By Gina Kolata
May 21, 2018
Dr. Nikhil Wagle thought
he had a brilliant idea to advance research and patient care.
Dr. Wagle, an oncologist
at the Dana Farber Cancer Institute in Boston, and his colleagues would build a
huge database that linked cancer patients’ medical records, treatments and
outcomes with their genetic backgrounds and the genetics of their tumors.
The database would also
include patients’ own experiences. How ill did they feel with the treatments?
What was their quality of
life? The database would find patterns that would tell doctors what treatment
was best for each patient and what patients might expect.
The holdup, he thought,
would be finding patients. Instead, the real impediment turned out to be
gathering their medical records.
In the United States,
there is no single format used by all providers, and hospitals have no incentive
to make it easy to transfer records from one place to another. The medical
records mess is hobbling research and impeding attempts to improve patient
care.
“Data are trapped,” said
Dr. Ned Sharpless, director of the National Cancer Institute. “This is a huge
problem. It is phenomenally important.”
The cancer institute has
invested millions of dollars into determining the genetic sequences of
patients’ tumors, and researchers have found thousands of genes that seem to
drive tumor growth.
But until patients’
medical records are linked to the genetic data, life-or-death questions cannot
be answered.
“What drug did they get?
Did they respond? Did they survive? Were they cured?” Dr. Sharpless asked.
The federal government
has mandated uniform standards for electronic health records. “At this point,
they are not to a level that helps with the detailed clinical data that we need
for the scientific questions we want to ask,” Dr. Wagle said.
A few private companies
are trying to tackle the problem. Flatiron Health, just bought by Roche, has
obtained about 2.2 million records of cancer patients from medical centers and
made them available for research after stripping them of identifiable
information.
But Flatiron must employ
900 nurses and certified tumor registrars, people with master’s degrees in
coding data, to put it all into a usable form.
“About 50 percent, if not
more, of the critical details we need for research are trapped in unstructured
documents,” said Dr. Amy Abernethy, the company’s chief medical officer.
“They are in PDFs. Maybe
a doctor put in a note by hand, maybe a doctor typed it. That note became a
narrative. It is not something that can easily be put into a spreadsheet.”
Dr. Sharpless worries
that the data acquired by companies like Flatiron will not be readily available
to researchers. But if the companies manage to solve the medical records
problem cheaply, he said, “we’d like to work with them to figure out how to
liberate the data.”
Dr. Wagle is making data
from medical records and patients’ experiences public as he gets them. After 2
1/2 years, though, he is disappointed by how little there is to share.
The patient who inspired
his project had a lethal form of thyroid cancer. She was expected to die in a
few months. In desperation, doctors gave her a drug that by all accounts should
not have helped.
To everyone’s surprise,
her tumors shrank to almost nothing, and she survived. She was an
“extraordinary responder.”
Why? It turned out that
her tumor had an unusual mutation that made it vulnerable to the drug.
And that got Dr. Wagle
thinking. What if researchers had a database that would allow them to find
these lucky patients, examine their tumors, and discover genetic mutations that
predict which drugs will work?
And what about those who
were not helped by standard treatments? Could they be identified and spared
treatments that will not work?
What researchers needed
was a huge database that collected clinical and genetic data, along with
patients’ descriptions of their experiences. Those narratives are crucial, Dr.
Wagle said, but they are absent from the commercial databases like Flatiron’s.
Those comprise anonymous patient data, making it impossible to ask the patients
themselves how they fared.
Dr. Wagle decided to
build a database, starting with metastatic breast cancer, his specialty. There
are about 155,000 metastatic breast cancer patients in the United States. He
would use social media, online forums and advocacy groups to reach out to
patients for their records.
The Metastatic Breast
Cancer Project began in October 2015. Patients have been eager to join, and
advocacy groups enthusiastically signed on. So far, the project includes 4,400
women.
Determining the genetic
sequences of their tumors and of their healthy cells was straightforward — “the
easy part,” Dr. Wagle said.
Gathering their medical
records was another story. The data exist in all sorts of formats, and crucial
information may be missing altogether.
Simply getting the
records delivered, in whatever format, has been a nightmare. Records usually
arrive as faxes or via snail mail.
“Even though the patients
are saying, ‘I have consented for you to obtain my medical records,’ there is
no good way to get them,” Dr. Wagle said.
He hired half a dozen
people to work full-time on the project, and corralled doctors and other
experts to help part-time. It can take hours to go through a single medical
record.
Mary McGillicuddy, who
works full-time on the project, explained the system. When patients enroll,
they tell the investigators where they were treated, where they had biopsies,
where they had scans, and where they had medical procedures.
They give Ms.
McGillicuddy and her colleagues permission to request their records. Ms.
McGillicuddy faxes requests for records to each medical institution that
treated a patient, or diagnosed or sequenced her cancer.
Startlingly, faxing “is
the standard,” Ms. McGillicuddy said, for medical records requests.
The process can be
frustrating. Fax numbers can be out of date. Some medical centers will not
accept electronic patient signatures on the permission forms.
Sometimes, the medical
centers just ignore the request — and the second request. In the end, Ms.
McGillicuddy said, the project gets fewer than half the records it requests.
Then comes the laborious
task of extracting medical information from the records and entering it into
the database. A faxed medical record may be 100 or 200 pages long.
So far, the breast cancer
project has received 450 records for 375 patients. (Each patient tends to have
more than one record, because the women typically are seen at more than one
medical center.)
“Patients are incredibly engaged and excited,” Dr. Wagle said.
But for the records problem, “right now there isn’t a good solution.”
Correction: May
20, 2018
An earlier version of this article described
incorrectly Dr. Amy Abernethy’s role at Flatiron Health. She is its chief
medical officer, not its founder. In addition, the article misstated the number
of medical records obtained by the company. The figure is 2.2 million, not 1
million.
Follow
@NYTHealth on Twitter. | Sign up for the Science Times newsletter.
A version of this article appears in print on May 21, 2018,
on Page D4 of the New York edition with the
headline: Concealing New Cancer Treatments. Order Reprints | Today’s Paper | Subscribe
https://www.nytimes.com/2018/05/21/health/medical-records-cancer.html?utm_campaign=AIS%20Health%20Daily&utm_source=hs_email&utm_medium=email&utm_content=63197688&_hsenc=p2ANqtz-_m9JC1gwizZLcSX9Muis9fn43tPN2kfxxr136Fs82t8QMClrrlZ61u9UWHiavQJftRXRXtgDuKHx3_vkQlTx5WrxSzoQ&_hsmi=63197688
No comments:
Post a Comment