Showing posts with label hepatitis c. Show all posts
Showing posts with label hepatitis c. Show all posts

Sunday, 22 May 2016

Princess Health and Justice secretary, drug-policy chief and ex-health boss back needle exchanges but 'political rhetoric' can trump science. Princessiccia

By Melissa Patrick
Kentucky Health News

CORBIN, Ky. � Local officials and legislators continue to debate and sometimes reject needle exchanges, but two state officials and a former state health commissioner voiced their strong support of them at a pubic forum May 17 in Corbin.

Dr. William Hacker:
"Needle exchanges work."
"Needle exchanges work," said Dr. William Hacker, chair of Shaping Our Appalachian Region's Health and Wellness Advisory Committee and former state health commissioner. "We would, as a public health role, encourage them to be extended."

Hacker spoke at the "Cumberland River Forum on Opioid Use Disorders: A Time for Community Change," one of three public forums on the subject in Kentucky in May.

The General Assembly authorized needle exchanges in the 2015 anti-heroin bill, as a way to decrease the spread of HIV and hepatitis C, which are commonly spread by the sharing of needles among intravenous drug users. They require both local approval and funding.

Kentucky's rate of hepatitis C is the highest in the nation, and a recent federal Centers for Disease Control and Prevention report said that of the 200 counties in the nation that are most susceptible to a hepatitis C or HIV outbreak, 54 of them are in Kentucky.

So far, only 14 counties in Kentucky have either approved or are operating needle exchanges: Jefferson, Fayette, Jessamine, Franklin, Clark, Kenton, Grant, Harrison, Pendleton, Carter, Boyd, Elliott, Pike and Knox.

Justice Secretary John Tilley:
"Real facts and real science"
Justice Secretary John Tilley, who was instrumental in getting the heroin bill passed when he was a state representative from Hopkinsville, encouraged communities to look at the evidence-based research that supports needle-exchange programs and to not listen to the political rhetoric.

"We've got to push aside this political rhetoric on topics like this one and talk about real facts and real science," he said. "These programs have been validated by meta-analysis. ... Those who seek out a needle exchange are five times more likely to enter treatment. These programs continue to beat back blood-borne illnesses like hepatitis C and HIV, at rates we cannot duplicate without these programs. They are universally successful at what they do."

Tilley said after the meeting that addiction is a chronic disease and should be treated as a public-health crisis, noting that other diseases are treated based on science and medicine, not opinion.

"When you go to the doctor, you don't ask him his political view of a particular health program," he said. "Well, this is no different. And for me to substitute my judgment for the science is dangerous."

Van Ingram changed his mind
Van Ingram, executive director of the Governor's Office of Drug Control Policy, said his opinion about needle exchanges changed after he researched them and learned how effective they are at decreasing the spread of hepatitis C and HIV. He also noted that these programs provide testing and treatment referral for these infectious diseases, and also help participants get treatment.

"Eleven years ago I left law enforcement, and if you had told me that I would end up being the poster boy for syringe exchange, I would have said you were crazy," he said. "But quite honestly, they do work."

Ingram also noted the CDC study and reminded the audience of the "enormous" HIV outbreak that occurred last year in Scott County, Indiana, 30 miles north of Louisville.

"So if a syringe exchange can keep us from having a rapid HIV outbreak, I think that is probably a good trade-off," Ingram said.

But evidence-based research isn't always enough to convince policy makers that needle exchange programs don't condone or perpetuate drug use.

The Georgetown newspaper answered its
question in its story. The answer is yes.
Last week it was reported that two Kentucky counties decided against needle exchanges. Boone County's Fiscal Court silently said no to a needle exchange by refusing to call up a resolution to support one, Mark Hansel reported for NKyTribune. And the Scott County Fiscal Court voted 5-3 against one, Dan Adkins reported for the Georgetown News-Graphic. Adkins followed up with a featured front-page story about the county's heroin problem.

A point of contention among Republicans in the General Assembly is that some of the exchanges don't require a needle-for-needle exchange, which they say was their intent.

Then-Attorney General Jack Conway said Dec. 18 that needle exchanges did not have to be one-for-one. It is also widely accepted that not requiring one-for-one is considered a best practice across the country to prevent the spread of HIV and hepatitis C and to stop intravenous drug users from sharing and reusing needles, Dr. Sarah Moyer, the interim director of the Louisville Metro Department of Public Health and Wellness, told Kentucky Health News in March.

Last session, as the Senate voted to amend House Bill 160 to require one-to-one exchanges, Senate Republican Floor Leader Damon Thayer of Georgetown threatened to file a bill to eliminate them altogether next session if they don't make this change during the upcoming year.

In its original form, HB 160 was a bill to educate the public about how to safely dispose of hypodermic needles in order to keep them out of landfills. The House let the bill die without another vote.

Tilley said after the meeting, "Culture and change takes a while," and noted that while he respected his colleagues differing opinions, he said it is likely that this topic is not in their "wheelhouse."

"So, I think the more they learn the more they will come along," he said. "What we should do is all come back to the table and talk about how the programs that are now in place in Kentucky are working and how the reliance on science and evidence based policy makes them work."

