QI Program Supplemental Funding Act of 2008
QI PROGRAM SUPPLEMENTAL FUNDING ACT OF 2008 -- (House of Representatives - September 27, 2008)
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Mr. SMITH of New Jersey. I thank my friend for yielding.
Mr. Speaker, first of all, I want to thank Mr. Wolf for raising this. I didn't know he was going to be doing it; I just saw him on the television.
Mr. WOLF. I didn't know I was going to be doing it until I saw the gentleman, Mr. Pallone, standing up and taking this up on suspension.
Mr. SMITH of New Jersey. So I appreciate the gentleman yielding.
Let me just say, to clarify the record, this legislation, which would seek to lay bare the science about Lyme disease, the fact that I believe we do have an epidemic, the fact that Lyme often go misdiagnosed, underdiagnosed. It is called ``the great pretender'' because so many people have it and don't know it. It often masquerades as other kinds of anomalies manifesting in a person's body. And it is not until it gets to a chronic state--very often causing severe disability, including neurological damage--that people finally realize that they have Lyme disease.
There has been, unfortunately, a significant, I believe, cover up of the fact that chronic Lyme exists. The gentleman knows, we have asked him repeatedly, the gentleman from New Jersey, my good friend, Mr. Pallone, this legislation has been pending in his subcommittee. He told Pat Smith--no relation to me--who runs a Lyme disease association, that this would get a hearing and would be marked up. It has not been marked up. And meanwhile, this epidemic is growing--it is exploding.
Now, let me just say for the enlightenment of my colleagues; the Infectious Disease Society of America, which creates--and often does a very laudable job--the definitions, the parameters of what constitutes a certain disease, has looked at Lyme and said that chronic Lyme does not exist. Many of us have raised serious concerns about that because of what we believe to be conflicts of interest on the part of the panel members that made up the Lyme panel.
I would note parenthetically that Chris Dodd is the prime sponsor of the comparison legislation that I've introduced on the House side. We have worked cooperatively on the legislation, so we have a companion bill on the Senate side. The legislation has over 110--I think it's 112--cosponsors, totally bipartisan, Democrats and Republicans alike rallying around this legislation.
The problem with the Infectious Disease Society of America is that these conflicts of interest, we believe, resulted in the conclusion that chronic Lyme doesn't exist. We don't know absolutely if that's the truth, but Attorney General Richard Blumenthal from Connecticut finally took a look at this and came back with a scathing insightful report that there were conflicts of interest. The red flag should go up everywhere.
What does my legislation do? As Mr. Pallone knows, the legislation does not prescribe a protocol, as he has suggested. It simply calls for an advisory committee that would take a good, long look at Lyme disease and determine what is fact and fiction, and finally, for the sake of all of those who are suffering immensely from this disease and their families, say what we need to be doing to mitigate and hopefully stop the spread of Lyme, whether it be long-term and very heavy antibiotic treatment--which I believe probably is the case based on clinical practitioners who have suggested that to be the case--but we want an honest look.
As Mr. Pallone knows, we did not get an honest look from the Infectious Disease Society of America. And I find that appalling. Conflict of interest with insurance companies has no place in modern medicine. And regrettably, and it has been--again, the full weight of the Attorney General's report clearly suggests, Richard Blumenthal of Connecticut, that there were significant conflicts of interest on the part of the panel members.
Our legislation says let's go where the science takes us. If the science says chronic Lyme exists, then all those patients and the insurance companies which need to be providing the coverage, to get the medicines and the like, like antibiotics--because what has happened, as my friend knows, because of this exclusion of chronic Lyme due to a problem in definition, the insurance companies say we don't have to pay. So when a patient presents with a bill of $100,000 or some excessive amount of money, the insurance companies say, not us, tough luck, we're not going to pay for it. And they go right back to what I believe to be a false definition that precludes chronic Lyme as a condition.
Now, you might think that chronic Lyme doesn't exist, I say to my friend, the chairman, but let's go where the science takes us. We need this advisory committee and we need it now. All points of view, as our legislation clearly suggests, has to be a part of this group. We want a robust debate, not something that is engineered by insurance companies.
Finally, the legislation would authorize $100 million over 5 years, $20 million each year. Frankly, if that drops off due to opposition to new authorization, and is only an authorization, I would like to see it go forward nevertheless, know this however, we're not spending enough on Lyme.
