Archives for posts with tag: HHS

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive.

National Institute on Drug Abuse[1]

 [This is Fred and I’m here with more bad news about heroin and the other opioids now destroying us, plus some cheerful speculation. Note the paragraph quoted above. Apparently in the 1990s we didn’t understand that opium and its relatives are highly addictive, even though it was obvious 200 years earlier. See our recent blog[2] on Thomas de Quincey’s Confessions of an English Opium Eater.[3] So I guess our great planners didn’t expect patients to start abusing opioids once those drugs became plentiful by prescription. And once more people became addicted certainly no one expected the criminal class to fill the increased demand with their own, informal products. Who would ever dream such a thing?

Also, we still don’t know if opioids actually treat pain when they are used in the long term. According to one recent study: “Evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving chronic pain and function. Evidence supports a dose dependent risk for serious harms.”[4] Translation?  The long term benefits are unclear, but the dangers are obvious.

Not to worry, the National Institutes of Health [NIH], and their parent, the Department of Health and Human Services [HHS] have swung into action. Today society has a problem with opioid addiction and they will solve it by:

  1. Improving access to treatment and recovery services;
  2. Promoting use of overdose-reversing drugs;
  3. Strengthening our understanding of the epidemic through better public health surveillance;
  4. Providing support for cutting-edge research on pain and addiction; [and]
  5. Advancing better practices for pain management.[5]

So what could go wrong? Well, think about it. If we’re going to improve access to “treatment and recovery” services [Point 1], what does that mean? Do we have some magic cure that will wipe away addiction? I don’t think so. It’s very difficult to ween an addict from his [or her] opioid of choice. It was that way for Thomas de Quincey, and the situation hasn’t changed.  And if the weening process takes a long time, that sounds expensive. Taxpayers beware!

OK, but surely it would be a good thing to promote “overdose-reversing drugs.” [Point 2] Yes it would, because those drugs prevent death by overdose and it’s always good to do that. But overdose drugs don’t cure addiction, so we still have the problem of treating the survivors.

All right, then what about Point 3? NIH wants to know more about the size of the problem, how many addicts there are, and so forth. Again, who can quarrel with that? “Knowledge is power,” we’re told;[6] and why rent a rowboat for addicts if we really need a passenger liner? So yes, by all means study the problem, but not at the expense of making progress elsewhere. And by the way, the early returns are in. See Crappy News, the next section.

How about “cutting edge research” [Point 4]; is that a good idea? Practically always, say I. If our scientists research pain, perhaps they’ll develop new ways to treat sufferers without dosing them with addictive substances. That’s got to be a “better practice” [Point 5] than what we’ve been doing.

Then what about “cutting edge research” on addiction itself? Should we work on that as well? Yes, and we’ll discuss that later, under Vaccines.]

The Crappy News, or Why One Should Avoid the Drudge Report Early in the Morning

So the other day I was minding my own business, checking the Drudge Report, when I happened on a piece from Reuters that said: “More than third of [all] U.S. adults [were] prescribed opioids in 2015.[7] [Drudge is my substitute for a morning tabloid; feel free to pick a different service if you want; but definitely we all need something to read at breakfast.]

Ugh? Looking further I found the original data, or at least an abstract of it.[8] Officially the study is called the 2015 National Survey on Drug Use and Health [NSDUH]. So let’s sketch the findings. What else can you do with an Abstract?

