Princess Health andHeroin bill finally passes and is signed into law; Naloxone program put into motion; dating-violence bill sent to Beshear.Princessiccia

Princess Health andHeroin bill finally passes and is signed into law; Naloxone program put into motion; dating-violence bill sent to Beshear.Princessiccia

drug abuse drug treatment drugs General Assembly heroin legislation violence women's health

Gusty 20:54 Add Comment

By Melissa Patrick
Kentucky Health News

The long-negotiated bill to tackle Kentucky's heroin-overdose epidemic passed in the final hours of the 2015 legislative session.

Almost immediately after the heroin bill passed the Senate, a bill to offer immediate civil protections to dating partners who are victims of dating violence was passed after being held in the chamber since February 13 -- likely because Democratic Rep. John Tilley of Hopkinsville, chair of the House Judiciary Committee, was the original sponsor of both bills.

Tilley told reporters that the passage of the two bills meant it had been a successful session.

Gov. Steve Beshear signed the heroin legislation, Senate Bill 192, into law Wednesday, March 25, less than 12 hours after it passed, so that its emergency clause could put it into effect immediately. The dating violence bill, House Bill 8, has been delivered for his signature.

"Senate Bill 192 is tough on traffickers who bring these deadly drugs into our communities, but compassionate toward those who report overdoses or who admit they need help for their addiction," Beshear said in a release. "I applaud our legislators for putting aside partisan interests for the greater good of all Kentuckians who have been affected by this devastating drug."

The bill passed the Democrat-controlled House 100-0 and the Republican-controlled Senate 34-4. Republican senators John Schickel of Union, Joe Bowen of Owensboro, Chris Girdler of Somerset and Paul Hornback of Shelbyville voted against it.

The stickiest issues were a needle-exchange program, which many senators opposed, and tough new penalties for drug traffickers, which Tilley and many House members said would not be effective. The new law allows needle-exchange programs of approved by local governments, and the tough penalties, but allows the judge to be lenient in sentencing if the defendant is an addict.

The bill also allocates money for drug treatment programs; includes a "good Samaritan" provision that allows a person to seek medical help for an overdose victim and stay with them without fear of being charged; access for addicts and their families to the drug Naloxone, a drug that reverses the effects of an overdose; and allows the Department of Corrections to provide an approved medication to inmates to prevent a relapse in their addiction.

"The bill includes provisions that are important to law enforcement and me: increasing penalties for large volume traffickers, expanding access to treatment, and getting heroin overdose reversal kits into the hands of our first responders. I know this legislation will save lives," Attorney General Jack Conway said in a news release.

Hornback argued that "forced rehab doesn't usually work," providing addicts with Naloxone and free needles simply enables them and the bill does not allow addicts any "consequences for their actions."

He said that while he knows there are people dying from heroin overdoses,"I didn't make that decision for them and I for one, and a lot of my constituents are tired of paying for people's bad decisions and that is what this (bill) does."

Tilley said in an interview after the vote that needle exchange programs are proven to work, will save taxpayers money and are absolutely necessary to "stem the tide of two tidal-waves that are headed Kentucky's way: HIV and Hepatitis C and Hepatitis B."

"The cost of treating someone with HIV is $350,000. The cost of treating someone with Hepatitis C is $85,000. The budget now had a $55 million hit just with the explosion of Hepatitis C last year. We can't afford that in Kentucky," he said. Advocates say the programs can be a gateway to treatment and rehabilitation.

Meanwhile, Conway and first lady Jane Beshear announced that funding for Naloxone kits would be made available to the hospitals in Kentucky with the highest rates of heroin overdose deaths. The kits will be provided free to every treated and discharged overdose victim at the pilot-project hospitals.

They made the announcement at the University of Louisville, which treated 588 people in 2013 for heroin overdoses, a news release said. In 2013, the latest data available, 230 of the 722 autopsied overdose deaths, or 32 percent, were caused by heroin, according to the Kentucky Office of Drug Control Policy.