And Lyme is, as Mr. Wolf said so aptly, growing exponentially. CDC admits we are missing most of the cases. As many as 90 percent of the cases go unreported. Our state, Mr. Pallone, as you know, is number three in prevalence according to CDC numbers, and even that is probably very much understated in terms of the actual prevalence of Lyme disease.
So I would make the appeal again, as I have made to my friend from New Jersey, as I have made to Mr. Dingell, as I have made to Mr. Barton and everyone else, this legislation ought to be on this floor and it ought to be on the floor today. It is truly bipartisan. There ought to be a consensus to go where the science takes us. And again, an advisory committee, a Blue Ribbon panel that would be configured under this legislation would finally end, hopefully, this contentious debate and tell us what it is and what it is not.
I have known dozens of people who have had chronic Lyme. Now, you might say it doesn't exist, the Infectious Disease Society says it doesn't exist. These victims suffer from the spirochete, and have suffered neurological damage, severe joint damage, and many, many other problems.
There is a new book called ``Cure Unknown'' that I would recommend to the House. I read it in one sitting because it is so incisive in finally breaking through the fog on this disease. People are walking around with Lyme and they don't even know it.
We need to bring the forces to bear of the U.S. Government that an advisory committee of this kind would do a Blue Ribbon panel, a 9/11-type panel of scientists, of the best people we can put together to say, put aside the egregiously flawed Infectious Diseases Society of America's finding, which Blumenthal said was riddled with conflict of interest--and I urge Members to read Blumenthal's opinion, I will put it in the Record so Members can read it--his findings were, ``atrocious, conflict of interest everywhere.''
This legislation ought to be on the floor and it ought to be on the floor today.
OFFICE OF THE ATTORNEY GENERAL,
Hartford, Connecticut, May 1, 2008.
Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter
Attorney General Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Infectious Diseases Society of America's (IDSA) process for writing its 2006 Lyme disease guidelines and the IDSA has agreed to reassess them with the assistance of an outside arbiter.
The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by nsurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions.
Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent.
``This agreement vindicates my investigation--finding undisclosed financial interests and forcing a reassessment of IDSA guidelines,'' Blumenthal said. ``My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA's guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.
``The IDSA's Lyme guideline process lacked important procedural safeguards requiring complete reevaluation of the 2006 Lyme disease guidelines--in effect a comprehensive reassessment through a new panel. The new panel will accept and analyze all evidence, including divergent opinion. An independent neutral ombudsman--expert in medical ethics and conflicts of interest, selected by both the IDSA and my office--will assess the new panel for conflicts of interests and ensure its integrity.''
Blumenthal's findings include the following: The IDSA failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel;
Subsequent disclosures demonstrate that several of the 2006 Lyme disease panelists had conflicts of interest;
The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA's oversight committee;
The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group's position on chronic Lyme disease to achieve ``consensus'';
The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded;
The IDSA portrayed another medical association's Lyme disease guidelines as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.
IDSA has reached an agreement with Blumenthal's office calling for creation of a review panel to thoroughly scrutinize the 2006 Lyme disease guidelines and update or revise them if necessary. The panel--comprised of individuals without conflicts of interest--will comprehensively review medical and scientific evidence and hold a scientific hearing to provide a forum for additional evidence. It will then determine whether each recommendation in 2006 Lyme disease guidelines is justified by the evidence or needs revision or updating.
Blumenthal added, ``The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests--in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies--to exclude divergent medical evidence and opinion. In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards.
``Our investigation was always about the IDSA's guidelines process--not the science. IDSA should be recognized for its cooperation and agreement to address the serious concerns raised by my office. Our agreement with IDSA ensures that a new, conflicts-free panel will collect and review all pertinent information, reassess each recommendation and make necessary changes.
``This Action Plan--incorporating a conflicts screen by an independent neutral expert and a public hearing to receive additional evidence--can serve as a model for all medical organizations and societies that publish medical guidelines. This review should strengthen the public's confidence in such critical standards.''
THE GUIDELINE REVIEW PROCESS
Under its agreement with the Attorney General's Office, the IDSA will create a review panel of eight to 12 members, none of who served on the 2006 IDSA guideline panel. The IDSA must conduct an open application process and consider all applicants.