  • In 2015 72,600 eligible civilian, noninstitutionalized adults were selected to participate in the study, and 51,200 completed the survey interview.
  • Based on these inputs, NSDUH estimated that, in 2015, 91.8 million (37.8%) of U.S. civilian, noninstitutionalized adults used prescription opioids.
  • 11.5 million people (4.7% of all adults) misused opioids; and 1.9 million (0.8%) had an opioid use disorder.
  • Among adults with a prescription, 12.5% reported they misused it; and of these, 16.7% reported a “prescription opioid use disorder.”
  • Most commonly people who misused opioids did so to relieve physical pain (63.4%). Does that sound familiar? Check out Thomas de Quincy’s story, referenced above.
  • Misuse and use disorders were most common with adults who were uninsured, unemployed, had low income, or had behavioral health problems.
  • Among adults who misused opioids, 59.9% reported using them without a prescription, and 40.8% obtained prescription opioids – for their most recent episode – for free from friends or relatives.[9]

So there you have it. Lots of doctors prescribe opioids; more than one-thired of U.S. adults had prescriptions in 2015; and some of those also used opioids without a prescription. Thank you, NSDUH, for that insight.

And some patients get violent if their doctors refuse to write prescriptions.[10] The states are upset; they argue over-prescription and the resulting addictions are impacting state resources;[11] and they’re beginning to sue the drug companies [and others] they think are responsible. Congress is alert, and will hold hearings on the matter.[12] Mexico is producing more and more opium to satisfy the demand growing in the U.S.[13] [Frankly, I didn’t know Mexico produced any opium; I thought most of the world’s supply came from our dependency, Afghanistan.] And, of course, our medical establishment is studying the problem that, one could argue[14], it created.

Vaccines

None of this is good, but is there sunlight behind the clouds? A month or so ago a friend[15] sent us an article about medicines that fight opioids and other addictive substances.[16] Apparently this has been researched since the 1970s, although without much recent success. Right now therapists have only three medications – methadone, buprenorphine, and naltrexone – to use to help the opioid addicted “get clean” and stay drug free. They work, but “not perfectly.”[17]

Current research is directed toward finding vaccines to directly counter opioid addiction. Most foreign substances are blocked from entering the brain by something called the blood-brain barrier. Opioids are an exception to that. They are very tiny molecules; can penetrate the barrier and enter the brain; and then do their damage unopposed. Opioids may lose their advantage – of small size – if they are attacked by antibodies “that bind to the drug molecules, creating complexes that are too large to cross into the brain.”[18] If the brain isn’t accessed, “there’s no high.”[19] And, one might add, there’s no corresponding brain damage to reinforce later addictive behaviors.

So the research is directed at triggering the human immune system to directly attack opioids. To (i) convert opioids to larger things that will not pass into the brain, or (ii) flush them out of the body before they reach the brain, or (iii) to do both. The Scripps Research Institute in La Jolla, CA, and the Walter Reed Army Institute of Research in Silver Spring, MD, have promising lines of study, and may have vaccines ready to begin human trials in the not too distant future. There are other candidates out there as well.

Conclusion

The situation with opioids is grim and looks worse every day, but perhaps there really is sunlight behind the clouds. The important thing for Congress to remember is that, when they’re throwing oodles of money at law enforcement to chase bad guys with drugs, they shouldn’t forget the scientists who, with funding and a bit of luck, may solve this problem for everybody.

Until the next one comes along, of course. Humans are weak, and our criminals are very ingenious. Didn’t you know?

 

[1] This is from the website of the National Institute on Drug Abuse, an organization within NIH. You can find it at https://www.drugabuse.gov/drugs-abuse/opioids/opioid-crisis . It was last updated in June of this year.

[2] That’s the blog of 07/16/2017, Opium Portrayed, at  https://opsrus.wordpress.com/2017/07/16/opium-portrayed/

[3] That’s Confessions of an English Opium Eater, Being an Extract from the Life of a Scholar. It’s currently in print from the Oxford University Press.  It was first published in 1821 in London Magazine, and was picked up in 1886 by George Routledge and Son. You can find the hard copy on Amazon. However, in keeping with blog policy, we found an alternate, free source for the text, this time in an eBook from Project Gutenberg.  Go to http://www.gutenberg.org/files/2040/2040-h/2040-h.htm .

[4] See Annals of Internal Medicine, The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop (February 17, 2015) at Abstract, available at http://annals.org/aim/article/2089370/effectiveness-risks-long-term-opioid-therapy-chronic-pain-systematic-review .

