March 20, 2015

Honorable Senator Jon Tester, DC Office
Honorable Senator Steve Daines, DC Office
Honorable Representative Ryan Zinke, DC Office
Honorable Governor Steve Bullock, Helena Capitol

Montana Board of Medical Examiners
301 South Park
Helena, MT 59602

Dear Honorable Senators Jon Tester, Steve Daines and Rep. Ryan Zinke, Honorable Governor Bullock; Respected Montana Board Members,
We are writing this letter on behalf of Dr. Mark Ibsen of Helena and patients suffering various acute and chronic pain conditions throughout Montana. We believe regulators are targeting the wrong physician (Ibsen). We want to bring you the harmed patient perspective as the model for treating chronic and intractable pain is FAILING THE CONSUMER and we desperately need your help.
We fear that you may not be aware of what is happening on the front lines. Unfortunately, the Montana State Medical Board is indirectly forcing consumers into the hands of interventional pain management, which we believe is a significant factor behind patient harm and need for opioid consumption. We will try to explain why.
First, back pain is a leading cause of disability and epidural steroid injections (ESIs) are pushed on back pain patients ESPECIALLY IN MONTANA. There is NO steroid approved by the FDA for epidural use and the most commonly used drug, Pfizer’s Depo-medrol, is now banned for epidural use in Australia and New Zealand: http://www.medsafe.govt.nz/profs/datasheet/d/Depomedrolinj.pdf
Kenalog, another commonly used drug, has a “Not For” (epidural use) on the datasheet.
There are 100 million Americans who suffer chronic pain, which meets the definition of a pandemic. Approximately 9 million injections are given annually in the U.S. (FDA Hearing, Nov. 24, 2014). At best, epidural steroid injections provide temporary relief. At worst, they cause a lifetime of pain and suffering and need for opioid therapy. Arachnoiditis is clearly listed on drug datasheets as a potential complication. Imagine what this costs insurance companies and federal /state disability retirement funds for temporary benefit (on the front end) plus permanent disabilities (on the back end).
We testified on the dangers of corticosteroids used to treat back pain at FDA headquarters in Silver Spring MD on Nov. 24, 2014. The Missoulian and Ravalli Republic reported our stories:
http://missoulian.com/lifestyles/hometowns/ravalli-county-residents-take-epidural-warning-to-fda/article_b45c9d85-c265-5f16-a6b2-31adeb21f053.html
The true risk of exposure is not thoroughly explained to patients. Terri presented a brief overview of risk, but it was difficult to present a comprehensive risk assessment at the FDA hearing as speakers were limited to 5 minutes: http://www.arachnoiditiscanada.com/fda-hearing-november-24.html
Rates of dural puncture vary depending on technique, experience, prior surgery, etc.
Gary testified about the abuse that he sustained as physicians in Missoula did not diagnose his intractable pain condition, arachnoiditis, caused by misplaced steroids in his spine. After he was harmed, his physician wanted to send him for MORE epidural steroid injections! Prior to medical injury, he was in excellent health and rarely took an aspirin for pain. Now he suffers intractable pain and cannot achieve adequate pain control in Montana because of the current attitudes towards prescribing.
Recent actions of federal agencies (DEA and FDA) are resulting in a shortage of opioids for legitimate pain patients; patients are denied access to pain control then coerced to undergo dangerous spinal procedures. Spinal surgeons in Missoula are pushing injections as a pre-requisite for spinal surgery. Epstein MD observed alarming rates of punctate CSF fistulas during lumbar surgery for stenosis/instability (18.2%) in her recent commentary on unnecessary ESIs (Surg Neurol Int. 2014).
Many other complications were discussed at the FDA hearing, including interarterial injection, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious complications are not being tracked: http://www.propublica.org/article/were-still-not-tracking-patient-harm
Second, patients are not informed about the true risk of many complications, and bodies are piling up in social media forums. One Arachnoiditis support group is now approaching 1000 members. Patients are typically given the run-around and labeled as drug addicts after they are harmed by physicians. Most arachnoiditis sufferers have to leave the State of Montana in order to achieve an accurate diagnosis. We are aware of other undiagnosed cases in Montana. Thanks to social media forums, patients are now training themselves to read their own MRIs (swollen or clumped nerve roots and scar tissue in the spinal cord on MRI axial images).
To add insult to injury, patients are misdiagnosed with Failed Back Surgery “Syndrome”, Post-Laminectomy “Syndrome”, and Fibromyalgia (to name a few) when in fact they suffer arachnoiditis.
We would be willing to assist with an educational awareness campaign as there is a serious problem with misdiagnosing in Montana. The most insidious problem associated with adhesive arachnoiditis is obstruction and alteration of cerebrospinal fluid flow because of SCAR TISSUE in the intrathecal space and the resulting “centralization” of pain, which most interventional pain doctors do not understand. It is critical that physicians learn how to differentiate central pain from peripheral extremity pain.