Friday, 6 May 2016

Princess Health and  Three more Kentucky counties get needle exchanges; several others discussing, some debating; most are in early stages. Princessiccia

Princess Health and Three more Kentucky counties get needle exchanges; several others discussing, some debating; most are in early stages. Princessiccia

By Melissa Patrick
Kentucky Health News

Harrison, Pike and Knox counties are the latest in Kentucky to approve a needle-exchange program, bringing the total number of counties to 14, and several more are getting close.

Needle exchanges were authorized by the 2015 anti-heroin bill in an effort to decrease the spread of HIV and hepatitis C, which are commonly spread by the sharing of needles among intravenous drug users. They require both local approval and funding.

The other counties that have either approved or are operating needle exchanges are Jefferson, Fayette, Pendleton, Carter, Grant, Jessamine, Franklin, Clark, Boyd, Kenton and Elliott.

Campbell County close, could have domino effect

The Campbell County Fiscal Court voted 3-1 May 4 to approve a needle exchange and now awaits the support of the City of Newport, Mark Collier of Fort Thomas Matters reports for WCPO-TV, its news partner.

If approved, the exchange will be be operated by the Northern Kentucky Health Department and paid for by a grant from the R.C. Durr Foundation. It also has a a sunset provision that would make it expire Dec. 31, 2018.

Commissioner Charlie Coleman, the only dissenter, said he opposed the exchange because Campbell County residents told him "overwhelmingly" that they didn't want one, Collier reports. He was also not comfortable with the proposed location in the Fiscal Court building.

While Kenton County has approved a mobile needle exchange and the City of Covington has also approved one, both programs are contingent on Boone or Campbell counties to join the effort.

The Fort Mitchell City Council passed a resolution April 18 supporting a needle exchange, making it the second Kenton County city to do so. Independence passed a similar resolution earlier this year, Melissa Stewart reports for The Cincinnati Enquirer.

Some counties in very early stages

The Whitley County Board of Health has unanimously voted in support of a needle exchange program, Mark White reports for the Corbin-Whitley News Journal. The county health department and the Whitley County UNITE Coalition, which works toward reversing the country's opioid epidemic, have held a public meeting to discuss the topic.

Mercer County will hold a community forum May 16 from 6 to 8 p.m. at the county Extension office to discuss a needle exchange, Kendra Peek reports for The Advocate-Messenger in Danville. Their program has been prompted by reports of two people stuck by discarded needles in public places in the county. County Judge Executive Milward Dedman told Peek he was "leaning in favor of it."

Nelson County is also considering a needle exchange, Randy Patrick reports for The Kentucky Standard in Bardstown. The public-health director for the Lincoln Trail District Health Department, Sara Jo Best, gave a presentation in support of the program April 19 at the Nelson County Fiscal Court meeting.

The Laurel County Board of Health is considering a needle exchange and will further discuss it at its June 9 meeting, Kelly McKinney reports for The Sentinel-Echo.

Ben Carlson of The Anderson News recently told what now reads like a familiar story about the exchange that occurs in an early needle exchange educational meetings. The Anderson County Health Department held such a meeting April 25.

At the meeting, health officials shared research showing that needle exchanges decrease the rates of HIV and hepatitis C caused by shared needle use; do not increase drug use; help connect users with counseling and treatment; and get dirty needles off the street.

It also included complaints from opponents who say that needle exchanges are "tacit approval of IV drug abuse." The foes included peace officers.

�The sheriff and I have over six decades of law-enforcement experience combined, and we�ve used those to teach children about the dangers of drugs,� said Chief Deputy Sheriff Joe Milam. �We�re not going to say don�t use drugs, but if you do, use this. We are not in favor of this.�

Exchanges get use, award

Lexington's needle exchange program is adding on-site referrals to rehabilitation programs to its needle exchange, which has been operating since September, reports the Lexington Herald-Leader. Since its opening, the program has received 10,297 used needles and given out 10,803 clean ones.

The Little Sandy District Health Department, which runs needle exchanges in Olive Hill and Grayson, recently received the Kentucky Public Health Association Commissioner's Award for its needle exchange. Since Feb. 4, more than 500 dirty needles have been exchanged in both Carter County locations, Joe Lewis reports for the local weekly, the Journal-Times.

Thursday, 5 May 2016

Princess Health and Study says intravenous drug users in almost half of Kentucky's counties are at high risk of getting hepatitis C or HIV. Princessiccia

By Melissa Patrick
Kentucky Health News

A preliminary report by the federal Centers for Disease Control and Prevention has identified 220 counties in the United States as being most vulnerable to outbreaks of HIV and hepatitis C among those who inject drugs in those communities, and 54 of those counties are in Kentucky.

Most are in Appalachia, but the list includes the non-Appalachian counties of Hickman, Breckinridge, Grayson, Allen, Taylor, Boyle, Mercer, Carroll, Gallatin Grant and Campbell.
Counties deemed most vulnerable to outbreaks are green; top 25 of 220 in U.S. are numbered on map.
Kentucky leads the nation in the rate of acute hepatitis C, with 4.1 cases for every 100,000 residents, more than six times the national average, according to the CDC.

