found the two drugs worked together to dramatically stimulate cell death.

"We considered an old drug for a new use," Ge says. "It looks like the increased drug activity or synergy is not due to the transport or delivery of clofarabine, but to enhanced cell death. We were so pleased with the results."

AML afflicts mostly adults -- about 10,000 new cases each year -- and strikes older children. Acute lymphoblastic leukemia usually affects children between the ages of 2 to 5 and is generally easier to treat. Treatment advancements for AML, however, have been less successful.

Ge says that researchers at Karmanos discovered the synergy between VPA and clofarabine only a few months ago, though departmental research has spanned some 15 years in the field of treating childhood leukemias. The current research represents a unique partnership between Ge, his Karmanos colleagues, and Dr. Jeffrey Taub, M.D., a pediatric oncologist at Children's Hospital of Michigan, also in Detroit.

Ge expects that their findings will move into the clinical phase in the next few years. St. Jude Children's Research Hospital in Memphis, Tenn. Is now conducting its own clinical drug trial studying the combined effects of VPA and cytarabine to treat newly diagnosed AML patients 21 years old and younger.

"This is truly translational research," Ge says. "We really want to translate what we do in the laboratory to the clinic and hopefully save more lives."

Located in mid-town Detroit, Mich., the Barbara Ann Karmanos Cancer Institute is one of 40 National Cancer Institute-designated comprehensive cancer centers in the United States. Caring for more than 6,000 new patients annually on a budget of $216 million, conducting more than 700 cancer-specific scientific investigation programs and clinical trials, the Karmanos Cancer Institute is among the nation's best cancer centers.

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State Medicaid Policies Impeding Access to Effective Drug for Alcohol Abuse

Many states could more effectively address the huge financial and societal burden of alcohol abuse by changing policies that may be inadvertently impeding access to an inexpensive prescription drug known to reduce problem drinking. These findings appear in a new study in the online version of the journal, Health Services Research.

The study by researchers at the University of Wisconsin and Georgetown University examined how state efforts to control spending on Medicaid, the program that provides health care for low-income individuals and families, may be limiting the ability of physicians to treat alcohol addiction with a widely studied generic drug called naltrexone. The research was funded by the Robert Wood Johnson Foundation’s Substance Abuse Policy Research Program (SAPRP).

“States should be keen to quickly deal with this problem because today they are spending on average about $1 of every $7 of their revenues dealing with alcohol-related problems like child neglect and violent crime,” says Carolyn Heinrich, a professor of public affairs at the University of Wisconsin-Madison and the study’s lead author. “Naltrexone is certainly not a cure-all, but it can be a powerful therapy, it’s relatively inexpensive and states have the policy levers at hand to increase its availability to alcohol addicts.”

Evidence from clinical trials shows that naltrexone, which blocks a brain receptor associated with a craving for alcohol, makes it easier for alcoholics to stop drinking and stay sober even when the drug is used alone; that is, unaccompanied by counseling or other interventions.

“We know from extensive research that only about 6 percent of people diagnosed as alcohol dependent are getting medication during their treatment and about a third of those who do not get medication cite cost or insurance as the key barrier,” Heinrich says. “Revising certain state policies on prescription drugs is one way to address what is clearly a need for greater access to a clinically-proven and cost-effective treatment.”

Heinrich and her colleague Carolyn Hill, an assistant professor at Georgetown Public Policy Institute, found that treatment providers are more likely to prescribe naltrexone when states institute policies that encourage the use of generic drugs, include generics on their preferred drug lists and reduce drug costs for Medicaid beneficiaries. Conversely, they found naltrexone is less likely to be adopted in states whose policies allow managed care organizations to restrict access to pharmacy networks or limit prescriptions. Other policies that impede naltrexone’s use include restricting the use of Medicaid funds for substance abuse treatment and establishing restrictive Medicaid preferred drug lists.

State policies related to Medicaid prescription drug benefits are seen as critical to determining naltrexone’s availability because Medicaid funds and related block grants constitute the majority of spending, public or private, on substance abuse treatment. One reason for this dominant role is that most alcoholics tend to be poor and lacking in health insurance and thus are dependent on Medicaid for care.

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Marjiuana Alleged in Load of Cookies

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Video: Pain Medication in U.S. Nearly Doubles

An Associated Press analysis shows that pain medication use in the United States has nearly doubled. Meanwhile, physicians are facing increased scrutiny from federal drug agents looking to crack down on drug abusers.

