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The above template was added without the promised discussion on the talk page. Please add discussion: newborn screening is carried out in nations with adequate health care systems, not those with inadequate health care systems, so your ideas on how to expand discussion of newborn screening to areas in which it is not carried out would be most enlightening. - Nunh-huh 02:13, 20 Oct 2004 (UTC)

Contents 1 == 1.1 reason for reversion 1.2 Paragraphs removed 1.3 Suggested change to "Expanded Screening and Expanded Controversies"

[edit] ==

Nice article start. What is tale of 2 zacharys? I am guessing it is a story of 2 children with the same obscure metabolic disease, one of whom was born in a state that screened and the other born in a state that didn't screen for it and the latter suffered the effects of the disease while the screening detection allowed the second to be treated early. I am assuming the story is being propagated by an advocacy group trying to persuade a state to expand its mandated screening list? I suppose we could make up such a story, which may have been invented anyway by a reporter or advocacy group, but I don't think it's worth a separate article. Why don't we just explain why the states don't all do the same tests and what some of the political controversies are? If I am completely off base in my guesses, please outline or reference the story. Alteripse 10:36, 1 Jul 2004 (UTC)

No. You've got it exactly right. Let me dig up a couple of links--it's a true story unfortunately. You're right, it's probably a paragraph in this article, not an article of its own. Not sure which group is publicizing it, but it's probably someone. jengod 17:27, Jul 1, 2004 (UTC)

A Drop of Blood Saves One Baby; Another Falls Ill (Wall Street Journal {PDF})

Missing the Sign: Lack of Standardized Testing Leaves Some Newborns at Risk (ABC News)

[edit] reason for reversion

Anonymous contributor changed text to: "would anyone be reluctant to support the new, expanded screening programs? As the number of diseases included within the screening panel has increased, the cost to follow up potential positive cases has risen dramatically. If one assumes that state budgets for child health are constrained and finite, dollars spent on additional testing for false positive screen results exceed the costs saved by identifying a true positive cases and reduces resources available to other potentially lifesaving programs such as care for the uninsured or liability insurance for infant immunizations. The issue may be determined by juries deciding whether hospitals must routinely offer expanded newborn screening or risk multimillion dollar malpractice verdicts. Can another US$15-50 for each newborn infant be added to the cost of care or obtained from the state legislatures?" The problem with this is that it makes claims that are more specific for the cost with no back up evidence. The fundamental problem is not an increasing cost for false positives, but our expanding capacity to detect ever rarer diseases. The math for a break-even program has to show that cost saved for hospital or institutional care prevented, and that person's potential productivity will pay for the costs of testing X thousand babies at Y dollars apiece (including of course dealing with false positives). The math is very favorable for the relatively common and fairly treatable diseases like hypothyroidism and galactosemia, but as the disease gets rarer, or the treatment gets less effective or more expensive, the math becomes a net cost. We can certainly advocate that our society privilege children with these diseases in a way that it does not for many more common diseases, but we at least need to examine both the economic and social justice issues openly before simply demanding it as a state service. Your changes focusing on false positives miss this important point. Also, I think the costs for extended testing already in the article are more accurate, but am open to evidence on all these points. Please become a named user and we can discuss it. alteripse 00:24, 30 May 2005 (UTC)

[edit] Paragraphs removed

I received a complaint on my talk page about the same issue Alteripse mentioned above. (I didn't author the content in question, but I did make the most recent change to the page, which presumably is why the anon contacted me.) I've looked at the paragraphs, and I agree that they seem unencylopedic. I've moved two paragraphs from the article to below, in case anybody wants to argue for their re-inclusion. --Arcadian 01:45, 5 January 2006 (UTC)

Newborn screening tests have become a subject of political controversy in the last decade. It is difficult to resist the appeal of screening when a single child injured by a treatable disease can be shown to the news media and legislature. A prime recent example is the so-called "tale of the two Zacharys." Two California babies, Zachary Wyvill and Zachary Black, were both born with Glutaric acidemia type I. Wyvill's birth hospital only tested for the four diseases mandated by state law, while Black was born at a hospital that was participating in an expanded testing pilot program. Black's disease was treated with diet and vitamins; Wyvill's disease went undetected for over a year, and during that time the damage from the enzyme deficiency became irreversible. Birth-defects lobbyists pushing for broader and more universal standards for newborn testing are using the tale of the two Zacharys as powerful persuasion.