�Both HIV and hepatitis C can be transmitted when people who inject drugs share their needles," Doug Hogan, acting communications director for the Cabinet for Health and Family Services, said in an e-mail to Kentucky Health News. "Many of Kentucky�s HCV cases are among rural youth, ages 12-29, who have been sharing needles."

Clark County Health Director Scott Lockard called the CDC report a "wake-up call."

"We are potentially on the leading edge of one of the biggest public-health crises to hit our state," Lockard said in an e-mail to Kentucky Health News. "It will take a combined effort across sectors to prevent an HIV outbreak in the SOAR region such as the one that occurred in Scott County, Indiana," north of Louisville.

Lockard made these comments in April after attending a Shaping Our Appalachian Region roundtable that focused on substance abuse and intravenous drug use in the region. More than half (56 percent) of the 220 counties identified as most vulnerable for HIV or hepatitis C were located in the Appalachian regions of Kentucky, Tennessee and West Virginia.

"About 25 percent of our state�s population lives in these 54 counties," Hogan said.

The CDC began this study after an unprecedented outbreak of HIV infections occurred in Scott County, Indiana, in 2014 among its intravenous drug users to see what other counties might be vulnerable to such an outbreak.

Researchers looked at all 3,143 U.S. counties and based their rankings on six variables, including: the number of overdose deaths, per-capita-income data, unemployment data, population studies, prescription opioid sales, and prescription sales for opioid treatments such as buprenorphine.

The report points out that this does not mean that HIV or hepatitis C outbreaks are inevitable in these counties, or that there is a current problem with intravenous drug users in these counties, but says that intravenous drug users in these counties are at a higher risk.

One way to slow down the spread of HIV and hepatitis C is through needle exchanges, where intravenous drug users trade dirty needles for clean ones. Needle exchanges were authorized in Kentucky under a 2015 anti-heroin law but also require local approval.

So far, only Louisville and Lexington and the counties of Boyd, Carter, Clark, Elliott, Franklin, Grant, Harrison, Jessamine, Kenton, Knox, Pendleton and Pike are either operating or have approved such programs. Of the 54 high-risk counties, only Boyd, Carter, Clark, Knox and Pike counties have operating needle exchanges.

Hogan said, "The Kentucky Department for Public Health is working closely with (the) CDC and at-risk communities to increase HIV and hepatitis C testing, and is assisting counties in their processes of establishing syringe exchange programs."

Here's a list of Kentucky counties and their national rankings for vulnerability to the rapid spread of HIV and hepatitis C among people who inject drugs: Wolfe, 1st; Breathitt, 3rd; Perry, 4th; Clay, 5th; Bell, 6th; Leslie, 8th; Knox, 9th; Floyd, 10th: Clinton, 11th; Owsley, 12th; Whitley, 14th; Powell, 15th; Knott, 17th; Pike, 21st; Magoffin, 23rd; Estill, 25th; Lee, 30th; Menifee, 31st; Martin, 34th; Boyle, 35th; Lawrence, 39th; Rockcastle, 40th; Harlan, 45th; McCreary, 48th; Letcher, 50th; Johnson, 53rd; Russell, 54th; Elliott, 56th; Laurel, 65th; Carroll, 67th; Taylor, 75th; Grant, 77th; Adair, 93rd; Lincoln, 97th; Wayne, 99th; Cumberland, 101st; Gallatin, 108th; Bath, 125th; Grayson, 126th; Greenup, 129th; Green, 132d; Casey, 153d; Carter, 154th; Monroe, 163d; Garrard, 167th; Robertson, 175th; Lewis, 178th; Edmonson, 179th; Allen, 180th; Boyd, 187th; Hickman, 191st; Breckinridge, 202d; Campbell, 212th; and Mercer, 214th.

Thursday, 31 March 2016

Princess Health and  Kenton County's approval of a needle exchange inches Northern Kentucky, hit the hardest by heroin, toward getting one. Princessiccia

Princess Health and Kenton County's approval of a needle exchange inches Northern Kentucky, hit the hardest by heroin, toward getting one. Princessiccia

The Kenton County Fiscal Court unanimously approved a mobile needle exchange program March 29, which moves the City of Covington's needle exchange program one step closer to fruition, Terry DeMio reports for the Cincinnati Enquirer.

The Fiscal Court's approval was one of several conditions required by the City of Covington to allow its exchange to move forward. Covington's plan also requires two other counties in the Northern Kentucky Health District to adopt exchanges (only Grant County has); limits access to only resident's of the district's four counties; and would move the exchange to St. Elizabeth Healthcare hospital.

In addition, it requires a one-for-one needle exchange and a mandate that all participants must be tested for hepatitis C, hepatitis B, HIV, and, where applicable, pregnancy. This condition is likely not legal and is being investigated by the Northern Kentucky's Health Board's legal counsel, DeMio reports.

Kenton County's plan differs from Covington's in that it mandates only the offering of these tests, DeMio reports.

Both plans will require the Kenton County Board of Health's approval.

