Pew funds Center's new consumer genetics project

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Pew funds Center's new consumer genetics project

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The Pew Charitable Trust has awarded $750,000 to the Genetics and Public Policy

Center for a new project focused on consumer protections for applications of

genetic testing.

The Consumer Genetics Project takes aim at a new issue area for the Center,

incorporation of genetic testing information into drug labeling. The Project

also focuses on continuing work in two areas, truth of claims made by genetic

testing companies, and genetic discrimination.

" The Center's work on these issues to date has been aggressive and successful,

but the technology and business environments for genetic testing have changed

dramatically, creating new opportunities for protecting the consumer public and

ensuring genetic testing quality, " explains Center Director Kathy Hudson. " While

we will need to continue efforts to ensure that needed and now widely endorsed

regulatory reforms are implemented to ensure tests' accuracy and validity, new

measures are needed to protect consumers from harm and to reap the benefits of

genetic testing. "

For example, she notes, adverse reactions and failure to respond properly to

pharmaceuticals pose significant challenges for patient care. Adverse drug

reactions are responsible for more than two million hospitalizations every year

and more than 100,000 fatalities, making them the fourth leading cause of death

in the United States. An estimated $1.5-4 billion is spent each year on

hospitalizations associated with adverse drug reactions.

Drawing on the tools and technologies that emerged from the Human Genome

Project, researchers are identifying genetic variants that affect how

individuals respond to pharmaceuticals. This has led to great optimism among

numerous stakeholders -- including pharmaceutical companies, physicians, payers,

and patient advocacy groups -- that pharmacogenetic information will

substantially improve the safety and effectiveness of drugs, leading to fewer

adverse events, improved patient outcomes, and reduced health care costs.

Proponents of personalized medicine posit that, armed with pharmacogenetic data,

physicians will be able to get the " right drug to the right patient at the right

time. "

To date, however, there have been few examples of pharmacogenetic information

being translated successfully into clinical care. Moreover, our preliminary

research reveals that, even where pharmacogenetic data support a change in

clinical practice that would increase drug safety and/or effectiveness, there is

significant variability in whether that information reaches physicians in a

timely fashion and in a way that leads to a change in practice and improved

patient care. While the Food and Drug Administration (FDA) has issued guidance

documents indicating that it appreciates the significant potential value of

pharmacogenetics to foster its mission of protecting public health, the agency

has not developed a clear and consistent regulatory pathway to support the

timely and effective integration of pharmacogenetic data into drug labels.

" We are evaluating the amount of evidence required by FDA to support labeling

changes, the amount of time required to implement such changes, and the clarity

of communication about the implications of the information for clinical care, "

according to Gail Javitt, the Center's law and policy director. While FDA has a

clearly defined role in determining the efficacy and safety of drugs on the

market, she says, the agency does not have a clear role in the regulation of

genetic tests. Most genetic tests are not reviewed by FDA or any other third

party to ensure their clinical validity. " FDA's lack of involvement makes it

difficult for anyone to determine whether pharmacogenetic claims made by those

offering genetic tests are accurate, " Javitt says.

Similarly, the Center has established in previous work that consumers who order

tests directly from genetic testing companies (rather than through their health

providers) face a welter of confusing state laws regarding who may order and

receive genetic tests, and what standards are in place to monitor genetic

testing companies.

With respect to truth in advertising about genetic testing claims, the Center

discovered in earlier work that " companies are making scientifically

unsupportable claims and consumers are putting their health as well as their

pocketbooks at risk, " Javitt notes. " While the Federal Trade Commission (FTC)

has the authority to take action to protect the public against false and

misleading advertising, it has taken no action to date on advertising claims

about genetic tests. "

This initiative, based on a pilot study published by the Center in Science

magazine that compared claims made about genetic testing to the scientific

evidence, will support additional policy-relevant data collection and analyses

to inform the public, encourage companies to more closely match their

advertising to truth, and may provide evidence to support heightened attention

from the FTC.

Lastly, the CGP will continue the Center's work that led to passage in 2008 of

the Genetic Information Nondiscrimination Act (GINA). Hailed on the Senate floor

as " the first major new civil rights bill of the new century, " GINA is a

critical and welcome assurance to consumers that their genetic information will

not be used against them, according to nah Baruch, law and policy director

for the Center. " But a considerable amount of work is necessary to ensure that

GINA is appropriately implemented and enforced, and to examine genetic

discrimination issues that remain, " she says. The Center will examine policy

options for areas not covered by GINA, such as discrimination in life insurance,

long-term care insurance, and disability insurance markets; privacy of genetic

information; and surreptitious testing.

The Pew Charitable Trusts established the Center in 2002 with an initial $10

million grant to s Hopkins University. An independent nonprofit, Pew

partners with a diverse range of donors, public and private organizations, and

concerned citizens who share its commitment to fact-based solutions and

goal-driven investments to improve society. – Rick Borchelt