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Vaccines Help Kick Drug Habits

A pair of new vaccines designed to combat cocaine and methamphetamine dependencies not only relieve addiction but also minimize withdrawal symptoms, according to study results presented by Baylor College of Medicine (BCM) researchers at the Annual Meeting of the College on Problems of Drug Dependence in Quebec City, Canada.

The vaccines stimulate the body to produce antibodies which then attack the drug while it is in the blood stream. This prevents the drug from reaching the brain and creating the reactions that contribute to dependency.

“These are therapeutic, not preventative, vaccines,” says lead investigator Thomas Kosten, Jay H. Waggoner Professor of Psychiatry & Behavioral Sciences at the Menninger Department of Psychiatry at BCM and research director of the Veteran Affairs national Substance Use Disorders Quality Enhancement Research Initiative. “They are meant for those who are already suffering from drug addiction.”

Kosten stresses that while the vaccines have been shown to help overcome drug addictions, they do not necessarily curb relapse.

“This is not a stand-alone treatment,” Kosten says. “There is a reason drugs were used in the first place, and that needs to be dealt with either through counseling or behavioral therapies.”
TA-CD, the cocaine vaccine, works through a series of injections over a three-month period. Study participants began to respond favorably to the vaccine after about a month. TA-CD has one more large scale human study scheduled before it is ready for the FDA approval process.

“The vaccine slowly decreases the amount of cocaine that reaches the brain,” Kosten says. “It’s a slow process, and patients do not go through any significant withdrawal symptoms.”

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Outsourcing to Biotechs Is the Answer for Many Pharma Companies' Development

Small, mid-sized and large pharmaceutical companies are turning to outsourcing to free up cash for more early-stage marketing endeavors, according to a new study from Cutting Edge Information.

Early-stage development and commercialization resources can be hard to come by, as most pharmaceutical executives can attest to. Cutting Edge Information's study found that companies that focus their limited early-stage resources on commercialization have a distinct advantage once their products reach the market.

"Uniting R&D and Marketing for Integrated Early-Stage Market Preparation" is Cutting Edge Information's latest study. The report reveals that pharmaceutical companies are looking towards the biotech sector to outsource development of new drugs. In doing so, the company can free up resources to market drugs currently in their pipelines.

"It is no secret that the top pharmaceutical products each year are backed by hundreds of millions in marketing dollars," says Elio Evangelista, research team leader at Cutting Edge Information."Pharma-biotech partnerships have become a more popular method for pharmaceutical companies to outsource drug development and fill pipeline gaps."

One profiled company is in favor of shrinking business unit departments and creating small internal teams to handle deals with small biotechs to outsource most of the early-stage pre-clinical work. The idea is based on the biotech industry's capability to develop innovative products morequickly than slow-moving, large pharmaceutical companies. The company invests almost as much in early-stage research as it would for an in-house compound, but it outsources the work to smaller, faster-moving biotechs, which assume some of the risk that the company would otherwise retain.

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Researchers Find Deadly Prescription Drug Effects Six Years Before FDA

Northwestern University's Charles Bennett, M.D., is a super sleuth of potentially deadly prescription drug reactions. He leads a national SWAT team of doctors called RADAR (Research on Adverse Drug Events and Reports) based out of Northwestern's Feinberg School of Medicine.

They swoop in to investigate early signs of trouble years before the Food and Drug Administration (FDA) takes notice.

A new study by Bennett, the A.C. Buehler professor in Economics and Aging at Northwestern's Feinberg School of Medicine, and a hematologist and oncologist at Northwestern Memorial Hospital, found RADAR identified serious drug reactions six years earlier than the FDA and drug companies.

RADAR's proactive safety efforts and reports also were much more comprehensive than those from the FDA or drug companies, according to the study. RADAR's reports provided doctors with important medical insights as well as guidance for prevention, diagnosis and treatment.
The study will be published in Archives of Internal Medicine.

Since Bennett launched RADAR in 1998, his research has resulted in black box warnings on billion dollar drugs like Plavix that may have saved thousands of lives. He has also provided guidance to help physicians more safely administer drugs. More than 100,000 people die each year from reactions to medications. The FDA is under attack for its passive and inefficient methods of learning about these problems.

Why is RADAR so nimble" Bennett's network includes hematologists and oncologists around the country and the world. His phone rings weekly with calls from concerned doctors alerting him to possible new trouble. After such a call, Bennett probes for clues that led to a life-threatening reaction to a drug. ‘What's the age and weight of the patient, x-rays, details of the physical exam and blood tests"' he'll ask. He'll canvas doctors to see if they've seen similar cases. If a vital piece of evidence is missing, Bennett even will track down a doctor at home on a Sunday and ask her to drive back to her office to check a chart. Then Bennett and his team fit all the puzzle pieces together to figure out what happened and how to prevent it in the future.