Needle-exchange programs were authorized by the state anti-heroin law passed in 2015, and require both local approval and funding. They are meant to slow the spread of HIV and hepatitis C, which are commonly spread by the sharing of needles among intravenous drug users. Northern Kentucky has been hit the hardest in the state by heroin and its hepatitis C rates have been reported at 19 times the national rate.

The needle exchange would be funded by $250,000 from the R.C. Durr Foundation, and the health department would use its staff and already available testing to further pay for the exchange, DeMio reports.

The Fiscal Court also approved exploring the idea of building a community-wide addiction treatment center on the county jail grounds; putting $25,000 toward a heroin helpline; and approved a resolution to encourage the Northern Kentucky Board of Health to create a high-quality prevention and education program for the community.

The Northern Kentucky Area Development District has already put out proposals for the heroin helpline, DeMio notes. And County Judge-Executive Kris Knochelmann told him that Boone and Campbell counties were willing to consider putting $25,000 each toward it, and that St. Elizabeth had promised $75,000 toward its operation.

The other needle exchanges in the state that are either operating or have been approved are in Louisville and Lexington and in the counties of Pendleton, Carter, Elliott, Franklin, Grant and Jessamine.

Wednesday, 1 July 2015

Princess Health and Bill Clinton, Paid to Speak to Biotech Conference, Extolled $1000 Pill to Prevent "Liver Rot," Despite Lack of Evidence that It Does. Princessiccia

Princess Health and Bill Clinton, Paid to Speak to Biotech Conference, Extolled $1000 Pill to Prevent "Liver Rot," Despite Lack of Evidence that It Does. Princessiccia

What were they thinking?

Former President Clinton Talkes to Pharma and Biotech Executives

In mid June, 2015, the Philadelphia Inquirer reported that former US President

Clinton was the keynote speaker at Klick Ideas Exchange, sponsored by Klick Health, a Toronto-based digital marketing agency, along with Veeva Systems and the Biotechnology Industry Organization. BIO, the Washington-based trade association, is holding its annual convention at the Pennsylvania Convention Center this week, attracting 15,000 people.

For his troubles he was apparently paid, however

his foundation did not respond to a request for information about Monday's speaking fee. Hillary Clinton's campaign also did not respond to a similar request. A spokeswoman for Klick Health declined to provide Clinton's fee.

It is likely he was well paid, since his going rate is very high:

disclosure forms indicated Bill Clinton received between $225,000 and $275,000 for each of eight speaches delivered between March 31 and May 14 of this year.

Clinton Endorses the Miraculous $1000 Pill

So what would a former president say to a bunch of pharmaceutical and biotechnology executives and their friends?  He chose to talk about the prices of new drugs:


Former president Bill Clinton said Monday in Philadelphia that high prices for some medicines are hard to justify, and the biotech and pharmaceutical industries should try full explanation and disclosure to make their case.

'Explain, explain, explain and disclose, disclose, disclose,' Clinton said in a speech and question-and-answer session before about 200 biotech and health-care executives at the National Museum of American Jewish History. 'Don't expect everybody to love you, but at least they will hear your side of the story.'

Who could quarrel with more explanations and disclosures?  President Clinton did not stop there, and went on to opine about prices versus drugs' purported value to patients, with a focus on new drugs for hepatitis C.

Clinton pointed to new hepatitis C drugs, Sovaldi and Harvoni, which are sold by Gilead Sciences for more than $80,000 for a 12-week program of treatment. Those medications often cure a disease that can cause liver disease and eventually lead to transplants or death, which are expensive, too. But the sticker price on the drug has caused a backlash by payers and patients.

'Who wants to let somebody's liver rot? Nobody,' Clinton said. 'Who's got $80,000 to spend? Not many. And if you're a small businessperson and you're in a small pool [of employer-based insurers], are you going to fire somebody who needs that treatment? These are all practical problems, and we can solve them.'

So the implications are clearly
-  President Clinton thinks it is reasonable to charge $80,000 for a course of treatment with Sovaldi, but society needs to figure out who will pay
-  Apparently he thinks it is reasonable because without treatment, patients with hepatitis C will get "liver rot," but the drugs will prevent that.

The Evidence Fails to Support the President

President Clinton's preparation for this talk apparently did not include speaking with someone who had critically reviewed the best evidence from clinical studies about hepatitis C, and the effects of new drugs on it, particularly, the effects of sofosbuvir (Sovaldi.)  Neither did President Clinton read Health Care Renewal.

If he did, he would have found out starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts herehere, and here.)

But because, as we noted here, concerns about the lack of evidence in support of Sovaldi and its new competitors have been anechoic, it might not have been so easy for President Clinton to quickly determine if hepatits C usually causes "liver rot," and whether Sovaldi almost always prevents "liver rot," and hence might just be worth $1000 a pill.

Hype Wins, Logic and Reason Lose

Unfortunately, the problem is not merely that the BIO folks hired a celebrity to tell them what they wanted to hear.  President Clinton has a lot more gravitas than a Hollywood star, even given his famous equivocation about the meaning of the word "is."