Dr. Forest Tennant provides guidance as uncontrolled pain can lead to serious health problems including cardiac arrest and stroke: http://www.thblack.com/links/RSD/Tennant-PainSigns-6p.pdf
Third, suicide is a problem for untreated chronic pain patients in Montana. Arachnoiditis survivors suffer suicide-level pain, and many take their lives to escape it. Our fellow arachnoiditis sufferer committed suicide after he could no longer endure the pain, following a brutal medical “assault” during which his pain physician injected several simultaneous steroid injections. His sister testified at the FDA hearing about the loss of her brother, and his tortuous life following the injections up until his death.
We lost yet another arachnoiditis friend to suicide as he suffered intractable pain, bowel and sexual dysfunction: http://www.thenationaltriallawyers.org/2014/03/2-88m-med-mal-man-suicide-pain/
We watch in horror as patients are coerced to undergo epidural steroid injections (over prescribing) because regulatory agencies are not addressing the underlying problems — driven by profit motives to do procedures, combined with the war on opioids. Unfortunately, the Montana Board’s attitudes towards opioids are now (indirectly) resulting in more patient harm. Patients are left with interventional pain practices, primarily ESIs and spinal implants. Patients are also coerced to undergo invasive “diagnostic” steroid injections prior to spinal surgery.
We suggest you take the time to watch videos produced by harmed patients as many rely on
high powered opiates to function. Their stories are all too familiar to us — denial of harm — then difficulty achieving an honest diagnosis:
https://www.youtube.com/watch?v=Of06usrj-tA
http://artforarachnoiditis.org/category/creative-non-fiction/survivors-stories/
http://www.cklaurence.com/epidurals.html
Some physicians in Missoula deny that Arachnoiditis even exists. We find this ironic now that the federal government (FDA) and Pfizer acknowledge it. It is grossly misdiagnosed in Montana. Patients who suffer are subjected to more abuse and denial of appropriate medications to treat pain. Clinical descriptions and case reports were presented in Practical Pain Management and Neurology Now:
http://www.practicalpainmanagement.com/pain/spine/arachnoiditis-part-1-clinical-description
http://www.practicalpainmanagement.com/pain/spine/arachnoiditis-part-2-case-reports
http://journals.lww.com/neurologynow/Fulltext/2014/10050/Agony_and_Arachnoiditis__Named_after_its.12.aspx
Montana is ground zero on this national debate. Many pain patients are misdiagnosed then accused of being addicts. The shortage of opioids – and the targeting of physicians who prescribe – is resulting in a national and state health care crisis, and Montana is in the midst of this national debate. Addicts will always find an available drug, but legitimate pain patients are thrown under the bus and left to suffer:
http://nationalpainreport.com/montana-becomes-ground-zero-in-the-opioid-debate-8825459.html
http://nationalpainreport.com/a-new-approach-to-prescribing-narcotics-8825780.html
Our request to the Montana Board of Medical Examiners
First, we ask that you dismiss any negative action(s) against Dr. Mark Ibsen because he is not the source of the problem in Montana. We think you need to be aware that Dr. Ibsen is not our physician, but it is a small world now, thanks to social media. Chronic pain patients are all in this together.
Second, we ask the Montana Board of Medical Examiners to investigate the alarming trend to coerce pain patients to undergo invasive procedures before physicians will prescribe medications. Interventional pain physicians are harming patients then abandoning them when they do not submit to more profitable invasive spinal procedures. We previously brought this to the attention of the Board as it is a serious public health issue.
Physicians must provide true informed consent to their patients. This includes sharing details regarding the April 2013 FDA warning: http://www.fda.gov/Drugs/DrugSafety/ucm394280.htm . It is also important that patients understand that all steroids are being used “off-label” when administered by the epidural route. After all, we have all been warned about the addictive nature of opioids.
It is critical that patients understand the potential risk of arachnoiditis (listed on Depo-medrol and Kenalog datasheets) before they submit to an ESI. If the Board had taken this action years ago, things would have turned out differently for us. Arachnoiditis is the suicide disease that often results in patients considering their exit as they lose everything to hellish pain; especially in the current climate as many no longer have access to appropriate doses of opioids necessary to control pain.
We are grateful to Dr. Ibsen for bringing this problem (access to pain control) from out behind the White Wall of Silence. We fear that if you sanction Dr. Ibsen, then more pain patients will either be abandoned or forced into harmful procedures. We have a front line perspective and hope you will listen to Montana patients as you address the source of the Big Pain problems in the Big Sky country.