Why would anyone be reluctant to support the new, expanded screening programs? As the number of diseases and their rareness has increased, the cost to screen each infant and the cost to detect each case has risen dramatically. If one assumes that state budgets for child health are constrained and finite, dollars spent detecting the 1-in-a-million diseases exceed the costs saved by treating it and reduce resources available to other potentially lifesaving programs such as care for the uninsured or liability insurance for infant immunizations. The issue may be determined by juries deciding whether hospitals must routinely offer expanded newborn screening or risk multimillion dollar malpractice verdicts. Can another US$50-100 for each newborn infant be added to the cost of care or obtained from the state legislatures?

If you look at the article history, I wrote those paragraphs in response to a request from user:jengod to cover the "story of the 2 Zacharies". This is one of the most important controversies about newborn screening right now, at least in the US: the fact that the programs are run at state levels and therefore are not all the same in the 50 states. What is "unencyclopedic" about them? Are you complaining about the accuracy? Are you a partisan of one view and believe the other does not deserve description? I consider it fairly discourteous to simply remove valid and important info with no better explanation than "unencyclopedic". alteripse 01:51, 5 January 2006 (UTC)

I ask you to assume good faith. I didn't delete the content; I moved it to the talk page in case anybody wanted to discuss it. If you want to keep the content, it's no skin off my nose. But I do ask that you take care when you revert -- you changed more than you thought you did. --Arcadian 02:47, 5 January 2006 (UTC)

OK, I don't doubt it was in good faith, but what seemed rude was the lack of explanation: "unencyclopedic" is not exactly obvious. I am certainly willing to respond to questions or suggestions or modify (which is exactly where those paragraphs came from in the first place), but there was nothing to respond to except a removal. So I responded to that. alteripse 03:12, 5 January 2006 (UTC) And you are right, the other change I removed was a good one.

But why did you remove the list of the five disorders currently tested in every state? from December 9th? It's still missing in your most current edit. --Arcadian 03:31, 5 January 2006 (UTC)

Because I screwed up. There I think it is fixed with everything by anybody restored. Now could we all discuss proposed deletions before doing it? alteripse 03:53, 5 January 2006 (UTC)

We're not totally back to the December 9th version, but it's good enough, and I think we'll both agree that the one major change ("In the United States, there...") is an improvement. If you do want to take a look at the two paragraphs in question, my concerns (and presumably those of the anon) were with the rhetorical questions, the unsourced numbers, and the presumption of motivations. But I will refrain from further edits on that section (at least for the next year or so), and I'll defer the judgement of others to determine that content. --Arcadian 04:14, 5 January 2006 (UTC)

Your complaint is that rhetorical questions are unencyclopedic? Really? That was it? Fine, rewrite them in declarative style if you wish. And what about motivations: those who want to expand mandatory screening think the cost is worth it to save children from rarer and rarer diseases; those who have not voted to expand screening have not been convinced the dollar value matches the dollar cost, or that all the standard conditions for a screening program have been met, or that there are higher priorities for spending health department budgets-- they are not evil motivations. The third position is that in the US healthcare system a couple of jury verdicts can literally make policy (not necessarily rational policy) regardless of what elected legislatures might choose. I can understand both sides; when I was on one of the state newborn screening advisory committees I voted to extend screening. Whose motivation do you think I am misrepresenting? There are no unsourced numbers in those paragraphs-- the 1 in a million is simply an asymptotic example point toward which detection of ever-rarer diseases moves, not an actual disease. So what number do you want a source for? alteripse 04:32, 5 January 2006 (UTC)

[edit] Suggested change to "Expanded Screening and Expanded Controversies"

From the anon who commented to Arcadian on 1/4/06 now User:Pleidies

I read the exchange on this talk page and appreciate the discussion. Please review the following draft and consider updating the section "Expanded Screening and Expanded Controversies." (I have hard copy sources for both of the two California stats but could not find links to them online). Comments, questions, edits and additional dicussion are welcome.

..................

