DC Dispatch Clinical Trial Reform

Four Democrats, led by Congressman Edward J. Markey of Massachusetts, introduced a bill to the House of Representatives that aims to close some of the loopholes in clinical trial reporting. If passed, the Trial and Experimental Studies Transparency (TEST) Act of 2012 would help to better maintain the clinical trial registry data bank ClinicalTrials.gov using stronger reporting requirements. For instance, all foreign clinical studies being conducted to support an application for U.S. marketing would have to comply with the regulations of the database. According to the bill’s backers, 80% of the drugs that entered the market in 2008 were tested overseas, and many of those trials did not have to be registered in the database.

Markey, along with co-sponsors Reps. Henry A. Waxman (CA), Rosa DeLauro (CT), and Jan Schakowsky (IL), says that this bill would improve patient safety because data obtained from previous trials could contain information that would prevent unnecessary risks to participants during future trials for similar drugs. The TEST Act would also require all trials involving human testing to be registered with the database before the first participant is enrolled, require results to be posted within one year of the completion of the trial (expect for trials for never-before-approved treatments which will have two years), and instruct NIH and the FDA to provide a report to Congress regarding compliance with the requirements.

The odds of the bill passing are unknown at this time, but it could pose a threat to industry-sponsored trials if companies prefer to keep proprietary information from reaching competitors.

Discoveries/Innovations

Is a cure for HIV on the way? The 19th International AIDS Conference held in July offered some renewed hope for HIV patients that a cure may be on the horizon. A new study revealed that two people may soon join Timothy Ray Brown (aka the “Berlin Patient”) as the only person to be “cured” of the disease. Brown conquered HIV while being treated for leukemia via bone marrow transplants that used donor cells resistant to HIV infection because they lacked a key HIV receptor. While bone marrow transplants cannot routinely be used for this purpose, there are several studies investigating the procedure, according to ABC News.

Researchers from the University of North Carolina at Chapel Hill (working in collaboration with scientists from the Harvard School of Public Health, National Cancer Institute, Merck, and the University of California at San Diego) also used bone marrow transplants in HIV patients receiving treatment for cancer (this time lymphoma). However, this time the donor cells did not lack the resistant receptor while the patients also got a milder form of pre-transplant chemotherapy so that they could remain on their antiretroviral HIV medication. The researchers believe that the continuous administration of the antiretroviral therapy protected the new cells from becoming HIV infected as they replaced the patients’ immune cells, which may have left them HIV free.

“We can’t find evidence of HIV infection in the patients’ blood or blood plasma, and their antibody levels against HIV are dropping,” Dr. Daniel Kuritzkes of Brigham and Women’s Hospital told Shots, NPR’s Health Blog. “We can’t say we’ve replicated the Berlin patient’s cure at this point because our patients remain on antiretroviral therapy.”

Med Device
Digital Pill “Treats” Adherence

The cure for adherence, at least when caused by forgetfulness, may have arrived in the shape of a tiny microchip. The FDA has approved Proteus Digital Health’s ingestible sensor, which is just one part of Proteus’ integrated health feedback system designed to improve patients’ health habits and the ability of caregivers to monitor them. The sensor can be embedded into a pill or other ingestible products and is activated once it comes in contact with stomach fluid. A signal is then sent through the user’s body tissue to a patch worn on the skin to capture the exact time that it has been ingested. That info can then be sent to a smartphone along with other metrics including heart rate, body position and activity. Patients can also choose to have the info sent to their clinician’s or caregiver’s phone, so family members can remind patients if they forget to take their medication and doctors can keep detailed records of their patient’s medication habits.

“The FDA validation represents a major milestone in digital medicine,” says Dr. Eric Topol, professor of genomics at The Scripps Research Institute. “Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication, adherence and significantly aid chronic disease management.”

For now, however, the device is just approved for use with placebo pills in order to test its safety and efficacy. Proteus hopes to eventually implement the sensor directly into common medications. the researchers believe that the continuous administration of the antiretroviral therapy protected the new cells from becoming HIV infected as they replaced the patients’ immune cells, which may have left them HIV free.

Telemed Texts
Emrs Miss On Mental Health

The adoption of electronic medical records (EMRs) is supposed to help increase the coordination of care while helping to improve accuracy in both diagnosis and treatment, but it seems EMRs may cause more harm than good when it comes to mental health. Researchers at the University of Florida found that patients with three or more chronic medical conditions are 50% less likely to receive depression treatment in primary care practices that use EMRs compared to practices that still use paper-based records, according to the findings published in the Journal of General Internal Medicine.“While we don’t know why EMRs are associated with lower odds of depression treatment in patients with multiple conditions, we think that either they reduce the amount of interaction between patients and physicians or they focus a physician’s attention on physical health issues, pushing mental health issues off the radar screen,” lead investigator Jeffrey Harman, Ph.D., an associate professor and the Louis C. and Jane Gapenski Term Professor of Health Services Administration at the UF College of Public Health and Health Professions, told the Sun Sentinel.

Trend Setting
Bric And Generics See Revenue Growth

There’s gold in them there emerging markets. According to a new report from GlobalData, the emerging markets, including the BRIC nations (Brazil, Russia, India and China), were much more fruitful in terms of revenue growth for the top 25 pharma companies than the United States. In 2011, those American companies only saw an increase in revenue growth of 2.6% domestically, while the average growth rate for companies in the emerging regions was 7.8%. Even better, the growth rate of the top 25 companies in those regions was almost double that at 13.4%. The other area that experienced a boom in 2011 was the generics market. The top five generic companies raked in $31 billion—an 11.3% increase over the previous year. Teva Pharmaceutical Industries generated the most revenue among generic makers by bringing in $10.1 billion. Their strategy was also to look outside the U.S. as they acquired drug makers in Peru and Japan to offset the sagging domestic sales.

 

FDA Update

A Couple of Generic Firsts The FDA approved the first generic version of Actos (pioglitazone hydrochloride) tablets, which can be used along with diet and exercise to improve blood glucose control in adults with type 2 diabetes. The generic tablets will be produced by Mylan Pharmaceuticals.

Meanwhile, the agency also gave the thumbs up for the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. Apotex, Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland, Mylan, Roxane Laboratories, Sandoz, Teva Pharmaceuticals, and Torrent Pharmaceuticals will manufacture the montelukast tablets.

2012-2013 Flu Vaccines

The strains selected for inclusion in the 2012-2013 flu vaccines are: A/California/7/2009 (H1N1)-like virus, A/Victoria/361/2011 (H3N2)-like virus, and the B/Wisconsin/1/2010-like virus. The approved vaccines include: CSL Limited’s Afluria; GlaxoSmithKline Biologicals’ Fluarix; ID Biomedical Corporation’s FluLaval; MedImmune Vaccines’ FluMist; Novartis Vaccines and Diagnostics Limited’s Fluvirin; and Sanofi Pasteur’s Fluzone, Fluzone High-Dose and Fluzone Intradermal.

New Cancer Treatments

Sanofi-aventis’ Zaltrap (ziv-aflibercept) was approved for use in combination with a Folfiri (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer. Zaltrap is intended for patients whose cancer has spread to other parts of the body and whose tumors are resistant to or have progressed after an oxaliplatin-containing chemotherapy regime.

The FDA also approved Talon Therapeutics’ Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia. It is approved for patients whose leukemia has returned two or more times, or whose leukemia has progressed following two or more regimens of anti-leukemia therapy.

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