More unfortunately in this context, President Clinton is also the husband of the current front running Democratic candidate for President.  Should former Senator and Secretary of State Hilary Clinton win the election, would her health policy choices be influenced by the (probably erroneous) belief that the current extremely high prices of medical treatments, particularly new drugs, are reasonable because of their magical curative properties?  Furthermore, President Clinton is also the Founder and presumed current leader of the the Bill, Hilary and Chelsea Clinton Foundation whose goals include working "to improve global health and wellness,..."  Is this work based also based on the assumption that the astronomical prices of new drugs are justified by their miraculous powers?

Thus President Clinton's apparent endorsement of the wonderful powers of Sovaldi, despite the lack of good evidence underlying them, may carry a lot of weight.  

Conclusion

How distorted is health care these days.  Misinformation, even disinformation seems to dominate evidence and logic.  Concerns about health care dysfunction are suppressed by the anechoic effect.  Perhaps inspired by the generic managers who now run health care organizations, everyone seems to have become a health care expert, and so the reach of viewpoints on health care seems to be more about the celebrity of their proponents rather than their knowledge, or the logic and evidence underlying their views.

As a start, true health care reform has to somehow liberate good clinical evidence from where it has been hidden, and encourage logical discourse over marketing, public relations, hype, propaganda, and disinformation.

If only someone who knows something about health care, logic and evidence could get their views heard by ex Presidents and others who dominate our 24/7 conversation. 

ADDENDUM (2 July, 2015) - This post was republished on the Naked Capitalism blog

See also comments by Micky on the 1BoringOldMan blog.

References
1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Intern Med 2014. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.

Monday, 11 May 2015

Princess Health andKentucky led the nation in hepatitis C cases in 2013; state's rate rose 357 percent from 2007 to 2011.Princessiccia

Princess Health andKentucky led the nation in hepatitis C cases in 2013; state's rate rose 357 percent from 2007 to 2011.Princessiccia

By Tim Mandell
Kentucky Health News

Kentucky had the nation's highest rate of hepatitis C in 2013, with 5.1 cases per every 100,000 people, says a report by the federal Centers for Disease Control and Prevention. As many as 3.5 million people in the U.S. have hepatitis C and more than 56,000 Kentucky resident may have chronic hepatitis C infection, according to the state Cabinet for Health and Family Services. The main cause of hepatitis C is shared needles among intravenous drug users.

Hepatitis C cases rose 364 percent in Kentucky, Tennessee, Virginia and West Virginia from 2006 to 2012. The big increase was in 2007-11, when the rate rose 357 percent, a CDC state health profile says.

"Of the cases that have been reported and researchers gathered data about potential risk factors, 73.1 percent reported injecting drugs," Brian Wu reports for Science Times. Among new cases, 44.8 percent were people under 30.

While officials said HIV rates are low in the four Appalachian states, they said they fear that the increase in hepatitis C cases could lead to a rise in HIV cases, Wu writes. Officials said needle-exchange programs are key to reduce the number of potential HIV cases. Kentucky recently authorized such programs if local officials agree to them.

"About 4.5 million Americans older than 12 abused prescription painkillers in 2013 and 289,000 used heroin, according to the Substance Abuse and Mental Health Services Administration," Liz Szabo reports for USA Today. "About 75 percent of new heroin users previously abused opioid painkillers. The number of first-time heroin users grew from 90,000 people in 2006 to 156,000 in 2012, according to the CDC."

Kentucky has the third highest drug overdose mortality rate in the U.S., with 23.6 deaths per 100,000 people, says the 2013 report "Prescription Drug Abuse: Strategies to Stop the Epidemic," reports Trust for America's Health. "The number of drug overdose deaths�a majority of which are from prescription drugs�in Kentucky quadrupled since 1999 when the rate was 4.9 per 100,000."

Wednesday, 21 January 2015

Princess Health and Logical Fallacies in Defense of Aggresive Screening for and Treatment of Hepatitis C. Princessiccia

And the hepatitis C follies continue...

As we have frequently written, most recently last week, the hepatitis C screening and treatment bandwagon keeps rolling along.  There is constant public argument about the prices of treatment regimens, which approach $100,000 per patient in the US.  However, nearly all the public chatter, which seems mostly to come from corporate public relations people and marketers, investors and investment advisers, physicians with financial conflicts of interest, and pundits with little background in clinical epidemiology, seems never to question the assumption that the new drugs for hepatitis C are miraculous cures, which, of course, makes it hard to argue that they should not cost royal amounts.

The Lack of Good Evidence for the New Hepatitis C Treatments

However, starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts herehere, and here.)

Yet the lack of evidence, and the discussion up to last week of this lack of evidence, was mostly anechoic.  The public argument continued to be based on the assumption that new treatments of hepatitis C are miraculous.  

The BMJ Elicits An Interesting Response

Last week the British Medical Journal provided the first opportunity for a large audience to be exposed to skepticism about the hepatitis C bandwagon.  As we discussed here, the article by Koretz et al(3) based an affirmation of the four points above on a critical examination of the evidence. 

The article, and even our blog post about it, seem less anechoic than the previous articles and blog posts mentioned above.  At least a few commentators were inspired to a defense of the currently received wisdom.  However, in my humble opinion, the commentators mainly succeeded in demonstrating how received wisdom is often supported by illogic.