Why would anyone be reluctant to support the new, expanded screening programs? Instituting MS/MS screening often requires a sizable up front expenditure. When States choose to run their own programs the initial costs for equipment, training and new staff can be significant. The State of California required $15M in FY 2005 to fund its newborn screening expansion effort.. To avoid at least a portion of the up front costs, some states such as Mississippi have chosen to contract with private labs for expanded screening. Others have chosen to form Regional Partnerships sharing both costs and resources. But for many states, screening is already an integrated part of the department of health which can not be easily replaced. Thus the initial expenditures can be difficult for states with tight budgets to justify in one fiscal year. Screening fees have also increased in recent years as healthcare costs rise and more states add MS/MS screening to their programs. (See Report of Summation of Fees Charged for Newborn Screening, 2001 - 2005) Some argue that dollars spent for these programs may reduce resources available to other potentially lifesaving programs.

However, recent studies suggest that expanded screening is cost effective in the long run (see ACMG report page 94-95 and articles published in Pediatrics here(p1406) and here). Others sources such as Delaware’s Newborn Screening Program and California’s Senate Office of Research are convinced that expanded screening provides a net savings in healthcare costs. Advocates are quick to point out studies such as these when trying to convince state legislatures to mandate expanded screening.

Expanded newborn screening is also causing controversy among some health care providers who worry about the availability of effective treatments, screening accuracy and issues of informed consent (see Financial, Ethical, Legal, and Social Issues)

The issue may ultimately be determined by juries deciding whether hospitals must routinely offer expanded newborn screening or risk multimillion dollar malpractice verdicts. --Pleidies 07:38, 12 January 2006 (UTC)

Hello -- I'm commenting not because I am an expert on this topic, but because Pleidies has requested several times that I weigh in (more details on why are available above.) First, I'd like to commend you on getting an account. People are much more willing to discuss things with people who have accounts, because they can be more confident that they are talking to is the same person they talked to before, which facilitates compromise. I do not know if User:alteripse objects to your proposed changes -- it does not appear that he responded to your inquiries. So my recommendation is that you read Wikipedia:Be bold in updating pages, and then start to make the updates yourself. Make sure you leave good edit summaries describing what you are doing. When you make the change, it will show up on his watchlist, and if he objects to your changes, you should know about it before too long. A couple more suggestions -- take a look at Wikipedia:Policies and guidelines before starting in earnest -- understanding the culture can help people avoid many missteps. And finally, you may want to consider making some edits on less controversial topics before editing this one. Usually when people make changes, the other people watching that page look at the recent contributions of the editor to try to determine if the changes were made in good faith. It is sort of like building up a credit record. Hopefully this is enough to get you started, but if you have any questions or troubles, let me know. --Arcadian 13:00, 12 January 2006 (UTC)

I have no objection to the changes. I just read the long committee report that someone (Arcadian?) appended to the article. It is superb and does a much more thorough job than I did of explaining both sides of the controversy, including examples of screenable diseases with frequencies similar to my 1 in a million example (see, for example, carbohydrate deficient glycoprotein syndrome-- I can name many more). I was planning to expand the section further and will probably further amplify so both the advantages and disadvantages are properly represented. May I suggest you have one misunderstanding and that is you have to be careful about claims of cost-effectiveness. The Delaware State Site has a vague and unreferenced claim about cost-effectivenss that someone wants to insert here. My cautions: first the Delaware site is no more authoritative or worth linking than similar sites from nearly all the other states. Second, and more important, I am not sure where their specific dollar saving came from. If we are going to grant it strong evidence status, we should track the reference down and be sure it was not calculated based on older more restricted test lists (which is my suspicion).

Finally, thanks for setting up an account and bringing up the issues here. alteripse 04:41, 14 January 2006 (UTC)

Please understand that national recommendations for newborn screening do not include carbohydrate deficient glycoprotein syndrome or any other disorders with a 1 in a million frequency. The 53 disorders included in the ACMG Report's recommendations are those for which early detection and intervention provide substantial benefit to the individual, as determined by the ACMG in a 2-year study of evidence gleaned for 83 life-threatening disorders. [1] Note that only 53 were selected from the 83 disorders under scrutiny, and even those are identified in 2 categories.

First, the "core panel" consists of 28 disorders and also hearing screening. Second, the "secondary targets" panel includes an additional 25 disorders, many of which will be detected concurrently with screening for the core panel. The same drops of blood are screened for both panels.

Further, the national recommendations do not extend beyond routine newborn screening that is currently available. In other words, the national recommendations merely lend support to that which newborn screening medical experts have been doing for years: saving lives by screening infants for 50+ disorders. This is not radical science.