The new study also shows, however, that the FDA and drug companies were faster than RADAR to spread the word about serious adverse drug reactions. RADAR relies on publishing its studies in peer-reviewed medical journals, a process that takes longer than the FDA's warning letters to doctors and the drug companies' package inserts.

Thus, it's time for a formal collaboration between RADAR and the FDA to wed their strengths, said Bennett, who also is co-director for cancer control of the Robert H. Lurie Comprehensive Cancer Center.

"We need to work together as partners," Bennett says of the FDA. "Pharmaceutical side effects are one of the top five causes of death in this country. We want to move it out of the top five. This is the way to start that process and save thousands of lives."

Bennett envisions a formal partnership with the FDA in which he would share RADAR's investigations on safety issues, arrive at a joint insight on drug problems and have the FDA distribute the information to doctors.


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Pharmacists' Workload Contributes To Errors

High workloads for pharmacists increase the potential for medication errors, says a new study by University of Arizona College of Pharmacy researchers published in the May issue of the journal Medical Care.

The study was conducted by a team of researchers led by College of Pharmacy professor Daniel Malone, who is also a member of the Arizona Center for Education and Research on Therapeutics at the Critical Path Institute.

Researchers reviewed data submitted to insurance companies from 672 pharmacies in 18 metropolitan regions. The pharmacies filled an average of 18,000 prescriptions from January to March 2003, or 1,375 prescriptions per week. During that time, the average number of potentially harmful drug-drug interactions dispensed by each pharmacy was 32.1.

The pharmacies employed an average of 1.2 pharmacists for each hour the store was open, and each pharmacist filled an average of 14.1 prescriptions per hour. The risk of dispensing potentially harmful combinations of medications that could result in a drug interaction increased by 3 percent for each additional prescription filled per hour.

The study also found that computerized interaction alerts and telephone, Internet, and fax systems—which are intended to decrease pharmacist workload and increase the efficiency of prescription receipt and filling—also were associated with an increase in the number of prescriptions dispensed for medications that could interact.

“It appears that prescription volume is exceeding capacity and that automation and other pharmacy staffing may not sufficiently compensate for the increased pharmacist workload,” Malone says. “Additional research is needed to confirm and clarify this study, but our findings are consistent with other reports concerning workload and medication errors. We need to take a closer look at what we can do better in community pharmacies to reduce potentially dangerous interactions between dispensed medicines.”

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University Launches Study on Prescription Drug Addiction Treatment

The University of California, San Francisco (UCSF) is launching a new study to evaluate treatments for addiction to prescription painkillers and has openings for patients to enroll.

This is the first large-scale study to assess whether addiction to opioid painkillers, such as Vicodin and OxyContin, can effectively be treated with drug treatments currently used for heroin addiction.

The study is part of a national effort involving 11 clinical research centers to evaluate such therapies. Known as the Prescription Opiate Addiction Treatment Study, or POATS, it is being led by the National Drug Abuse Treatment Clinical Trials Network, under the National Institute of Drug Abuse (NIDA). UCSF is the only study site in Northern California.

The research is in response to the growing national problem of prescription drug abuse that has resulted in higher emergency room admissions and potentially devastating impacts on millions of Americans and their families, according to Stephen Dominy, MD, director of the Division of Substance Abuse and Addiction Medicine at San Francisco General Hospital Medical Center, who is co-leading the UCSF portion of the study.

“The abuse of prescription opiates has become a very serious problem in our society, but until now, there have been no large-scale studies to evaluate how to treat those addictions,” Dominy said. “This study hopes to assess whether current opiate dependence therapies are effective, as well as the role of counseling in treatment outcomes.”

An estimated 2.2 million Americans aged 12 or older start using prescription pain relievers each year for non-medical uses, surpassing the number of new marijuana users (2.1 million), according to the 2005 National Survey on Drug Use and Health. In that survey, more than 6 million Americans reported using prescription drugs for non-medical uses in the previous month, which is more than the number abusing cocaine, heroin, hallucinogens and inhalants, combined.

Those users, however, seem to fit a very different profile from traditional patients in heroin dependence programs, according to Yong Song, co-principal investigator for the UCSF site study and an assistant clinical professor of psychiatry in the UCSF School of Medicine. These users tend to be younger, he said, with fewer other dependency issues, such as alcohol or cocaine, and often come from a middle-class background.