Defending the Received Wisdom with Logical Fallacies - Analysis of an Anonymous Comment 

Let me start with examples derived from dissecting the arguments of the first anonymous comments we received on our  blog post.

Examples of the Straw Man Fallacy

The commentators arguments included,

 The article suggests that the INF+RBV therapy is just as good as Harvoni,

Note that whether by "the article" the commentator meant the article by Koretz et al,(3) or the blog post on Health Care Renewal was not clear. In any case, neither made a statement to that effect.  Incidentally, I am not aware of any trial that directly compared Harvoni to some combination of interferon and ribavirin.

Both Koretz et al and I did refer to the ONLY trial in which one of the new antiviral drugs (sofosbuvir) was directly compared to peg-interferon and ribavirin.(4)    I discussed that trial in detail here ( http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html)  It showed no significant difference between the sustained viral responses at 12 weeks produced the two regimens.  As far as I can tell, there is NO evidence from any controlled trial that the new drugs are more effective than the old drugs.

So the commentator's argument was based on a misstatement of either Koretz and colleagues' or my argument.  In any case, it is therefore an example of a logical fallacy, the straw man fallacy.  The commentator was not arguing with something we wrote, but rather a straw man assertion which the commentator constructed.  

The commentator also said,

the claim that INF+RBV causes adverse effects in less than 1% of treated is just false,

Again, neither Koretz et al nor I wrote that.  So this began another argument based on the straw man logical fallacy. 

Koretz et al and I again referred to data from the Lawitz et al controlled trial.  That trial did suggest that the new drug produced more, not less severe adverse effects than the old drug.

The Red Herring Fallacy

The commentator wrote,

The statement that most patients will not go on to severe liver damage/liver cancer is unproven.

Presumably, this meant most patients with untreated hepatitis C will not go on to severe liver disease/ cancer.  This, however, is a statement about the natural history of a disease.  How a statement about disease prognosis could be "proven," however, is not clear.  It is not ethically easy, or perhaps possible, to do an experiment to prove the natural history of disease.  Our knowledge of prognosis therefore relies on observational studies.  While such studies can show association, they cannot prove causation.  So it is true that the prognosis of hepatitis C is unproven, but in practical terms it cannot be proven, or unproven.  While the commentator implied that longer term studies would show that patients have very bad outcomes, but no one knows that with certainty.  Thus, the assertion seems to be an example of a red herring, bringing up an irrelevant point to distract from the issue. 

Appeal to Authority

The commentator wrote,

SVR12 is a commonly accepted evidence for complete eradication of the virus

So the argument was that some people, perhaps, as was said at the conclusion of �Raiders of the Lost Ark,� top men believe that SVR means complete cure.



Why anyone believes that SVR12 means cure, and particularly whether this belief is based on evidence and logic was not explained. Just because some people, even top men, believe it does not mean it is true.  Thus this assertion is an example of another logical fallacy, an appeal to authority. By the way, there are plenty of people, including Koretz et al, who do not believe this. 

ADDENDUM (27 January, 2015) - I have now independently verified that the comments made on our blog by "anonymous" were made by a patient, and were made honestly, not cynically.  Furthermore, English is not the patient's first language, so he or she may have used English words such as "unproven" and "commonly accepted" somewhat differently than I understood. 

More Logical Fallacies in the BMJ Rapid Responses

Similarly, the article by Koretz et al has generated a few rapid responses which contain their own share of logical fallacies.  Some examples follow from comments through January 19, 2015.

Begging the Question and the Burden of Proof Fallacy

In the January 15, 2015 comments by Donna R Cryer

[The article by Koretz et al] severely undervalues the harms, to the individual and society, of active HCV infection. Reduction or avoidance of end stage liver disease or death are not the only appropriate measures of value of screening or the effectiveness of new medications.

Ms Cryer did not state what the values of the harms are, nor what the other appropriate measures might be, and provided no evidence for either assertion.  So this boils down to, "you are wrong and I am right."  More formally, this could be an example of begging the question, that is, an argument - in this case that screening is warranted - simply based on assumptions without explanation or supporting evidence.  On the other hand, this could also be an argument of the burden of proof fallacy.  Ms Cryer implies that Koretz et al must prove their conclusions, while she simply needs to assert hers. 

Appeal to Fear

Again from Cryer,

To propose that widespread birth cohort screening efforts be undermined is a disservice to every individual living, unknowingly, with the silently devastating disease that is hepatitis C.

Note that this sentence again appears to include begging the question, with the assertion that hepatitis C is "silently devastating," without explanation or supporting evidence, and the burden of proof fallacy, since it implicitly rejected Koretz and colleagues' argument that hepatitis C is not devastating to all patients, which was based on at least some evidence, without supplying any evidence that it is devastating.  Furthermore, this has an element of an appeal to fear in its use of the emotionally loaded word, "devastating."  Note that Koretz et al instead talked about specific complications of hepatitis C. 

Wishful Thinking

In the January 18, 2015, comments by Nowlan Selvapatt

newer regimes will ultimately improve pricing competition and sustained virologic response rates compared to interferon based therapies.