[5] See n. 1.

[6] See Knowles, Oxford Dictionary of Quotations (6th Ed., 2004) at Proverbs, p. 624, n. 45.

[7] It’s at Reuters Health News, Seaman, More than a third of U.S. adults prescribed opioids in 2015 (July 31, 2017), available at http://www.reuters.com/article/us-health-opioids-prescriptions-idUSKBN1AG2K6 .

[8] The Abstract appears as Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults: 2015 National Survey on Drug Use and Health (August 1, 2017). You have to pay for a copy if you want to read the underlying article. I don’t know why that’s the case, since the study apparently was funded by our government. Anyway, the abstract is available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4782928/pdf/nihms753305.pdf .

[9] These findings are paraphrased or directly quoted from the Abstract.

[10] See, e.g., Fox 5, Hundreds mourn doctor slain after denying opioids to patient (August 2, 2017)), available at http://www.fox5ny.com/news/271464646-story .

[11] See Reuters, Raymond, State attorneys general probe opioid drug companies (June 15, 2017) available at http://www.reuters.com/article/us-usa-opioids-idUSKBN1962JJ

[12] See Clair McCaskill speaking to the DNC on July 28, 2016, available at https://www.bing.com/search?q=hthtps%3A%2F%2Fwww.yahoo.com%2Fnews%2Fu-senator-launches-probe-five-top-opioid-drugmakers-165514279 finance.html&form=EDGEAR&qs=PF&cvid=59500fa1e8204d0a8a8906e8292f9679&cc=US&setlang=en-US&elv=AXXfrEiqqD9r3GuelwApuloTP6wVwkOjONBqpuAMtOReD2p9Vv8km70BwEANJJDGrbYQZQruLL%21jduPgTqpAT%212GMOjDF0L2w7LKJr4QVFIa

[13] See RT, US offers to help fund Mexico’s heroin eradication efforts – report (22 April 2017) available at https://www.rt.com/usa/385656-mexico-fund-heroin-reuters/

[14] In fact, there doesn’t really seem to be an argument about this. See n. 1 and the quote that accompanies it.

[15] That’s Dave Feagles. Many thanks, Dave!

[16] See Science News, Gaidos, Vaccines could counter addictive opioids, Vol. 190, No. 1, p. 22 et seq. (July 9, 2016), While we have this article in our library, we don’t have a web  address for it, so we’re citing to the hard copy magazine.

[17] Id. We’re citing to the print version of the article, but don’t have the printed pages before us. We estimate that this information appears around p. 23.

[18] Id. at around p. 24.

[19] Id.

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I welcome your findings, and commit to full cooperation with your review so that we can gain a full understanding of what led to the failed launch of Healthcare.gov, and take concrete action to avoid such problems in the future.

Kathleen Sebelius, writing to the HHS IG on December 10[1]

How about that? We’re actually starting a blog with a topical quote from a current political figure. They’ll be no 17the Century wisdom this time around. Why not? Well, we’re going to deal with a serious matter, i.e. the Patient Protection and Affordable Care Act[2]. Everybody’s talking about it and we like our quotes fresh if they’re available. It’s like eating. Suppose tonight you had a choice between leftovers or something fresh for dinner. Which would you go for? [Actually, I expect your answer might depend on the cook.]

Anyway, the Affordable Care Act is supposed to open the private insurance markets to millions of people who don’t have health insurance or are under-insured. As we all know, the grand opening of Act was not auspicious. The specially constructed web site, designed to process tens of thousands of customers an hour, didn’t work, and even now limps along at less than an ideal rate. Congress is outraged (we talked about that last week) and the public is alarmed. Could it be that the procurement system somehow was at fault, or, horror of horrors, did the people who worked on the program actually make some mistakes?

Inquiring minds in Congress want to know and so does the Secretary of HHS. So last week she decided to call for help. She wrote the HHS IG[3] and basically asked him to review everything, from the principal contractor’s “performance and program management structure” to the “acquisition process,” from beginning to end. She also said she would appoint a “chief risk officer” i.e. a bureaucrat, to oversee risky programs in the future,[4] and increase training for the procurement workforce[5].

