Posted on December 8, 2016
U.S. Sen. Lamar Alexander, R-Tenn., is touting the 21st Century Cures bill, which the Senate and House have now passed and President Barack Obama is expected to sign, as "the most important bill of the year."
The sprawling 996-page legislation is the most significant health care law passed by Congress since Obamacare, and it won bipartisan backing, passing the U.S. House last week by a vote of 344-77 and winning Senate approval on Wednesday, 94-5. As chairman of the Senate Health, Education, Labor and Pensions Committee, Tennessee's senior U.S. senator has been a key architect of the bill.
The $6.3 billion legislation includes $1 billion to fight opioid abuse and $1.8 billion for Vice President Joe Biden's "cancer moonshot" initiative; changes the way the federal Food and Drug Administration approves drugs and medical devices; and pushes hospitals and doctors to make it easy to share data on their patients electronically.
Sen. Bob Corker, R-Tenn., praised the Senate's vote Wednesday and applauded Alexander.
"Passage of this legislation is a testament to Sen. Alexander's leadership and will help countless Tennesseans who are directly impacted by cancer, Alzheimer's, mental illness and opioid abuse," Corker said. "By streamlining the FDA review process and advancing biomedical research, this bill will encourage innovation and provide quicker access to the lifesaving medications and treatments that so many families need."
In an interview with the Times-Free Press, Alexander touted the money to fight opioid abuse as particularly important for the state.
"In almost every Tennessee county, doctors and parents are heartbroken by the amount of opioid drug abuse and by its consequences," he said.
The funding can help provide treatment for opioid abusers and train doctors and other health care professionals in the best way to treat addiction, said Dr. David Stern, dean of the University of Tennessee College of Medicine.
UT recently established a Center for Addiction Science to research ways some people may be predisposed toward addiction. As an example, he cited neonatal abstinence syndrome, something some infants suffer when they are born to mothers who are drug addicts. The infant is also born with the addiction and suffers withdrawal symptoms that can have severe consequences for their healthy development, Stern said. But the severity of the withdrawal symptoms varies widely, and Stern said research is needed to figure out why that occurs. Knowing in advance which infants are most likely to have major problems would allow doctors to focus on their care, lessening the impact on their long-term health and also helping control the state budget.
"Babies stay in [neonatal intensive care] for a long time and that has a big impact on the TennCare budget — and it is particularly bad in East Tennessee," Stern said.
He hopes the new funding will allow him to enlarge a program to train a workforce of doctors and other health care workers who specialize in addiction.
"We would like to train a workforce that knows how to do state-of-the-art treatment," he said, "and change the culture from saying a person with a substance abuse addiction has a weak moral character and is a person not to associate with, to realizing that, no, this is a medical problem."
CANCER RESEARCH AND PRECISION MEDICINE
One of the most promising discoveries researchers have made recently is the role a person's DNA plays in determining whether they are vulnerable to cancer or other diseases and what treatment may be effective for their particular variation of the disease.
Among other things, the "cancer moonshot" is an effort to pull together data doctors obtain from individual patients into huge databases where researchers can determine which genes are linked to what particular forms of cancer and other diseases, making it easier to develop drugs or other treatment plans to target them.
"Your doctor will prescribe medicine based on your individual genome," Alexander said. "For the same disease, you may not get the same medicine because your genetic makeup may be different. We are on the brink of exciting breakthroughs in finding new ways to treat cancer. And within the next 10 years, we will have medicines that will help us identify Alzheimer's before the symptoms are evident, and that will save enormous amounts of grief for families and save our country billions and billions of dollars."
Stern noted that understanding a patient's genetic makeup would help with both diagnosis and treatment. To find the best treatment, for example, doctors would like to know: "How does my body metabolize or use certain drugs — what would be effective in you, ineffective in me, and toxic in someone else?"
And doctors are increasingly realizing that DNA affects how vulnerable you are to a disease.
"Your genes make someone susceptible to breast cancer or colorectal cancer," Stern said.
He hopes increased funding will allow UT researchers to study the makeup of two groups of Tennesseans in particular — blacks and people who live in Appalachia.
"One weakness in our current data is the lack of inclusion of significant numbers of minorities, both African- American and Appalachian," he said. "Having that kind of diversity is important to tell us which polymorphisms [variations] of the gene are relevant and which are not."
APPROVING DRUGS AND MEDICAL DEVICES
The most controversial part of the legislation has been the way it changes how the U.S. Food and Drug Administration approves new drugs and medical devices.
Supporters say the current tests the FDA requires take too long and are too expensive.
"Right now, if a drug company is developing a medicine for Alzheimer's or cystic fibrosis, it takes 15 years and $2 billion before they produce the first drug because of regulatory barriers," Alexander said. "It costs too much. We're trying to reduce the cost and reduce the amount of time it takes and still make it safe."
Critics, including Sens. Elizabeth Warren, D-Mass., and Bernie Sanders, I-Vt., argued that under the new rules, drug companies could make claims for drugs without proving they are effective.
They say lower testing requirements could result in the approval of drugs with dangerous side effects.
"People can sell these treatments without meeting the FDA gold standards for protecting patient safety and making sure these drugs do some good," Warren said in a speech on the Senate floor.
Balancing the need to get possibly life-saving drugs into doctors' hands quickly versus ensuring dangerous drugs stay off the market is difficult, Stern said. The amount of risk a patient is willing to take with a new drug often depends on their circumstances.
"If I'm someone with another month left on cancer, I may be willing to accept the toxicity," he said.
MAKE MEDICAL RECORDS SHAREABLE
The part of the legislation that almost everyone may see soon involves electronic health records — also known as electronic medical records, or EMR.
Currently, most hospitals are spending large sums converting all of their paper records into a comprehensive computer system covering most areas of the hospital. Erlanger has 100 staffers working on its EPIC system, which will cost $100 million over 10 years, while CHI Memorial is making a decision on what system it will purchase.
But the records are unpopular with doctors, who argue the systems require them to spend more time entering data into a computer and less time interacting with patients. And they also are criticized for storing data in a format that is not shareable with other hospitals or doctors.
"Right now, if you want to take your medical records from Erlanger to the Mayo Clinic, your best bet is to go down there and put them in a briefcase and take them to Rochester, Minn. [where the Mayo Clinic is located]," Alexander said. "We would like for doctors and hospitals in different locations to be able to go in and find out what your ailments are, what your medicines are, what your medical history is — to make all the machines and data talk to each other and be easy to use.
"We'd like it to be as simple as buying an airline ticket — where you take it for granted you can go on your computer and make a reservation," he said.
"The electronic medical record is something that all doctors detest," UT's Stern said. "The reason they detest it is it is cumbersome, and instead of the doctor looking into your face, they often are typing and looking down. It is almost a barrier to interaction rather than something that facilitates interaction."
On the other hand, he said, gathering that data is critical to improving patient care.
"The EMR is a very important tool — how can you tell what we did and if what we did led to better outcomes?" Stern said. "We have to have that."
Having a person's complete medical record available anywhere could also be a lifesaver.
"As patients, you and I want it to be that wherever we go, someone can figure out information about us in case we are unconscious, so someone would know what medicines you took, what disorders you had," he said.
"It is an imperfect tool, and it will require the government to mandate that it get better and better and be more friendly to patients and doctors," Stern said.