Newborn screening through tandem mass spectrometry (MS/MS) has the capability of detecting many more disorders than are recommended, but not even the medical experts with the most experience in MS/MS are promoting screening for disorders with a 1 in a million frequency. The MS/MS machine is programmed to look for specific markers that might indicate the presence of certain disorders included in a state's panel. Coupled with traditional tests for other disorders, MS/MS technology has allowed previously undetectable disorders to be treated in time to provide maximum health benefits for those affected by one or more of the 50+ disorders.

In states that use MS/MS but do not include all of the nationally recommended disorders, the machine has to be programmed to ignore certain results. If a newborn child has a disorder that is indicated but ignored, that baby is then at risk of grave physical and/or mental consequences...or death...that could have been prevented. In the end, it is not the disorder that is ignored, but rather the child with the disorder.

Compassion may have a price, but who among us would choose to tell the parents of a child who suffers because of inadequate newborn screening, "Sorry, your baby did not make the cut." --New Reader, 7:39, 14 January 2006

Your wording suggests you think the article (or perhaps I) present a perspective different from the report, but I fail to see any disagreement. What is your point? alteripse 04:36, 15 January 2006 (UTC)

My point is that references to "1 in a million" in the article under discussion have no bearing on national recommendations for newborn screening, nor to the cost factor of these recommendations. Cost is certainly a consideration where state budgets are concerned, but states are not considering screening for disorders that have a 1 in a million frequency. Thank you for the opportunity to clarify. --New Reader, 6:15, 15 January, 2006

The report was precisely a consideration of possible disorders to screen. The committee made the decision to not recommend screening for 1 in a million diseases, which is exactly the point of the paragraph in the article. The article and the report say the same thing, which is that most reasonable people take frequency and cost per case into account when deciding which tests to mandate and buy with Health Dept budget dollars. The arguments were/are exactly the same for 1 in 10 million frequency or 1 in 100 000 frequency: as the old joke goes, all we would be doing by changing the number is negotiating price. If you prefer one of the those numbers we can change it to one of those numbers but your concreteness baffles me. Why is this hard for you to grasp? alteripse 13:34, 15 January 2006 (UTC)

Really? Exactly the point? Please forgive me for a thought process that is not identical to yours. I am obviously no match for your superior intellect, but I am relieved to know that the committee and the article concur. Thank you for providing the accurate interpretation. --New Reader, 12:35, 15 January, 2006

Forgive my exasperation. I must be the slower one because I still don't understand your point. I wanted the article to convey (in a more concise and lively manner) the same message as the ACMG report, but apparently it does not read that way to you (and maybe someone else but it's hard to tell anonymous comments apart). So please help me understand why. Is mention of a specific number what bothers you? Is it the 1 in a million number--if it said 1 in 100 000 would it seem better or worse? As you mention above, no matter what odds are used to "make a cut" between screened and unscreened diseases, and whether we test for 2% or 80% of screenable diseases, there will always be a baby undetected who might have been if only the screening program had included that disease also. Please help me make the message clearer if you don't think the current wording is clear enough. alteripse 19:19, 15 January 2006 (UTC)

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I've been away for a bit but am very glad to find more discussion on this topic as I return. Alteripse, I appreciate your comments and am glad you "have no objection to the changes." I agree, the Delaware reference is a little thin as it stands and should be left out until it is clear how they came to the numbers in their claim. I'll dig a bit and see what I can find.

In the meantime, I'm going to go ahead and post my update with the Delaware and California references removed.

On the discussion about disorder frequency; the 1 in 1,000,000 comment was one of the things that originally got me interested in requesting an edit to this section. After reading your comments above, I now understand where you are coming from. I understand that, yes, there are some 1 in 1,000,000 disorders out there and some would argue that these should be included while others think they they should not. I suppose we should not ignore this point entirely but, if I understand the current scope of the "controversies" section, the issue at hand is screening by MS/MS. That was certainly the issue with the two zachary's story which you've highlighted. In this context, I think any suggestion of disorder frequency in this section should reflect the disorder frequency of the MS/MS panel, which I understand finds a disorder in 1 in 1,500 babies. To do otherwise would leave the impression that the "1 in 1,000,000" reference is about MS/MS, not additional disorders outside the MS/MS panel.

