Obama to Request Research Funding for Treatments Tailored to Patients’ DNA

President Obama is seeking hundreds of millions of dollars to develop medical treatments tailored to the individual. Dr Snyderman offers his insight in the following NYTimes article regarding this precision medicine initiative.

President Obama will seek hundreds of millions of dollars for a new initiative to develop medical treatments tailored to genetic and other characteristics of individual patients, administration officials say.

The proposal, mentioned briefly in his State of the Union address, will be described in greater detail in his budget in the coming weeks. The effort is likely to receive support from members of both parties, lawmakers said.

“This is an incredible area of promise,” said Senator Bill Cassidy, Republican of Louisiana and a gastroenterologist. “There will be bipartisan support.”

Mr. Obama called it precision medicine, but the terms “personalized medicine” and “individualized medicine” are also widely used to describe the evolving field in which, for example, a doctor prescribes a medication that targets a specific mutation in a patient’s genes.

The money would support biomedical research at the National Institutes of Healthand the regulation of diagnostic tests by the Food and Drug Administration, officials at the two agencies said.

The tests analyze the DNA in normal or diseased tissue. Doctors use that information to identify patients with cancer or other diseases who are most likely to benefit from a particular treatment — and those who would be harmed or not respond at all.

“In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable,” Mr. Obama said in his address to Congress last week.

The gene responsible for cystic fibrosis was discovered by a team that included Dr. Francis S. Collins, who is now director of the National Institutes of Health and an architect of the new initiative. The F.D.A. has approved a drug for patients with a genetic mutation responsible for some cases of the disease, which clogs the lungs with thick, sticky mucus.

A patient taking that drug, William Elder Jr., a 27-year-old medical student in Ohio, was a guest of Michelle Obama at the State of the Union speech.

Representative Fred Upton, Republican of Michigan and chairman of the Energy and Commerce Committee, and Representative Diana DeGette, a Colorado Democrat who is on the committee, welcomed Mr. Obama’s proposal. After holding hearings and round-table discussions last year, they said they were drafting a bill to encourage biomedical innovations, including personalized medicine.

As a senator in 2006 and 2007, Mr. Obama offered a bill to do just that — the Genomics and Personalized Medicine Act. Senator Richard M. Burr, Republican of North Carolina, was a co-sponsor of the 2007 bill.

“Personalized medicine represents a revolutionary and exciting change in the fundamental approach and practice of medicine,” Mr. Obama said then. He cited the drug Herceptin, for the treatment of a particularly aggressive form of breast cancer, as an example.

Scientists said they now viewed breast cancer not as a single disease, but rather as a group of several subtypes, each with a distinct molecular signature. This, they said, helps explain why some tumors respond better than others to specific cancer-fighting drugs.

“Most medical treatments have been designed for the average patient,” said Jo Handelsman, associate director of the White House Office of Science and Technology Policy. “In too many cases, this one-size-fits-all approach is not effective.”

Dr. Ralph Snyderman, a former chancellor for health affairs at Duke University, often described as the father of personalized medicine, said he was excited by the president’s initiative.

“Personalized medicine has the potential to transform our health care system, which consumes almost $3 trillion a year, 80 percent of it for preventable diseases,” Dr. Snyderman said.

Although the new tests and treatments are often expensive, he added, personalized medicine can save money while producing better results. “It focuses therapy on individuals in whom it will work,” he said. “You can avoid wasting money on people who won’t respond or will have an adverse reaction.”

The new techniques can also help prevent disease by predicting patients’ susceptibility, Dr. Snyderman said. “If an individual has a much greater likelihood of developing colon cancer, a genetically based disease,” he said, “you can begin screening at a much younger age, 30 rather than 50, for example.”

Dr. Margaret A. Hamburg, the F.D.A. commissioner, has reorganized her agency to speed the review of drugs and diagnostic tests used in personalized medicine. But Senator Cassidy said he was still skeptical. To fulfill the promise of personalized medicine, he said, will require “a much more nimble federal bureaucracy.”

On Friday, federal officials released a proposal under which Medicare would cover genetic tests of tumors in some people with advanced lung cancer. The tests could help identify Medicare beneficiaries who would respond favorably to particular cancer drugs.

“This is a watershed event,” said Dr. Bruce Quinn, a health-policy specialist at the law firm Foley Hoag. “It means that policy makers now believe these tests are worth paying for.”

Mr. Obama’s budget will also propose increased federal spending to combat antibiotic-resistant bacteria. The plan would nearly double spending from its current level of $450 million a year.

White House officials described antibiotic resistance as a threat to public health and national security. They said at least 23,000 people in the United States die each year as a result of infections caused by such drug-resistant germs.

Tagged with: , ,