Sincerely,
/s/ Terri Anderson
Terri Anderson
Injured Worker and Patient Advocate
Arachnoiditis Society for Awareness and Prevention A.S.A.P.
Hamilton, Montana

/s/Gary Snook
Gary Snook
Arachnoiditis Survivor and Patient Advocate
Arachnoiditis Society for Awareness and Prevention A.S.A.P.
Lolo, Montana

/s/ Terry Conyers
Terry Conyers
Arachnoiditis Survivor (Undiagnosed)
Hamilton, Montana

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Indiana has been using NPLEx for several years… and AG Zoeller implemented a website www.Bitterpill.IN.gov in Aug 2013.  Which is going to educate people on  how bad abusing drugs are… Apparently… not working all that well ?

Indiana Crowned Meth Capital of United States

http://www.tristatehomepage.com/story/d/story/indiana-crowned-meth-capital-of-united-states/31429/AU9QTgZ3UU6-SYJSwmx3-A

 Law enforcement has a mixed reaction to the numbers because Indiana seized more meth labs than any other state. Which means meth suppression tactics are working, but it could also mean the amount of meth labs are growing.
 
Here are the top five states for meth lab busts in 2013. Illinois with 673, Ohio with 1,010, Missouri, which held the crown last year, with 1,496, Tennessee with 1,616, and Indiana with the most meth lab busts in 2013 at 1,808.
   
Indiana State Police says the meth problem is growing across the state. “Last year was the first year that we had a meth lab seized in every county except one,” said Sgt. Niki Crawford with ISP Meth Suppression. The jewel in the meth crown, the county with the most meth lab busts is Vanderburgh County with 115 last year. “What that shows is the law enforcement efforts in Indiana particularly in Vanderburgh County and Evansville is ramped up. We’ve identified this is a problem in our community for over a decade now and as the years have gone by we have done more and more to address that problem,” said Sgt. Jason Cullum of the Evansville Police Department.

Law enforcement officers say there are several ways to counter the meth problem and it will take all hand on deck to overcome the widespread addiction. “It’s not always taking people the jail. That’s the easy part. The difficult part is getting buy-in from the community,” Sgt. Crawford.
In recent years state legislation has passed bills curbing the amount of the meth making drug pseudoephedrine can be purchased. Law enforcement is asking for tighter restrictions, but ultimately it’s up to the voters. “If the citizens aren’t communicating to their legislators what they want for their communities then the legislators don’t know what their constituents want,” said Sgt. Crawford. In the 2014 Indiana General Assembly several bills were introduced to further restrict the sale of pseudoephedrine, however none of them made it to the Governor Pence’s desk.

If you find a meth lab call 911 immediately. This enables an immediate response to a very dangerous situation. If you want to report suspicious activity in reference to methamphetamine production please call the Evansville Police Department Methamphetamine Suppression Unit at 812-436-7918

Here is a link to the ISP Meth Suppression page http://www.in.gov/meth/

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14-year-old accused of 3 CVS robberies on NW side

http://www.theindychannel.com/news/local-news/14-year-old-accused-of-3-cvs-robberies-on-nw-side

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Survey Finds Two-Thirds of Patients Unable to Get Hydrocodone

http://www.painnewsnetwork.org/stories/2015/3/19/survey-finds-two-thirds-of-patients-unable-to-get-hydrocodone

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An Orlando woman said Walgreens mistakenly gave her the wrong pills.  

Evelyn Singleton said she’s been taking the same blood pressure medication for years. So when she noticed her pills were a different size, she assumed she was just given the generic brand.