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Teen Risk-Taking May Be Biologically Driven and Inevitable, Research Says

While the government spends billions of dollars on educational and prevention programs to persuade teens not to do things like smoke, drink or do drugs, a Temple University psychologist suggests that competing systems within the brain make adolescents more susceptible to engaging in risky or dangerous behavior, and that educational interventions alone are unlikely to be effective.

Laurence Steinberg, distinguished university professor and the Laura H. Carnell professor of psychology at Temple, outlines his argument in, “Risk Taking in Adolescence: New Perspectives from Brain and Behavioral Science,” in the April issue of the journal, Current Directions in Psychological Science.

“While it is probably not fair to say that none of the programs we have developed works, most of the educational efforts to persuade kids to not smoke or to not use drugs or alcohol, to engage in safe sex or to drive more safely have not been effective,” says Steinberg, director of the John D. and Catherine T. MacArthur Foundation Research Network on Adolescent Development and Juvenile Justice. “There is a program here or there that works, but, by and large, we have spent billions of dollars on initiatives that have not really had much of an impact.”



Steinberg says that over the past 10 years there has been a great deal of new research on adolescent brain development that he believes sheds light on why kids engage in risky and dangerous behavior, and why the educational programs or interventions that have been developed have not been especially effective.



According to Steinberg, heightened risk taking in adolescence is the result of competition between two very different brain systems, the socioemotional and cognitive-control networks, that are undergoing maturation during adolescence, but along very different timetables. During the adolescence, the socioemotional system becomes more assertive during puberty, while the cognitive-control system gains strength only gradually and over a longer period of time.
The socioemotional system, which processes social and emotional information, becomes very active during puberty allowing adolescents to become more easily aroused and experience more intense emotion, and to become more sensitive to social influence.



Conversely, says Steinberg, the cognitive-control system is the part of the brain that regulates behavior and makes the ultimate decisions, but is still maturing during adolescence and into a person’s mid-20s at least.



In the article, Steinberg says that the socioemotional network is not in a state of constantly high activation during adolescence. When the socioemotional network is not highly activated -- for example, when individuals are not emotionally excited or are alone -- the cognitive-control network is strong enough to impose regulatory control over impulsive and risky behavior, even in early adolescence.



In the presence of peers, however, or in situations where emotions run high, the socioemotional network becomes sufficiently activated to diminish the regulatory effectiveness of the cognitive-control network.


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Expert Back From Afghanistan: U.S. 'Cannot Afford To Lose 2 Wars'

The U.S. government must do more to deal with its less-publicized war -- the ongoing conflict against the Taliban and other forces in Afghanistan, according to a Washington expert who recently returned from Afghanistan.



The United States, which ousted Afghanistan's Taliban regime in 2001 following the Sept. 11 terrorist attacks, must, for instance, put the survival needs of the Afghan people ahead of drug eradication, says Anthony Cordesman of the Center for Strategic & International Studies in Washington.



If Afghanistan does not get more support from the United States, it is almost certain that the Taliban and hostile elements in Afghanistan will have a much more successful 2007 offensive than they had in 2006, Cordesman says. "And we really, to put it bluntly, cannot afford to lose two wars. And I think that is the path that we are headed on without urgent action," he says.



U.S. and NATO forces are winning tactically in Afghanistan, Cordesman says.



"The problem with that is we won tactically in Vietnam," he says. "We are winning tactically in Iraq. The problems are not tactical victory; the problems are, are you actually gaining control of the countryside? Are you actually winning political support? Are you reducing Taliban influence or are you watching it expand? Are you developing effective NATO forces or are you keeping what people in Afghanistan call stand-aside forces? Do you have enough U.S. forces? Can you take an aid mission, which now is limited by finance and manpower to what, in some ways, are projects, which, while important, are more showpiece than projects that reach into the field, and substitute for the lack of Afghan governance in the field until you can develop that Afghan governance?"

Afghanistan needs about $6 billion in aid, or roughly three times higher than what the U.S. government is spending, Cordesman says. "And depending on how you define this, this is either half of a month in Iraq, or it is a month in Iraq, depending on how you are doing the counting," he says.



Afghans living in the countryside of Afghanistan are without water, without power, who do not have roads to get to an area where they can function, where it will take time to get them basic clinics and schools, Cordesman says.



"You are talking about a society in which people have drug loans to start the year – essentially a sharecropping type system," he says. "To put eradication before survival is a disastrous aid to the Taliban. And we have to have a program which links this to an overall development program and to a counterinsurgency campaign."

