Last spring, the Food and Drug Administration approved an important test that can detect Alzheimer's early on.
The brain scan checks for amyloid, a protein that warns of the degenerative brain disorder.
“It’s expensive, but everyone at the age of 60 is going to want that test. I don’t know if the system will allow that in the current structure,” said Steve Poceta, head of the Scripps Clinic division of neurology.
Poceta and other bright minds in the fields of science and technology gathered at a recent roundtable at The Daily Transcript to discuss ways today’s health care system can keep up with advances in medicine.
Poceta is worried about the infrastructure of the medical delivery system and whether there’s going to be enough trained doctors to allow for the innovations to occur.
He said the training he received 25 years ago doesn’t take into account new technologies, such as personalized medicine. Finding a way to educate medical professionals, patients and insurance companies will be a huge challenge.
“Most doctors don’t understand the vocabulary used around the table. There are a number of commercially available tests for certain diagnoses," Poceta said. "There are so many more coming along."
What is more disturbing, says Casey Fatch, chief operating officer of Tri-City Medical Center, is that the new U.S. health care system could mimic what happened with the aerospace industry.
“We hitch a ride to space with Russians now," Fatch said. "Everyone wants the latest and greatest technology, but no one wants to fund it. Until we figure out how this is going to work, there might be a real slowdown in technology.”
The FDA is attempting to save the system money by reducing the cost of bringing drugs to market. There were 39 drug approvals in 2012, which is up from years past.
“It’s trending in the right direction from that perspective, but it’s still a balance between safety and efficacy,” said Timothy Scott, president of Pharmatek. “You may have a drug that is efficacious but may not be safe.”
A new drug designation, called a “breakthrough therapy,” gives the drug a faster track to approval. Similar to cancer drugs or orphan-designated drugs, it also grants a cheaper clinical path to approval.
One improvement that could be made within the drug approval system is by bringing a third-party patient advocacy group to the table, which is filled by pharma on one side and the FDA on the other. That would change the dynamics of how the groups are connected and move responsibility among three parties, instead of two.
“If the patient is willing to take those risks and take that new drug because they don’t have an alternative, it takes part of the liability off of the FDA and drug company,” Scott said.
While the drug approvals process is still caught up in some kinks, genomic testing has come a long way in just a few years. Five years ago, Scott’s entire family spit in a cup so that 23andMe could study their traits.
“At that time, it was interesting more than anything else,” he said. “You could compare and see which of the children had DNA closest to you and grandparents.”
Fast forward to today, MD Revolution is now using genetic testing to dole out nutrition advice, such as staying away from different foods the person could be allergic to.
“This is moving quickly, getting cheaper and the FDA is saying, let’s get this information digitized so life is easier and Medicare is cheaper,” he said. “There’s a convergence of technology coming together that will change the way medicine is provided in the future.”
Mining sequenced data has a number of applications, such as cancer detection, noted Alex Dickinson, senior vice president of cloud genomics at Illumina Inc. (Nasdaq: ILMN)
Illumina is sequencing 1,000 terabytes of information a week. Today, people can get their entire genome sequenced for $1,000, but the industry needs to find a way to regulate how it processes data.
“How to bring information to different stakeholders from a common place. It becomes a valuable tool to advance patient care. There’s excitement in front of us, but also challenges,” said Greg Frost, president and CEO of Halozyme Therapeutics Inc. (Nasdaq: HALO)
Frost questioned how electronic medical records will work within the system.
“Will there be a big enough Internet pipeline into the hospital for managing all this?” Frost asked.
While there is some hesitation to put patient records in the cloud, mainly due to privacy concerns, Poceta thinks the industry will get over that stigma.
“Privacy is a concern but I think that can be handled technologically,” he said.
Scott points out that in 1999, when the Internet was getting started, people slowly gave in to the idea of sharing their personal information online. At some point, when babies are born, all their records are going to be electronic and tied to their Social Security numbers throughout their lives, he added.
For now, there are some compliance issues that stand in the way. This month, the Department of Health and Human Services released a revision to HIPPA rules, said Kevin Derrick, president of EA Health.
“They are making it harder, and rightfully, so for an organization to truly share data, so it’s really a struggle,” Derrick said.
There are still some structural issues on the administrative side that have to be dealt with.
“You need to encrypt everything and be aware of any time someone views or touches data, and why and what path was used to grant them permission to do that," Derrick said.
Patent wars are also a hot spot of discussion in the ever-changing technological world. There needs to be changes to patent laws and industries need to find creative ways to work together, Frost said.
“There’s a great deal of litigation happening in that area,” Dickinson added. “There are already the issues of patents. It’s going to be a long road I suspect.”
As technology develops quickly, Fatch said there needs to be a conversation around how it’s going to be implemented in the clinical setting.
“We do a poor job, in some cases, with technology we don’t understand," he said. “This industry doesn’t do a great job of rolling out technology sometimes. I think there will be a stumbling block.”
Leticia Cano, President, Biomarker Profiles Corporation
Jack DeFranco, President & CEO, Targeson
Kevin Derrick, President, EA Health
Alex Dickinson, Senior Vice President, Cloud Genomics at Illumina Inc.
Casey Fatch, COO, Tri-City Medical Center
Greg Frost, President & CEO, Halozyme Therapeutics Inc.
Steve Poceta, Division of Neurology Head, Scripps Clinic
Timothy Scott, President, Pharmatek