Tilley and Republican Sen. Whitney Westerfield, also of Hopkinsville, "forged a friendship that allowed the two men to work out differences on a pair of high profile bills fraught with political pitfalls," Adam Beam reports for The Associated Press. "Westerfield, a former prosecutor, is running for attorney general against the son of Democratic Gov. Steve Beshear, giving Democrats all the reason in the world not to work with him."

The AP notes that Republican Sen. Chris McDaniel wrote the first draft of the heroin bill that passed the Senate in January, but it omits McDaniel's other role: candidate for lieutenant governor on a slate headed by Agriculture Commissioner James Comer. As the Senate prepared to give the final bill final passage, Republican Floor Leader Damon Thayer accused the House of not passing McDaniel's bill because of his candidacy.

Read more here: http://www.kentucky.com/2015/03/25/3767938_political-compromises-brokered.html?rh=1#storylink=cpy

Princess Health andCounty Health Rankings look familiar, but show that some counties overcame bad factors to have encouraging outcomes.Princessiccia

Princess Health andCounty Health Rankings look familiar, but show that some counties overcame bad factors to have encouraging outcomes.Princessiccia

Gusty 14:25 Add Comment

The 2015 County Health Rankings for Kentucky, compiled by the University of Wisconsin Population Health Institute in collaboration with the Robert Wood Johnson Foundation, have been released. For the fourth year in a row, Oldham County ranked highest in Kentucky for health outcomes. Statistical differences among closely ranked counties are very small, so rankings are arranged in quartiles (quarters) in the maps below.

The rankings fall into two categories: factors and outcomes. Health factors, left, include the health behaviors (with factors such as adult smoking), clinical care (with factors such as the ratio of population to primary-care physicians), social and economic factors (such as the percentage of children under 18 in poverty) and physical environment (with factors such as the percentage of workforce that drives alone to work). Oldham County was followed by Boone, Woodford, Scott and Anderson counties. Clay County ranked last, preceded by Martin, Leslie, Wolfe and Knott. Generally, health factors and outcomes reflect income and education levels.

Health outcomes, right, include premature death, poor or fair health, poor physical health days, poor mental health days and low birthweight. Boone County ranked first, followed by Oldham, Shelby, Fayette and Jessamine. Owsley County ranked last, preceded by Floyd, Leslie, Clay and Perry.

Some counties, such as Morgan and Wayne, overcame their poor health factors to have better-than-average outcomes. To see the full, specific list of county rankings, click here.

Princess Health and Two New Independent Reports on the Death of Dan Markingson, But Now What Will Happen? . Princessiccia

Princess Health and Two New Independent Reports on the Death of Dan Markingson, But Now What Will Happen? . Princessiccia

anechoic effect AstraZeneca atypical anti-psychotics clinical trials conflicts of interest manipulating clinical research research subjects suppression of medical research University of Minnesota

Gusty 13:53 Add Comment

Years after his death, there is now a little more clarity about the clinical trial in which Dan Markingson was enrolled when he died.  Whether this clarity will have any impact remains to be seen.

We most recently posted about the aftermath of Mr Markingson's death here, (and see posts in 2013 here, and in 2011 here.)  Very briefly, Mr Markingson was an acutely psychotic patient enrolled in a drug trial sponsored by Astra Zeneca at the University of Minnesota.  His enrollment was said to be voluntary although at the time he enrolled he had been under a stayed order that could have involuntarily committed him to care.  Despite his mother's ongoing and vocal concerns that he was not doing well on the study drug and under the care of trial investigators, he continued in the trial until he died violently by his own hand.  After his death, his mother Mary Weiss, friend Mike Howard, and University of Minnesota bioethics professor Carl Elliott campaigned for a fair review of what actually happened.  University managers not only rebuffed their concerns, but harshly criticized Professor Elliott, and ended up reprimanding him for "unprofessional conduct."

Two New Reports

In the last few weeks, two new independent reports on the case appeared.  Both vindicated the concerns and questions raised by Mary Weiss, Mike Howard, and Prof Elliott.