The agreement calls for the ombudsman selected by Blumenthal's office and the IDSA to ensure that the review panel and its chairperson are free of conflicts of interest.
Blumenthal and IDSA agreed to appoint Dr. Howard A. Brody as the ombudsman. Dr. Brody is a recognized expert and author on medical ethics and conflicts of interest and the director of the Institute for Medical Humanities at the University of Texas Medical Branch. Brody authored the book, ``Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry.''
To assure that the review panel obtains divergent information, the panel will conduct an open scientific hearing at which it will hear scientific and medical presentations from interested parties. The agreement requires the hearing to be broadcast live to the public on the Internet via the IDSA's website. The Attorney General's Office, Dr. Brody and the review panel will together finalize the list of presenters at the hearing.
Once it has collected information from its review and open hearing, the panel will assess the information and determine whether the data and evidence supports each of the recommendations in the 2006 Lyme disease guidelines.
The panel will then vote on each recommendation in the IDSA's 2006 Lyme disease guidelines on whether it is supported by the scientific evidence. At least 75 percent of panel members must vote to sustain each recommendation or it will be revised.
Once the panel has acted on each recommendation, it will have three options: make no changes, modify the guidelines in part or replace them entirely.
The panel's final report will be published on the IDSA's website.
ADDITIONAL FINDINGS OF BLUMENTHAL'S INVESTIGATION
IDSA convened panels in 2000 and 2006 to research and publish guidelines for the diagnosis and treatment of Lyme disease. Blumenthal's office found that the IDSA disregarded a 2000 panel member who argued that chronic and persistent Lyme disease exists. The 2000 panel pressured the panelist to conform to the group consensus and removed him as an author when he refused.
IDSA sought to portray a second set of Lyme disease guidelines issued by the American Academy of Neurology (AAN) as independently corroborating its findings. In fact, IDSA knew that the two panels shared key members, including the respective panel chairmen and were working on both sets of guidelines at the same time--a violation of IDSA's conflicts of interest policy.
The resulting IDSA and AAN guidelines not only reached the same conclusions regarding the non-existence of chronic Lyme disease, their reasoning at times used strikingly similar language. Both entities, for example, dubbed symptoms persisting after treatment ``Post-Lyme Syndrome'' and defined it the same way.
When IDSA learned of the improper links between its panel and the AAN's panel, instead of enforcing its conflict of interest policy, it aggressively sought the AAN's endorsement to ``strengthen'' its guidelines' impact. The AAN panel--particularly members who also served on the IDSA panel--worked equally hard to win AAN's backing of IDSA's conclusions.
The two entities sought to portray each other's guidelines as separate and independent when the facts call into question that contention.
The IDSA subsequently cited AAN's supposed independent corroboration of its findings as part of its attempts to defeat federal legislation to create a Lyme disease advisory committee and state legislation supporting antibiotic therapy for chronic Lyme disease.
In a step that the British Medical Journal deemed ``unusual,'' the IDSA included in its Lyme guidelines a statement calling them ``voluntary'' with ``the ultimate determination of their application to be made by the physician in light of each patient's individual circumstances.'' In fact, United Healthcare, Health Net, Blue Cross of California, Kaiser Foundation Health Plan and other insurers have used the guidelines as justification to deny reimbursement for long-term antibiotic treatment.
Blumenthal thanked members of his office who worked on the investigation--Assistant Attorney General Thomas Ryan, former Assistant Attorney General Steven Rutstein and Paralegal Lorraine Measer under the direction of Assistant Attorney General Michael Cole, Chief of the Attorney General's Antitrust Department.
CONGRESS OF THE UNITED STATES,
Washington, DC, May 18, 2007.
Hon. FRANK PALLONE, Jr.,
Chairman, Subcommittee on Health, House Committee on Energy and Commerce, Washington, DC.
DEAR CHAIRMAN PALLONE: As co-chairs of the congressional L.yme Disease Caucus, we are writing to respectfully request that you mark-up and report H.R. 741 or find a suitable legislative vehicle to attach significant provisions of this desperately needed legislation.
H.R. 741, the ``Lyme and Tick-borne Disease Prevention, Education, and Research Act of 2007,'' would work toward goals for the prevention, accurate diagnosis, and effective treatment of Lyme disease and would authorize an increase in total research and education funding of $20 million per year over 5 years. The bill contains numerous measures to help ensure that resources are expended effectively to provide the most benefit to people with Lyme and other tick-borne diseases.