The author did not explain why these improvements will occur.  This could be another example of begging the question.  On the other hand, it also could be wishful thinking, which at least some people consider a logical fallacy as well as a cognitive bias.  Obviously, it would be nice for the newer treatments to achieve better results at lower prices in the future, but the future is not so predictable.

An even more explicit example of wishful thinking, alsoby Selvapatt, was,

The hope would be that ... [screening] would serve to reduce the economic and healthcare pressures associated with end stage liver disease caused by hepatitis C.

That would be the hope, certainly, but should the decision to screen be based on hope, or on evidence and logic.

Appeal to Authority

In the January 19, 2015, comments by Padmanabhan Badrinath

Regarding side effects Koretz et al state 'However, in a trial of sofosbuvir versus peginterferon plus ribavirin, 3% of participants taking sofosbuvir experienced serious adverse events compared with 1% in the peginterferon plus ribavirin arm (difference not significant)'. According to NICE 'Evidence Review Group (ERG) was satisfied that the evidence showed that treatment with sofosbuvir-based regimens was generally well tolerated and led to fewer adverse events than treatment with peginterferon alfa and ribavirin'.

Note that Koretz et al provided data, and again, that from the only clinical trial that compared a new drug (sofosbuvir) to an old drug, peg-interferon.  However, Badrinath contrasted that evidence with conclusions from the NICE report that were about apparently any, rather than just severe adverse events, and Badrinath did not provide any justification of or evidence supporting these conclusions.  While NICE is admittedly often considered to be pretty authoritative, simply stating its conclusions in the absence of evidence to refute Koretz's presentation of evidence amounts to an appeal to authority.

Summary

So it appears that the BMJ article on hepatitis C rendered the skepticism about the miraculous qualities of the innovative new antiviral drugs for hepatitis C less anechoic.  However, the response to these echoes seems to have been enriched with illogic.

So it goes in the brave new world of health care.  In the current money driven system, new "innovations" touted as miraculous constantly appear.  When a few skeptics question the evidence or logic supporting these claims, these doubts usually start as anechoic.  If the doubts are more widely expressed, the first line of defense seems to be often based on logical fallacies.  We most recently saw such fallacies deployed defending another drug, sacubitril, touted as miraculous from annoying skeptics.

Health care professionals, health care policy makers, and the public at large should not be swayed by illogic.   Our continuing series about how logical fallacies are used to support the status quo and the powers that be in health care suggests, if nothing else, that health care professional education ought to include courses in logic.

References

1.   Ollendorf DA, Tice JA et al.  The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection.  JAMA Inte Med 2014.  Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.
3. Koretz RL, Lin KW, Ioannidis JPA, Lenzer J.  Is widespread screening for hepatitis C justified? Br Med J 2015; 350: g7809. Link here.
4.  Lawitz E, Mangia A, Wyles D et al.  Sofosbuvir for previously untreated chronic hepatitis C infection.  N Engl J Med 2013; 368: 1878-1887.  Link here.

Thursday, 15 January 2015

Princess Health and The Fashion Challenges of the Emperor of Hepatitis C Treatment - Now in the BMJ, but Who Will Notice?. Princessiccia

Princess Health and The Fashion Challenges of the Emperor of Hepatitis C Treatment - Now in the BMJ, but Who Will Notice?. Princessiccia


As we wrote, most recently last week, the hepatitis C screening and treatment bandwagon keeps rolling along.  There is constant public argument about the prices of treatment regimens, which approach $100,000 per patient in the US.  However, nearly all the public chatter, which seems mostly to come from corporate public relations people and marketers, investors and investment advisers, physicians with financial conflicts of interest, and pundits with little background in clinical epidemiology, seems never to question the assumption that the new drugs for hepatitis C are miraculous cures, which, of course, makes it hard to argue that they should not cost royal amounts.

The Lack of Good Evidence for the New Hepatitis C Treatments

However, starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.


Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts herehere, and here.)

The British Medical Journal Publishes a Skeptical Review of Hepatitis C Screening  

Now an article in the British Medical Journal again raises questions about whether the emperor of hepatitis C treatment has some missing garments.(3)  To date, this article has received minimal attention from large media outlets.  I could only find stories in Bloomberg, and by the San Francisco Chronicle to date.

The article by Koretz et al focused on the evidence, or lack thereof in favor of screening for hepatitis C, but affirmed the following points

Most Patients with Hepatitis C Will Not Go On to Have Severe Complications of the Disease

To wit,

At least 2.7 million people are infected with hepatitis C virus in the US, and around 16?000 people each year die or have liver transplantations because of the disease. This suggests that less than 0.6% of infected patients will die of liver disease or be transplanted each year.

Also,

Retrospective studies of the natural course of hepatitis suggest that end stage liver disease is common and that it takes about 20 years to develop cirrhosis and 30 years to develop liver cancer. However, such series are usually composed of people who have a medical problem and are thus a sicker subpopulation of the people with chronic hepatitis C infection (referral bias). Furthermore, the total number of infected patients from which they are drawn is unknown.