Association for Accreditation of Human Research Protection

One, called for by the University of Minnesota faculty senate, was by the Association for Accreditation of Human Research Protection,  and said that the university left research subjects "susceptible to risks that otherwise would be avoidable" (see this Minneapolis Star-Tribune article.)  Furthermore, according to a post in the Science Insider blog from the American Association for the Advancement of Science, it said,

[T]he external review team believes the University has not taken an appropriately aggressive and informed approach to protecting subjects and regaining lost trust,

Also, it said the university has been

assuming a defensive posture. In other words, in the context of nearly continuous negative attention, the University has not persuaded its critics (from within and outside the University) that it is interested in more than protecting its reputation and that it is instead open to feedback, able to acknowledge its errors, and will take responsibility for deficiencies and their consequences.

Finally, it noted a "climate of fear" in the Department of Psychiatry.

Office of the Legislative Auditor for the State of Minnesota

The second report, available in full here,was from the Office of the Legislative Auditor for Minnesota.  If anything, it was more damning. Its summary included,

the Markingson case raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge. They have repeatedly claimed that clinical research at the University meets the highest ethical standards and dismissed the need for further consideration of the Markingson case by making misleading statements about past reviews. This insular and inaccurate response has seriously harmed the University of Minnesota�s credibility and reputation.

It seemed to affirm in detail nearly all of Weiss', Howard's and Elliott's concerns.  It recommended that the University should suspend new psychiatric drug trials until the problems it identified were remedied (see Star-Tribune article here.)

Vindication, but Will It Lead to Progress?  

Taken together, these reports vindicate the work of Mr Markingson's mother, friend, and academic watchdog Professor Elliott and their supporters.  As the Star-Tribune reported,

'Over the past eleven years the University of Minnesota has made us feel as if we have no voice, no rights and absolutely nothing remotely called justice,' wrote Mike Howard, a close friend to Markingson�s mother, in a letter in the audit. 'This report is the first step toward accountability.'

The Minnesota Post added the response of Professor Elliott and a colleague,

'It�s nice to have an independent confirmation of what we�ve been telling the university for five years, but which they have refused to listen to,' he told MinnPost on Thursday.

Elliott said he is not convinced, however, that Kaler and other university leaders are going to take responsibility for what happened in the Markingson case � or take the necessary steps to fix the problem going forward.

'One of the most worrying findings in the report was the widespread belief on campus that the university leadership doesn�t care about human study subjects,' he said.

Leigh Turner, another U bioethicist who has also been outspoken about the issues raised by the Markingson case, expressed similar concerns. 'Can we expect reform from the very people who have done nothing for the past several years?' he said in a phone interview.

'I hope there�s some change,' he added. 'But the fact that [Markingson died in 2004] and it�s now 2015, I think hope has to be tempered with a dose of realism. There are some very powerful forces interested in minimizing the findings and suggesting that there are only minor things that need to be done.'

It appears there a several major remaining questions.

What Were the Underlying Causes?

Although both reports went into some detail about what happened to Mr Markingson, they seemed not to dwell on why it happened.  They did not seem to address relevant contextual factors, policies, and decisions.  For example, the report by the Office of the Legislative Auditor included,

We understand that the University of Minnesota has been and should continue to be an institution that delivers not only high quality medical care but also engages in cutting edge medical research� research that does pose risks to human subjects. In addition, we do not question the appropriateness of the University obtaining money from pharmaceutical and other medical companies to support that research. However, in every medical research study�whether supported with public or private money�the University must always make the protection of human subjects its paramount responsibility.