Introduced in January, this legislation currently has 77 bipartisan co-sponsors. It is supported by more than 60 Lyme disease organizations across the country. This legislation holds the promise to significantly improve the lives of the large numbers of Americans living with Lyme, as well as other tick-borne diseases, and their families and friends.
Lyme is the most prevalent vector-borne disease in the United States today. More than 220,000 Americans develop Lyme each year. According to the Centers for Disease Control & Prevention (CDC), only 10 percent of cases that meet its surveillance criteria are reported. Cases that fall outside the surveillance criteria are not even considered anywhere statistically.
If not diagnosed and treated early, Lyme disease can lead to chronic illness and can affect every system in the body, including the central nervous system and cardiac systems. Later symptoms of Lyme disease include arthritis, neurological problems, such as facial paralysis, encephalopathy, memory problems, weakness of the extremities, seizures, heart block and inflammation of the heart muscle, and even blindness.
In recent years, Lyme disease has continued an upward trend in endemic areas and also has expanded into more areas. Reported Lyme cases increase, by 100 percent from 1992 to 2004 according to CDC. Currently, all states except Montana have reported cases of Lyme disease. It even has been reported that Montana residents have gone outside of the State and tested positive for Lyme). It is far more common than all other insect-borne diseases. Now other diseases are being carried by the same ticks: babesiosis, naplasmosis, encephalitis, perhaps bartonelliosis.
While the emergence of Lyme disease in the Northeastern and mid-Atlantic states has been linked to reforestation, climate change also is an infuencing factor. According to a November 2005 report by the Center for Health and the Global Environment at the Harvard Medical School, ``Climate Change Futures: Health Ecological and Economic Dimensions,'' Lyme disease is spreading in North America and Europe as winters warm, ......'' In areas where Lyme disease is already present, warming temperatures may increase the density of ticks by increasing off-host survival.
Over the past decade and with the increase in Lyme cases, problems with diagnosis and treatment of Lyme disease have become much more visible--affecting larger numbers of people over longer periods of time. We have become increasing concerned with reports of patients who go long periods of time before getting a definitive diagnosis due to the lack of a gold standard diagnostic test and who received delayed or inappropriate treatment because of the lack of treating physicians nationwide and lack of physician education. Many patients lose their jobs and must apply for disability.
In consideration of these conditions the Federal investment in Lyme is surprisingly small--$5.4 million at CDC and $24 million at NIH in FY 2006, actual reductions at both agencies since 2004. While funding levels are a means to an end, the ultimate goal is to put an end to patients having their illnesses and disabilities greatly exacerbated by the lack of accurate diagnostics and effective treatments. H.R. 741 addresses this goal by directing HHS to work toward development of a sensitive and accurate diagnostic test improved surveillance and prevention and clinical outcomes research to determine the long-term course of illness and the effectiveness of treatments. In addition, the bill would establish a Tick-Borne Disease Advisory Committee to ensure communication and coordination among federal agencies, medical professionals, and patients/patient advocates. The Lyme conmunity has been seeking this voice for a decade.
As Chairman of the Energy and Commerce Committee, we know that you share our commitment to significantly improve the health outlook for all citizens of this country, including the hundreds of thousands of Americans who have experienced or will experience the too common occurrence of being bitten by Ivodes scapularis, the deer tick or black legged tick, and contracting Lyme disease. Now Amblvomma americanum, the lone star tick, is rapidly spreading throughout the country from its former more southern habitat, and states in the northeast are beginning to feel its impact as it spreads STARI, a Lyme like illness with the same symptoms as Lyme disease. It also carries Ehrliehiosis or tularemia. Scientists are saying that this lone star is aggressive and will pursue people from 30 feet away, not like the deer tick which wants for its prey sitting on vegetation.
To ensure that these necessary goals are not lost, we respectfully request that you schedule for a mark-up the Lyme and tick-borne Disease Prevention, Education, and Research Act of 2007 H.R. 741. If you have any questions on this matter, please do not hesitate to contact us.
Sincerely,
Christopher H. Smith,
Member of Congress.
Tim Holden,
Member of Congress.
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