“I probably would’ve died; would’ve had a stroke or a heart attack,” said Singleton. “That’s my life. It’s my life.”

It turns out she was given the same medication at 10 times her normal dose.

The incident happened at the Walgreens on the corner of Hiawassee Road and old Winter Garden Road in Orlando.             

Singleton has since transferred her prescriptions elsewhere. Her attorney says if the pharmacy doesn’t make things right, they will go to court.

The pills were the same color and had the same markings.

“I noticed a difference, but I thought it was generic when I was taking it,” said Singleton.

She said taking one nearly killed her.

“I made it as far as the bed and I fell across the bed,” said Singleton.

Despite the label on the bottle showing the pills contained 10 milligrams of medication, Evelyn Singleton’s husband, Wade Singleton, called the pharmacy technician at the Walgreens and found out his wife had been given the 100 milligram dosage by mistake.

“At first, I said, ‘Are you serious?’ ;She said, ‘Yes sir. The 10 milligram and the 100 milligram are on the same shelf right next to each other,'” said Wade Singleton.

It was the second time in a month WFTV found out that a Walgreens had been accused of mixing up prescriptions.

Another woman said that instead of allergy medication, she was given a drug used by diabetics to lower blood sugar.

The two women now have major medical bills, and that is something the families hope to have paid by Walgreens and for Walgreens to give more training to its employees.

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Matthew Lowry, FBI Agent, Stole Heroin to Get High, Prosecutors Say

http://www.nbcnews.com/news/us-news/fbi-agent-stole-heroin-get-high-prosecutors-say-n327306

Matthew Lowry, FBI Agent, Stole Heroin to Get High, Prosecutors Say

A Washington, D.C., FBI agent was charged Friday with stealing heroin obtained in undercover investigations and using it to get high.

Matthew Lowry, 33, took bags of heroin out of his agency’s evidence storage facility, ingested some of it, then tried to cover it up by adding cutting agents and forging labels, the U.S. Attorney’s Office in Philadelphia said.

He was charged with 64 criminal counts — including obstruction of justice, falsification of records, conversion of property and possession of heroin.

Lowry was a member of his office’s Cross-Border Task Force, which conducts large-scale drug investigations. His crimes occurred in 2013 and 2014, when on several occasions he signed out bags of heroin from the evidence facility under false pretenses and kept them in his car, prosecutors said.

Lowry would then dip into the bags and replace the missing amount with the nutrition supplement Creatine or the laxative Purelax before putting remaining drugs into new bags with old or forged labels, prosecutors said.

On some occasions, Lowry also took heroin obtained during undercover purchases, and kept the drugs in his car, periodically ingesting it before logging them into the evidence facility weeks or months later, prosecutors said. Once, he allegedly kept the bag and never turned it in.

The investigation has not identified any criminal conduct by other agents, prosecutors said.

If convicted of the charges, Lowry faces at least 87 months in prison.

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Patients Will Record Encounters, and Docs Must Adjust

http://www.medpagetoday.com/PublicHealthPolicy/Ethics/50564?xid=nl_mpt_DHE_2015-03-20&utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=ST&eun=g578717d0r&

Physicians must accept the possibility that every conversation with a patient may be secretly recorded by the patient, wrote two physicians and a lawyer in the Journal of the American Medical Association.

That is the first step for physicians to protect themselves from possible negative consequences of such encounters, said Michelle Rodriguez, JD, who is also a medical student, and colleagues at the University of Texas Health Science Center in San Antonio, in a Viewpoint.

Federal law allows the recording of a private conversation as long as at least one party to the conversation consents to the recording. Some states, such as California and Massachusetts, require the consent of all parties to record.

Trying to change the law would be a long, expensive, and not necessarily fruitful process, wrote authors.

Instead, they urged physicians to “embrace” the situation, arguing that they should use it as an opportunity to refine their communication skills and strengthen the patient-doctor bond.

If a doctor suspects that a conversation is being recorded, he or she should ask the patient. “Then, regardless of the answer, the physician can express assent, note constructive uses of such recordings, and educate the patient about the privacy rights of other patients so as to avoid any violations,” authors wrote.

Rodriguez and colleagues acknowledged that recording without asking physicians first may change the nature of the patient-physician relationship. For example, doctors may feel vulnerable or mistrustful with current or future patients.

