Sin Hang Lee, MD, uses DNA sequencing for early diagnosis of Lyme Disease at Milford Molecular Diagnostics, LLC at 2044 Bridgeport Avenue in Milford, Conn. on Tuesday, November 13, 2018. Lee is suing the CDC over their current method of testing for the disease.
MILFORD — A scientist in Milford who has devised a way to use DNA matching technology to determine if a patient has Lyme Disease has accused the Centers for Disease Control and Prevention of suppressing his test and depriving him of $57.1 million in profits.
Dr. Sin Hang Lee filed suit in federal court in October, saying the CDC, a federal agency, has engaged in an “anti-competitive campaign to stifle” his test and has impugned his reputation and that of his research.
Although the federal government is protected under its sovereign immunity clause, there are cases that are allowed to move forward, such as those involving breach of contract. Lee’s attorney, Mary Alice Moore Leonhardt, contends this is one of those instances.
The CDC’s lawyers have filed for dismissal of the case, but so far it’s on track to be heard, Leonhardt said, in the U.S. Court of Federal Claims in Washington, D.C.
“The $57 million figure is based on the value of his intellectual property for this test that he developed over 20 years,” she said, “as well as the impact of the lost use of this technology — technology that he shared with the CDC.”
Attempts to contact Dr. Beth P. Bell, the former CDC director named as a co-defendant in the lawsuit, were not successful. And a spokesperson for the agency did not respond to requsts for comment this week.
Contrasting methods
Twenty years ago, Lee began working on a test for Lyme disease based on DNA sampling and he said his creation was nearly fool-proof. In 2013, he offered it to the CDC.
“The serology test that the CDC prefers — it’s also known as the Western Blot Test — is famous for its false positives,” Lee said. “You may have had Lyme disease 10 years ago that didn’t produce symptoms, but with the CDC test, you’d test positive even though you don’t have it now.”
Lee says that the Western blot test also produces false negatives.
“The science is very straightforward,” Lee said. “No one can refute DNA sequencing — not even the CDC. Even back in 2012, the CDC realized that the serology test had problems.”
Lee’s suit said the CDC had, as early as 2010, held a workshop on tick-borne illnesses in an effort to develop more accurate diagnostic tools and tests for Lyme disease. In 2012, the agency reiterated its need for a better test through what the suit describes as “soliciting submissions and offering business opportunities to members of the public in order to solve a national health problem.”
“The world’s scientific literature agrees that DNA sequencing of bacterial genes in patient specimens is a tool to reach irrefutable diagnosis of bacterial infections, including those due to borrelia, even if antibodies to the bacteria in the patient are not measurable,” Lee said.
‘A nasty pit’
Lee is being backed up by the Lyme Action Network, which provides information and builds awareness about Lyme and other tick-borne diseases
“We don’t support anything of this nature that’s not peer-reviewed, and Dr. Lee is entirely on the right track,” LAN President Chris Fisk said in a telephone interview. “The politics at the CDC with regard to Lyme disease is a nasty pit — no other way to describe it.”
According to the suit, in 2013, the CDC agreed to provide samples to Lee to test his protocols with “the ultimate goal of the contract (being) to establish the ... test ...that was sought after by the CDC.”
Despite working with CDC physicians through most of 2013 and receiving positive feedback, in January 2014, Lee’s suit says, the representatives of the agency stopped communicating with him. He sent several emails asking for the status of his project and published the findings of the tests in a scientific journal giving credit to CDC’s support.
The suit states the CDC “publicly stated that in the March 2014 article, Lee and (another researcher) reported inconsistent results” and would not answer Lee when he asked what inconsistent results the agency meant. Instead, according to the suit, the CDC referred Lee to its attorney.
Since then, the suit states, the CDC has refused to answer Lee’s questions or withdraw its statement on “inconsistent results.”
In response, Lee filed a formal complaint of the CDC and in October, filed the federal suit.
Leonhardt said that if Lee prevails in court and is awarded a settlement, “that money will be used to create Lyme disease testing laboratories throughout the U.S., so people can be accurately tested.”
The suit charges the CDC “of employing false, pseudo-scientific theories in order to justify its own anti-consumer actions aimed at perpetuating Lyme disease testing by a flawed technology.”
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