Finally,

The risk of developing end stage liver disease is low for the first three decades of infection. Unfortunately, data on the risk beyond that point are limited. Only three studies provide data beyond 30 years, and the data are for children and women (both groups perhaps being at lower risk of progression) and for men in whom it was not clearly proved that the infections were chronic when diagnosed. Nonetheless, these data are consistent with previously cited epidemiological data from the general population, and it is likely that 80-85% of patients with chronic hepatitis C will die from non-hepatic causes

There is No Evidence from Randomized Controlled Trials that Treatment Prevents Most of these Complications

The most convincing way to establish efficacy of treatment is through well designed and conducted randomised, placebo controlled trials using clinical outcomes (morbidity and mortality). However, such trials are available only for interferon monotherapy. Ten randomised trials of interferon alfa have been conducted in patients with severe fibrosis or cirrhosis. The results were disappointing, even though at the time, expert opinion advocated interferon treatment for these patients.

There is No Clear Evidence that SVR Means Cure

Sustained virological response is not a cure. Viral RNA is sometimes found in body tissues even when the serum is clear; in some studies this has been found frequently. The virus also reappears in some patients with sustained response, and though this might be thought to be due to reinfection, at least sometimes these events represent the reappearance of the same virus. Moreover, a few patients with a sustained response develop end stage liver disease. In the largest observational study to assess this risk, 1001 patients with severe fibrosis (84% with cirrhosis) with sustained virological response were followed for up to eight years. During that time, 50 developed hepatocellular carcinomas, a 1% annual risk. Observational studies have suggested that the annual incidence of hepatocellular carcinoma in people with compensated cirrhosis secondary to hepatitis C infection is 1.4-3.3%.

There is No Evidence that the Benefits of Treatment Outweigh Its Harms

Claims of increased safety or tolerability of the newer treatment have been based on fewer and less severe side effects. However, the new drugs can still cause serious adverse events (resulting in persistent disability, hospital admission, or death).

Also,

Safety data are limited for the newest drugs. However, in a trial of sofosbuvir versus peginterferon plus ribavirin, 3% of participants taking sofosbuvir experienced serious adverse events compared with 1% in the peginterferon plus ribavirin arm (difference not significant). Combination therapy with sofosbuvir plus ledipasvir with or without ribavirin, was associated with a 0.5-2% rate of serious adverse events. According to a recent analysis of US Food and Drug Administration data, over one year telaprevir accounted for the single greatest number of reported severe and fatal skin reactions of any drug monitored. Unfortunately, we cannot weigh the risk versus the benefit at this time because we have no data on the precise benefit (if any).

Summary

Koretz et al supplied these conclusions:

If the treatment of hepatitis C is to be scaled up to cover a large portion of the 125-150 million infected people worldwide, regulatory agencies should ensure that drugs have been evaluated by long term follow-up of clinical outcomes (not just surrogate markers) in several thousands of patients. The financial cost of treatments have been discussed elsewhere, but given the uncertainty about the validity of the surrogate markers, the lack of evidence regarding clinical outcomes of treatment or of screening strategies, and the adverse events caused by the newer regimens, screening may be premature. 

By the same logic, it is not clear that treatment of asymptomatic patients found to have hepatitis C provides benefits that outweigh its harms.

Thus, more authoritative voices are saying that the hepatitis C treatment emperor is seriously fashion challenged.

If there is no good evidence that these drugs do more good than harm for asymptomatic patients, why should physicians prescribe them for these patients?  If use of these drugs in general has not been shown to do more good than harm, why should they be prescribed for any but the most desperate patients?  Finally, if these drugs have not been shown to do more good than harm, and the lack of evidence is clearly the responsibility of  the drugs' manufacturers who chose not to do very large and/or long-term randomized controlled trials and not to assess clinical outcomes, what justification is there for the gargantuan prices of these drugs?

A larger societal question is why the public discussion has been so dominated by enthusiasts for these drugs, and so little informed by the existing evidence, or lack thereof, from clinical research?  

To repeat,.. the Sovaldi (and now Harvoni, Viekira Pak, etc) case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence.  That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house.  And all the money we spend will likely not buy us the promised miracles and triumphs.

It is disappointing that so many physicians and other health professionals have been caught up in this hype and spin, probably abetted by their wishful thinking about cures of hepatitis C, and perhaps also abetted by financial conflicts of interest.  Yet to protect the best interests of their patients, they should be rigorously skeptical of illogical or evidence-free arguments made to further vested financial interests.

As we have said until blue in the face, true health care reform would bring some skeptical thinking and regard for evidence and logic into the health policy discussion.

ADDENDUM (19 January, 2015) - See also comments in the HealthNewsReview.org blog.

ADDENDUM (22 January, 2015) - See an analysis of logical fallacies found in comments arguing with this post, and employed by authors of rapid responses to the Kortetz et al article in the BMJ, in this post.

ADDENDUM (28 January, 2015) - This post was republished in OpenHealth News here

References
1.   Ollendorf DA, Tice JA et al.  The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection.  JAMA Inte Med 2014.  Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.
3. Koretz RL, Lin KW, Ioannidis JPA, Lenzer J.  Is widespread screening for hepatitis C justified? Br Med J 2015; 350: g7809. Link here.