Afghanistan is a producer and exporter of poppies from which heroin is made.

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Computer Sim Monitors Contraband Nuke Traffic

A Sandia National Laboratories researcher has developed a simulation program designed to track the illicit trade in fissile and nonfissile radiological material well enough to predict who is building the next nuclear weapon and where they are doing it.

“By using a cluster analysis algorithm coded into a program,” says Sandia researcher David York. “I evaluated those traffic patterns and routes in which thefts, seizures, and destinations of materials were reported. Data from these examinations were enough to allow me to retrospectively depict the A. Q. Kahn network before it was uncovered.”

Kahn is a Pakistani scientist linked to the illicit proliferation of nuclear technical knowledge. Cluster analyses link data of common place, time, or material. Testing a computer simulation on a known past event is one accepted means of establishing the program’s validity.

Sandia is a U.S. National Nuclear Security Administration laboratory.

In the Kahn analysis, York generated an analysis of networked routes indicative of a nuclear trafficking scheme between countries. In several verified incidents, inspectors seized uranium enriched to 80 percent, as well as dual-use items indicative of small-scale development of crude nuclear devices.

In the study, York collected and collated data from 800 open-source incidents from 1992 to the present, along with the movement of dual-use items like beryllium and zirconium. He plotted the incidents on a global information system (GIS) software platform. He came up with a network of countries and routes between countries indicative of an illicit nuclear and radiological trafficking scheme.

“The number of incidents and the quantity and quality of material seized is disturbing,” York says, “particularly because this may represent a small percentage of the actual amount of material being trafficked.”

The situation may be worse than it appears because much information about nuclear material traffic is classified, York says, to prevent embarrassment to countries through which a nuclear weapon or the materials to fabricate a weapon may have passed.

York presented his results in October at the International Safeguards Conference sponsored by the United Nation’s International Atomic Energy Agency (IAEA) in Vienna, Austria. He has also been invited to present his methods and conclusions to the European Union’s Illicit Trafficking Working Group at the June meeting of the IAEA.

How does the method work? “One begins by conducting cluster analyses on the GIS platform for material or activity similar to the incident in question. This gives the analyst an idea of corridors used by potential smugglers. It also indicates where the material might have come from and where it is,” says York. “If the trafficker has only a certain amount of time to reach a destination and you have that information, one can ask what is the shortest route from point A to point B, or find major highways needed to accommodate a large shipment.”

For the tool to be effective, “Enough information must be collected under a cooperative international framework,” York says. “Then info must be analyzed to separate patterns from noise, essentially creating intelligence.”

Nation-states that reuse nuclear fuel through reprocessing can create and ship dangerous materials that previously were confined to the more industrialized world.

“We’re trying to develop a market niche for this kind of tracking program,” says Sandia manager Gary Rochau, “and I think we’re ahead of everyone’s headlights.”

The method can be used to track other materials, such as drugs. “We have a lot of interest from a lot of agencies,” says Rochau.

Trafficking may be engaged in by amateur smugglers trying to feed their families in a post-Soviet era. It may also be practiced by those involved in organized crime who find a lucrative market in moving illicit materials, and by terrorists interested in the potential devastation and psychological effects of the use of nuclear materials.


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Research House To Develop Treatments for SARS, Bird Flu, More

SRI International, a nonprofit research and development organization, has been awarded a $56.9 million contract with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to provide preclinical services for the development of drugs and antibodies for anti-infective therapeutics.

SRI will provide five years of support for the development of treatments for avian flu, SARS, West Nile virus, hepatitis, and biodefense pathogens and toxins. SRI will perform medicinal chemistry, custom drug synthesis, formulation, analytical chemistry, clinical manufacturing, microbiology and virology screening, pharmacokinetics, safety testing, and preparation of Investigational New Drug (IND) applications to the U.S. Food and Drug Administration.

"We are very excited to have won this important contract, which further establishes SRI as one of the foremost anti-infective contract research organizations in the United States," says Jon Mirsalis, Ph.D., D.A.B.T., managing director of SRI’s Biosciences Division and principal investigator for the program. "This major project, coupled with SRI’s basic research groups, demonstrates SRI’s capabilities to take projects from idea to IND stage."

In addition to this contract for anti-infective therapeutic development, SRI has worked for many years with NIAID’s Division of AIDS conducting safety, formulation, and clinical manufacturing projects, as well as with the NIAID biodefense safety, vaccine, and screening programs.

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