I don’t know much about “chief risk officers,” but I’ll bet that somewhere in HHS there’s already somebody responsible for managing technically risky programs. So it doesn’t seem like a bold move to create a new position, especially if you haven’t already rooted out the dunderheads who made the current mistakes. And as far as training goes, most likely the HHS training contractors are eagerly waiting for a slew of new contracts.  Will more training change anything? Who can say? But I would think HHS would wait to find out what went wrong before approving a bunch of new courses. Ideally new training should be targeted to correct current mistakes. There’s no point to being surprised a second time by the same problem, if you can avoid it.

On the other hand, it’s a serious thing to turn an IG loose on a matter. The Inspectors General have been with us in their present form since 1978. They’re set up to be independent of, yet exist within various federal agencies, and their function is to audit and investigate agency programs. Section 12 of the law[6] specifically identifies which agencies [the law calls them federal “establishments”] must have an IG Office. These include the Departments of Agriculture, Defense, Health and Human Services, Justice, Homeland Defense, and many, many others. IGs are appointed by the President and can only be removed by him.[7] Agency heads can’t do it.

So you see, IG investigations are not easily controlled by management, and obviously Secretary Sebelius recognizes that. Look at the quotation at the head of this piece. She’s promised “full cooperation” with the IG. Granted she suggested some management areas the IG might look at, but it doesn’t look as though she intends to restrict his activities to those. If she did, that would be a very odd form of “full cooperation.”

This is important, because the IG wears more than one hat in any investigation. He can be a management consultant, an audit supervisor and all the rest, but at the same time, he’s also a criminal investigator. Section 4 of the law says that an IG must keep the head of his agency and the Congress “fully and currently informed … concerning fraud and other serious problems, abuses, and deficiencies relating to [agency programs.]”[8] And more to the point, the various IGs have developed a list of “tells” that might indicate hanky-panky in the Government. The IGs call these indicators of fraud.[9] See one, and take a further look.

So what kinds of contract actions can attract an IG’s attention? Well, suppose an agency dispenses with competition and awards an important contract to a single source. This is permissible under certain circumstances, but such actions inevitably raise questions. What justification was given? Is it in fact true? Did the appropriate people sign it? What efforts were made to contact other sources? Was information about the Government’s requirements distributed widely to industry, or was it restricted only to the favored source? Were other potential sources offered an opportunity to comment on the requirements and whether they could meet them?[10] And so forth.

How about another example? Well, suppose you have a contract, and contract performance turns out to be an absolute mess. The Government changes its mind about what it wants; the contractor seems all at sea; costs grow; and the end product is very much unsatisfactory. Is there any fraud there?

It depends. To an IG, there are lots of possibilities. The Government is permitted to change its contract requirements after it awards them[11], but it has to “equitably” adjust the contract price if it does. In my experience, generally the adjustment is upward. If there are lots of changes and cost growth, the IG probably will probably take a close look at the circumstances. If there aren’t adequate contract files to support the actions taken, your average investigator will be very suspicious.[12] He (or she) probably will dig in, ask questions, and look for misstatements or falsifications.

This is not to say that anything illegal has happened at HHS or with its implementation of the Affordable Care Act. Nobody here at Elemental Zoo Two has enough facts to allow us to form an opinion (one way or the other) on that. But when Secretary Sebelius invited the HHS IG to take a look at the procurement, she invited a group of people whose job description is to be suspicious. No doubt they’ll ask lots of questions, and anyone who answers needs to understand that it’s not nice to lie to the Government.[13] Anyone pressed for answers, who’s not sure what to say, should call a lawyer.

The rest of us can wait to see what develops. It might be a little, or it might be a lot. Only time will tell.