However, as we and many others more erudite have discussed frequently, clinical research that evaluates products or services made by the commercial sponsors of the research has proven to be highly susceptible to manipulation by these sponsors to increase the likelihood that the results will serve marketing purposes, and suppression if the manipulation fails to produce the wanted results.  Commercial sponsors often strongly influence the design, implementation, analysis and dissemination of clinical research.  Often their influence is mediated by financial relationships with individual researchers and with academic institutions who seem more and more beholden to outside sponsors, that is, by conflicts of interest.  The report by the Auditor noted pressures, including financial pressures on the physician who ran the study in which Mr Markingson was a subject to enroll more patients and keep them enrolled.  To protect patients better in the future, in my humble opinion the relationships among commercial sponsors, academic medical institutions, and individual researchers need further consideration.  Is the easy money supporting research coming from commercial firms with vested interests in the outcome of that research really worth the risks of biased results, hidden results, and to research subjects?   

Will Anything Change and Will Anyone be Held Accountable?

Once these two reports were delivered, it now seems to be up to university managers to make needed changes.  In general, these are the same managers who are described above as so "defensive," who not only ignored complaints, but appeared to try to silence those who complained.  If they are left in charge, why should we expect them to make any meaningful changes?  Instead, should they  not be held accountable for their actions?  

Will the University Cease Hostilities Against Dr Elliott?

Again, as noted above, university managers did not merely disagree with Professor Elliott.  They disparaged him, appeared to try to intimidate him, and reprimanded him.  It seems at the very least he is owed an apology.  So far, nothing in the news coverage suggests he has or will receive one.

Will Anyone Notice? 

So far, this case has gotten good coverage in Minnesota media.  However, it has largely been ignored in the national media.  Beyond Minnesota, I could only find mention in some blogs, e.g., in PharmaLot by Ed Silverman, and in Forbes by Judy Stone.  I have seen nothing in any US medical or health care journal, although the British Medical Journal did cover it in a news feature.  This case clearly has global implications, and ought to be considered one of the most important cases illustrating the perils of commercially sponsored human research, but it remains proportionately anechoic.

Summary

The latest reports seem only to confirm that clinical research at major academic institutions has gone way off track.  It now seems that in their haste to bring in external funding, university administrators and the academic researchers who are beholden to them have sadly neglected the protection of their own patients.  As we have said ad infinitum, true health care reform would turn leadership of health care organizations over the people who understand and are willing to uphold the mission of health care, and particularly willing to put patients' and the public's health, and the integrity of medical education and research when applicable, ahead of the leaders' personal interests and financial gain.

ADDENDUM (25 March, 2015) - See also numerous posts by Professor Elliott on the Fear and Loathing in Bioethics blog,  by Bill Gleason in the Periodic Table blog,  and by Mickey Nardo on the 1BoringOldMan blog. 

ADDENDUM (30 March, 2015) - Note that after receiving offline comments, I changed the first paragraph to emphasize the clarity is about the trial, rather than the patient's death, and second paragraph to clarify that the order to commit was stayed.

Princess Health andHealth reform law has been good for hospital finances, health-care costs, Obama administration says.Princessiccia

Princess Health andHealth reform law has been good for hospital finances, health-care costs, Obama administration says.Princessiccia

health care costs health insurance health reform hospitals managed care Medicaid obamacare Patient Protection and Affordable Care Act

Gusty 20:15 Add Comment

U.S. hospitals have saved billions of dollars because the federal health-reform law has provided coverage for patients who were once charity cases, the Obama administration announced Monday, the fifth anniversary of the Patient Protection and Affordable Care Act.

"Hospitals also saw fewer emergency room visits, which rack up far higher costs and often leave hospitals with the tab," Sarah Ferris writes for The Hill, which covers Congress. "The government�s report, which focuses on the benefits of Medicaid expansion, is an effort to entice states that have been politically resistant to expanding the program."

Kentucky hospitals have acknowledged that the law has reduced their losses from "uncompensated care," but say other aspects of the law have created a mixed effect, depending partly on hospitals' ability to adapt. The increase in coverage has brought hospitals much more money, but they say continued problems with managed-care Medicaid have cause them financial difficulty.

From paying patients' point of view, the law appears to have reduced inflation in health-care costs, but has not achieved advocates' goal of reducing costs. A White House report said, "Since the Affordable Care Act was enacted, health care prices have risen at the slowest rate in nearly 50 years. Thanks to exceptionally slow growth in per-person costs throughout our health care system, national health expenditures grew at the slowest rate on record from 2010 through 2013."

