At press time, doxorubicin remains among the several cancer medicines in short supply, FDA reports. Also recently listed were paclitaxel, cisplatin (Platinol) and pegylated liposomal doxorubicin (Doxil), sometimes used in metastatic breast cancer. (See the list at fda.gov/Drugs/Drug Safety/DrugShortages.) Shortages have not just affected chemotherapy. Antibiotics, anesthetics, vaccines, pain medicines and nutritional supplements fill the agency’s 100-plus-item list. Although federal law allows FDA to address shortages, until recently it did not require manufacturers to report them. Some did so voluntarily, but the system left doctors uncertain about supply. “When we decide a treatment regimen, we now add to the list [of issues to consider] how available is this drug going to be in the next three or six months,” says Rick Frame, MD, a medical oncologist at Utah Cancer Specialists in Salt Lake City. “We find ourselves living in this environment of, what next? When? And the ‘why’ is even more complicated.”

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News Release

HHS announces proposal to improve rules protecting human research subjects

Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight

The U.S. Department of Health and Human Services announced today that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.

“The adoption of the Common Rule two decades ago was a landmark event to ensure ethical practices and the safety of those individuals who participate in research,” said Howard K. Koh, MD, MPH, HHS assistant secretary for Health. “This regulatory review effort is primarily about enhancing protections for human subjects. The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”

The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects.

Revisions to the current regulations are now being considered because HHS believes these changes will strengthen protections for research subjects in a number of important ways.

Comment is sought on the following:

1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
3. Updating the forms and processes used for informed consent.
4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
6. Extending federal regulatory protections to apply to all research conducted atU.S.institutions receiving funding from the Common Rule agencies.
7. Providing uniform guidance on federal regulations.

The public’s input on these matters will be critically important to the government’s efforts to ensure that regulations keep up with today’s changing research environment, and will be considered by HHS as it develops new proposed rules, which will also be made public for comment.

To view the ANPRM, please visit http://www.regulations.gov, enter ID number: HHS-OPHS-2011-005 in the “Enter Keyword or ID” field, and click on “Search.”

To submit a comment, visit http://www.regulations.gov, enter the above ID number, and click on “Submit a Comment.”

For additional information about the changes under consideration, visit
http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.

The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.

In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.

“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.”

According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.

The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.

Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.

The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:

- Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.
- Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
- There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
- Women should monitor their breast implants and contact their doctor if they notice any changes.
- Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.

The FDA published its literature review in a document posted on FDA’s website site today titled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.”

The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.

Cancer researchers have discovered an important protein, produced naturally inside cells, that appears to suppress the growth of prostate cancer cells in the laboratory. The findings, published tomorrow in the journal Cancer Research, offer promising leads for research towards new treatments.

Prostate cancer is the most common cancer among men in the UK, with 37,500 men diagnosed with the disease every year. Many prostate cancers are slow growing, but in some cases the cancer is aggressive and spreads to other parts of the body, such as the bone. These cases are much more likely to be fatal.

In the new study, scientists at Imperial College London found that a protein called FUS inhibits the growth of prostate cancer cells in the laboratory, and activates pathways that lead to cell suicide.

The researchers also looked for the FUS protein in samples from prostate cancer patients. They found that in patients with high levels of FUS, the cancer was less aggressive and was less likely to spread to the bone. Higher levels of FUS also correlated with longer survival. The results suggest that FUS might be a useful marker that can give doctors an indication of how aggressive a tumour will be.

“At the moment, there’s no way to say whether a prostate tumour will kill you or be fairly harmless,” said Dr Charlotte Bevan, senior author of the study, from the Department of Surgery and Cancer at Imperial College London. “Current hormonal therapies only work for a limited time, and chemotherapy is often ineffective against prostate cancer, so there’s a real need for new treatments.

“These findings suggest that FUS might be able to suppress tumour growth and stop it from spreading to other parts of the body where it can be deadly. It’s early stages yet but if further studies confirm these findings, then FUS might be a promising target for future therapies.”

Prostate cancer depends on male hormones to progress as these hormones stimulate the cancer cells to divide, enabling the tumour to grow. Treatments that reduce hormone levels or stop them from working are initially effective, but eventually the tumour stops responding to this treatment and becomes more aggressive.

Dr Bevan and her team began by exposing prostate cancer cells to male hormones and looking at how the levels of different proteins changed. They discovered that the hormones made the cells produce less of the FUS protein, and examined further whether FUS might influence cell growth by inserting extra copies of the gene for FUS into cells grown in culture. They found that making the cells produce more FUS led to a reduction in the number of cancer cells in the dish.

Greg Brooke, first author of the study, from the Department of Surgery and Cancer at Imperial College London said: “Our study suggests that FUS is a crucial link that connects male hormones with cell division. The next step is to investigate whether FUS could be a useful test of how aggressive prostate cancer is. Then we might look for ways to boost FUS levels in patients to see if that would slow tumour growth or improve response to hormone therapy.

“If FUS really is a tumour suppressor, it might also be involved in other cancers, such as breast cancer, which has significant similarities with prostate cancer.”

The study was funded by Prostate Action, the Medical Research Council, the Imperial College Experimental Cancer Medicine Centre (set up with a grant from Cancer Research UK and the Department of Health) and the Prostate Cancer Charity.

Sources: Imperial College London, AlphaGalileo Foundation.

January: National Cervical Cancer Screening Month

March: National Colorectal Cancer Awareness month

April: National Minority Cancer Awareness Week, World Health Day, National Cancer Control Month

May: Skin cancer detection and Prevention month, Cancer research month

June: National Cancer Survivors Day

July: UV Safety month

August, September: National Prostate Cancer Awareness month, National Ovarian Cancer Awareness month, Gynecologic Cancer Awareness month, Leukemia and Lymphoma Awareness Month

October: National Breast Cancer Awareness month, National Mammography Day

November: Lung Cancer Awareness Month, Pancreatic Cancer Awareness month, National Family Caregiver month