In the end, I've left out the issue of disorder frequency entirely; my upcoming edit will be silent on the issue. As always, comments, questions, and suggestions are welcome. --Pleidies 01:52, 24 January 2006 (UTC)

Your edits were fine. This year is MS/MS but ten years ago it was 17OHP levels and next year it will be gene arrays. I'd like the article to make clear that we are always negotiating the line and always deliberately excluding some screenable diseases and always dooming some babies to be missed while agreeing to catch some more. The potential screening tests are proliferating faster than we can evaluate them, let alone afford them. You removed my statement about the cost of MS/MS screening-- it went from a hospital cost of about $23 per test in the late 1990s when done by Neogen for hospitals to $89 when Pediatrix bought them and made the same test publicly available. While states can negotiate better prices than that, the entrepreneurial profit angle is a new and not insignificant piece of the controversy and is an important part of the delayed spread of the tests as the state health departments try to figure out alternatives. The only viewpoint that annoys me is the one that says "how could any decent person refuse to mandate this test right now?". alteripse 02:54, 24 January 2006 (UTC)

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You are correct, MS/MS certainly commands today's debate but it is not the end of the line. Perhaps some informed speculation about the future of Newborn Screening would be worth a short segment in this article.

Yes, I put the $89 figure in hoping to make the actual cost of private screening clearer to the reader. A comparison to today's State Screening fees would certainly be appropriate here since screening fees have gone up across the board (not just at the private labs). The important comparison is “what do I get for my money”. If a state charges you $25 but only screens for 4 disorders that’s not much of a bargain. :You missed my point. The charge for the extended tandem mass spec screening was about $23 when offered by Neogen to individual hospitals in the late 1990s. Nearly all hospitals in this state adopted it. When the state was at the point of mandating it, Pediatrix bought Neogen as an opportunity for profit and the price rose substantially for the same test. The price for individuals is now $89. While several factors changed and the two pricings are not wholly comparable, it added another issue that caused a further hesitation in adoption. This was the point when several states looked for other alternative sources of this test. alteripse 12:26, 24 January 2006 (UTC)

I'd also like to suggest a subtle rewording in the opening section on disease qualifications. The consideration of "worth" is very complicated and highly subjective. It strikes me as a bit presumptuous to suggest qualifications that determine whether diseases are "worth screening for". I think the section can and should outline current and historical qualifications without including a judgment about worthiness. Consider: :I think worth is a valid word, but change it for clarity not because someone is squeamish at recognizing that at the heart of the decision is a weighing of dollar cost against lifes saved or improved. alteripse 12:26, 24 January 2006 (UTC)

Common considerations in determining whether to screen for disorders:

1) A simple and reasonably reliable test exists

2) A high enough frequency in the population

3) A treatment or intervention that makes a difference if the disease is detected early

--Pleidies 08:40, 24 January 2006 (UTC)

Well there is more to consider:

• The condition sought should be an important health problem for the individual and community.
• There should be an accepted treatment or useful intervention for patients with the disease.
• The natural history of the disease should be adequately understood.
• There should be a latent or early symptomatic stage.
• There should be a suitable and acceptable screening test or examination.
• Facilities for diagnosis and treatment should be available.
• There should be an agreed policy on whom to treat as patients.
• Treatment started at an early stage should be of more benefit than treatment started later.
• The cost should be economically balanced in relation to possible expenditure on medical care as a whole.
• Case finding should be a continuing process and not a once and for all project.

(Wilson & Jungner 1968) --WS 10:02, 24 January 2006 (UTC)

I agree those are classic and probably worth quoting. I would distinguish them from the 3 simple and primary factors though, since they are essentially implicit in those. alteripse 12:26, 24 January 2006 (UTC)

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On the $89 fee: I understand your point, but want to avoid comparing a current 2006 testing fee to fees charged in the late 1990's. If it went immediately from $23 to $89 then OK. But I'm pretty sure it didn't. Whether or not the introduction of for-profit businesses into newborn screening has independently driven up the cost of screening, or had an adverse effect on expansion efforts, I don't know. An analysis of the fees and other factors over time might help make that point. But let's not forget that for-profit businesses also lead to innovation and efficiencies that State run facilities have little or no incentive to strive for.

On Worth: I simply wish to be cautious about suggesting that some children are worth the (money, effort, time, technology) while others are not. The word "worth" suggests more to me (and I suspect more to the average reader) than just "weighing of dollar cost against lives saved or improved." I'm going to post my proposed edit on that basis. I agree links to additional considerations would be useful. I’d start with a link to page 25 of the ACMG report rather than Wilson Jungner since the later is almost 4 decades old. But I'll leave it alone for now. --Pleidies 22:18, 24 January 2006 (UTC)