For the White House's Kentucky-specific list of benefits of the law, click here.

Princess Health andReform law 'quietly accomplishing the goals it was created to achieve,' McClatchy Newspapers reporter writes.Princessiccia

Princess Health andReform law 'quietly accomplishing the goals it was created to achieve,' McClatchy Newspapers reporter writes.Princessiccia

health care costs health insurance health reform obamacare Patient Protection and Affordable Care Act

Gusty 08:25 Add Comment

The federal health-reform law is still controversial and still facing a legal challenge, but "is quietly accomplishing the goals it was created to achieve," Washington correspondent Tony Pugh reported for McClatchy Newspapers on the occasion of the law's fifth anniversary. (The Lexington Herald-Leader is a McClatchy paper.)

"The nation�s uninsured rate has plummeted as more Americans enroll in Medicaid or in federal and state marketplace coverage," Pugh notes. "The law�s consumer protections and insurance-benefit requirements have improved the quality of coverage for millions of people who get health insurance outside the workplace. Premiums for marketplace health insurance have largely been reasonable and have increased only moderately thus far. Long-term cost estimates for providing coverage under the law have been falling."

Howver, Pugh writes, "The law may never overcome the bitter politics that surrounded its enactment and that partly define its legacy. Long viewed as a government overreach, the health-care law has been problematic for those who want the private insurance market to dictate who gets health insurance and what it should cost. . . . Moreover, the law�s requirement that most Americans have health insurance is seen as an infringement on individual freedom. The Supreme Court ruled in June 2012 that the so-called individual mandate didn�t violate the Constitution."

The White House issued a state-specific list of the law's benefits. For Kentucky's, click here.

Princess Health andObama says health-reform law working better than expected.Princessiccia

Princess Health andObama says health-reform law working better than expected.Princessiccia

health insurance health reform obamacare president

Gusty 21:01 Add Comment

President Obama made this statement on the fifth anniversary of the Patient Protection and Affordable Care Act:

On the five-year anniversary of the Affordable Care Act, one thing couldn�t be clearer:  This law is working, and in many ways, it�s working even better than anticipated.

After five years of the Affordable Care Act, more than 16 million uninsured Americans have gained the security of health insurance � an achievement that has cut the ranks of the uninsured by nearly one third.  These aren�t just numbers.  Because of this law, there are parents who can finally afford to take their kids to the doctor.  There are families who no longer risk losing their home or savings just because someone gets sick.  There are young people free to pursue their dreams and start their own business without worrying about losing access to healthcare.  There are Americans who, without this law, would not be alive today.

For Americans who already had insurance before this law was passed, the Affordable Care Act has meant new savings and new protections.  Today, tens of millions of Americans with pre-existing conditions are no longer at risk of being denied coverage.  Women no longer have to worry about being charged more just for being women.  Millions of young people have been able to stay on their parents� plan until they turn 26.  More than 9 million seniors and people with disabilities have saved an average of $1,600 per person on their prescription medicine, over $15 billion in all since the Affordable Care Act became law.  More than 70 million Americans have gained access to preventive care, including contraceptive services, with no additional out-of-pocket costs.  And the law has helped improve the quality of health care: it�s a major reason we saw 50,000 fewer preventable patient deaths in hospitals over the last three years of data. 

The cynics said this law would kill jobs and cripple our economy.  Despite the fact that our businesses have created nearly 12 million new jobs since this law was passed, some still insist it�s a threat.  But a growing body of evidence � actual facts � shows that the Affordable Care Act is good for our economy.  In stark contrast to predictions that this law would cause premiums to skyrocket, last year the growth in health care premium costs for businesses matched its lowest level on record.  If premiums had kept growing over the last four years at the rate they had in the last decade, the average family premium would be $1,800 higher than it is today.  That�s $1,800 that stays in your pocket or doesn�t come out of your paycheck.  And in part because health care prices have grown at their slowest rate in nearly 50 years since this law was passed, we�ve been able to cut our deficits by two-thirds.  Health care costs that have long been the biggest factor driving our projected long-term up deficits up are now the single biggest factor driving those deficits down. 