 


[1] See HHS letter from Karen Sebelius, Secretary, HHS, to D.Levinson, HHS IG, no subject, (dated December 10, 2013). The letter is available at http://www.hhs.gov/healthcare/facts/blog/2013/12/letter-to-inspector-general.pdf

[2] For those of you who want to know, that’s Pub. Law No. 111-148 (March 23, 2010), 124 Stat. 119 – 1025. You can get a [free] copy from the Government Printing Office at http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/content-detail.html  Henceforth we’ll call it the Affordable Care Act.

[3] Who’s that? To find out, See Office of the Inspector General, HHS, About OIG, available at http://oig.hhs.gov/about-oig/index.asp

[4] See HHS.gov/Health Care, Sebelius, Building On Our Progress and Moving Forward: Three Initial Steps (December 11, 2013, available at http://www.hhs.gov/healthcare/facts/blog/2013/12/three-initial-steps.html

[5] See Federal Times, Medici, HHS IG to investigate Healthcare.gov development (Dec. 11, 2013) available at: http://www.federaltimes.com/article/20131211/IT/312110008/Sebelius-HHS-IG-investigate-Healthcare-gov-development

[6] The original version of the Act appears as Pub. Law 95–452, §1, Oct. 12, 1978, 92 Stat. 1101 et. seq. It’s been amended many times. It’s codified at Title 5, Appendix, of the U.S. Code. You can find an up-to-date version of it law at http://www.ignet.gov/pande/leg/igactasof1010.pdf .

[7] That’s in §3(b) of the Act. “An Inspector General may be removed from office by the President. If an Inspector General is removed from office or is transferred to another position or location within an establishment, the President shall communicate in writing the reasons for any such removal or transfer to both Houses of Congress, not later than 30 days before the removal or transfer. Nothing in this subsection shall prohibit a personnel action otherwise authorized by law, other than transfer or removal.”

[8] The full quote, from §4(a)(5) is that the IG must: “… keep the head of such establishment and the Congress fully and currently informed, by means of the reports required by section 5 and otherwise, concerning fraud and other serious problems, abuses, and deficiencies relating to the administration of programs and operations administered or financed by such establishment, to recommend corrective action concerning such problems, abuses, and deficiencies, and to report on the progress made in implementing such corrective action.”

[9] I first ran into this kind of list back in the early 1990’s. See, e.g., Handbook for Fraud Indicators for Contract Auditors (IGDH 7600.3) (March 31, 1993), available at  http://www.dodig.mil/resources/audit/pdfs/igdh7600.pdf These things are periodically updated. See, e.g., The Washington Post, O’Harrow, Fraud Indicators (Nov. 12, 2008), available at http://voices.washingtonpost.com/government-inc/2008/11/fraud_indicators.html Today the DoD posts this kind of material on that IG’s website. See Office of the Inspector General, DoD, Fraud Investigation Resources, available at http://www.dodig.mil/resources/fraud/index.html

[10] These questions are patterned on a list developed by the IG for USAID. See Office of the Inspector General, Investigations, USAID, Fraud Indicators (no date), available at http://oig.usaid.gov/sites/default/files/fraud_awareness_handbook_052201.PDF

[11] Most federal contracts have some form of a “Changes” clause that allows the Government to do this. See, e.g., Federal Acquisition Regulation (FAR) 43-2, Change Orders. You can get a good copy of the  FAR at https://acquisition.gov/far/

[12] Why can’t we all just trust one another? Consider the following scenario from page 25 of the USAID IG Manual: “Scheme: A company bidding on a contract, in collusion with personnel from the requesting organization submits a low bid to ensure receiving the contract award. However, the company has been assured that change orders will be issued during the life of the contract to more than compensate for the low bid. After the contract is awarded, the contractor and the procuring official share in the excessive reimbursements resulting from the numerous and/or high dollar value change orders issued against the contract.” See note 9. From the IG viewpoint, it pays to be suspicious.

[13] See, e.g., 18 U.S.C. . You can find a more or less up-to-date copy of this statute at http://www.law.cornell.edu/uscode/text/18/1001