The Affordable Care Act has been the subject of more scrutiny, more rumor, more attempts to dismantle and undermine it than just about any law in recent history.  But five years later, it is succeeding � in fact, it�s working better than even many of its supporters expected.  It�s time to embrace reality.  Instead of trying yet again to repeal the Affordable Care Act and allowing special interests to write their own rules, we should work together to keep improving our healthcare system for everybody.  Instead of kicking millions off their insurance and doubling the number of uninsured Americans, as the House Republican budget would do, we should work together to make sure every American has a chance to get covered.

Five years ago, we declared that in America, quality, affordable health care is not a privilege, it is a right.  And I�ll never stop working to protect that right for those who already have it, and extend it to those who don�t, so that all of us can experience the blessings of life, liberty, and the pursuit of happiness in this country we love.  

Princess Health andAs tax deadline nears, most uninsured appear likely to choose penalty; some with coverage are having to refund part of subsidy.Princessiccia

Princess Health andAs tax deadline nears, most uninsured appear likely to choose penalty; some with coverage are having to refund part of subsidy.Princessiccia

health insurance health reform income insurance insurance coverage obamacare taxes

Gusty 09:16 Add Comment

Kentucky Health News

Most people facing a tax penalty for not having health insurance appear likely to pay it instead of taking advantage of a special opportunity to but coverage and minimize the penalty.

"Major tax-preparation firms say many customers are paying the penalty and not getting health insurance," reports Stephanie Armour of The Wall Street Journal. "Research also suggests that many people who lack health insurance will pay the penalty and not get covered this year."

Many polls have found that many if not most people without health insurance are unaware that they are subject to a tax penalty under the federal health-reform law. That percentage appears to be declining as they prepare their income-tax returns, but a poll taken in late February found that when told of the penalty, only 12 percent of the uninsured said they would get coverage.

For many people, the choice is simply financial, since coverage for them would be more expensive than the penalty -- 1 percent of their income, or $95 per adult or $47.50 per child, whichever is larger. Others say they don't need coverage, and some object to the penalty or the law altogether.

The penalty will increase to 2 percent of income and $325 per adult or $167.50 per child for the 2015 tax year, so if you are uninsured and don't qualify for Medicaid or one of the law's exemptions, the end of the special enrollment period, April 30, is the last chance to avoid that penalty.

"In late February, H & R Block reported that its uninsured clients had paid an average penalty of $172," reports Abby Goodnough of The New York Times. "The money comes out of refunds, while people who do not get refunds are required to pay the Internal Revenue Service by April 15."

Some people who have coverage "might find another unpleasant surprise: As many as half the nearly 7 million Americans who got subsidies to offset their premiums may have to refund money to the government, according to an estimate by H & R Block," the Journal reports. "The subsidies are based on consumers� own projections of their 2014 income, but some estimated incorrectly and received overly generous credits. Those people will see smaller-than-expected refunds or could owe the government money."

"H & R Block also found that as of Feb. 24, just over half of its clients with subsidized marketplace coverage had to repay a portion of their subsidy because their 2014 income turned out to be higher than what they estimated when they applied for coverage," the Times reports. "The process includes "new forms that even seasoned preparers are finding confusing."

The Obama administration announced last month that 800,000 people with insurance bought under the reform law had received incorrect information needed for their tax returns. About 10 percent of them have still not received corrected forms, it announced Friday. "The administration said people who have not received the corrected forms do not have to wait to file their taxes and will not have to pay any additional tax due to the effort," The Hill reports.

The Wall Street Journal reports, "Consumers who already filed their tax returns using the incorrect forms provided though state or federal exchanges won�t be required to file amended forms, and the Internal Revenue Service won�t assess additional taxes, said Mark Mazur, the Treasury Department�s assistant secretary for tax policy."