Personal accounts by physicians reflect these feelings. “I feel violated,” wrote one pseudonymous blogger. “It angers me, and I automatically lose trust in that patient and their family.”

Some posters on a popular online forum for physicians agreed. “Personally I really dislike this and it makes me awkward/uncomfortable,” wrote one poster.

“I had a report one day that one of my patients was recording me with a tape recorder in his pocket. When I confronted him, he would not confirm or deny it. ‘So what if I was?’ he asked. I sent him a discharge letter because he was so smug and asinine about it,” said another poster.

But ultimately, Rodriguez and colleagues argued, the motives of patients and families are irrelevant. Physicians must continue to establish good relationships with their patients, be compassionate, and act professionally regardless.

This is not the first time physicians have suggested their peers use the rising tide of recording to their advantage.

The fear of recording for use in litigation is a legitimate one, Deep Ramachandran, MD, a pulmonary and critical care physician in Michigan, wrote in a post on KevinMD.

But he encouraged doctors not to assume the worst about patients who record conversations. The practice may be beneficial for recall of information by patients or family members.

At the same time, he encouraged patients to ask before hitting record. “So to my patients who feel the need to secretly make recordings of our conversation, please feel free the ask the question, ‘May I record this conversation?’ You’ll find the answer is often ‘Yes, please do!'” Ramachandran wrote.

Roger Kirby, MD, a urologist and director of The Prostate Centre in London, wrote that physicians have an obligation to treat patients even if they discover covert recording. “… you may be upset by the intrusion, but if you act in a professional manner at all times, then it should not really pose a problem,” he wrote in post in BJU International.

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Pot for pets? Nevada bill would make medical marijuana available for sick animals

http://www.nydailynews.com/life-style/health/medical-marijuana-sick-pets-nevada-article-1.2153468

Give a dog a bowl.

Pets might soon be able to use pot under a bill introduced Tuesday in the Nevada Legislature.

Democratic Sen. Tick Segerblom is sponsoring the measure that would allow animal owners to get marijuana for their pet if a veterinarian certifies the animal has an illness that might be alleviated by the drug.

Segerblom said he’s concerned that some animals might have adverse reactions, but “you don’t know until you try,” he said.

Some veterinarians who have given cannabis to sick and dying pets say it has relieved their symptoms, although the substance hasn’t been proven as a painkiller for animals.

Damian Dovarganes/AP

A bill introduced in the Nevada Legislature Tuesday would allow animal owners to get marijuana for their pet with a vet’s permission.

Los Angeles veterinarian Doug Kramer told The Associated Press in 2013 that pot helped ease his Siberian husky’s pain during her final weeks, after she had surgery to remove tumors. Kramer said cannabis helped his dog, Nikita, gain weight and live an extra six weeks before she was euthanized.

“I grew tired of euthanizing pets when I wasn’t doing everything I could to make their lives better,” Kramer told the AP. “I felt like I was letting them down.”

The proposal is in its earliest stages and faces several legislative hurdles before it could become law. The pot-for-pets provision of SB372 is part of a larger bill that would overhaul the state’s medical marijuana law, removing penalties for drivers who have marijuana in their blood and requiring training for pot-shop owners.

Segerblom said he added the provision after being approached by a constituent.

Sen. Mark Manendo, a fellow Democrat and animal rights advocate, said he hadn’t heard of the practice of giving marijuana to animals and is concerned about its safety.

“That gives me pause,” he said. “Alcohol is bad, chocolate is bad for dogs.”

His own dog died in his arms at age 15, and the experience was difficult and emotional, he said.

But “I don’t know if I would’ve given him marijuana,” Manendo said.

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Congress Pressures FDA to Finalize Opioid Guidance

Threatens to shift $20 million from agency if abuse-deterrent guidance isn’t settled by June

http://www.medpagetoday.com/Psychiatry/Addictions/50541?xid=nl_mpt_DHE_2015-03-19&utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=ST&eun=g578717d0r&

The FDA will publish its long-awaited guidance on abuse-deterrent opioids by the end of June, in order to avoid a $20 million cut in funds to the commissioner’s office threatened by Congress.

An amendment by Hal Rogers (R-Ky.) to the “Cromnibus” appropriations bill passed last December requires that the guidance be finalized by June 30, otherwise $20 million will be moved from the salaries and expenses section of the FDA Commissioner’s office to its criminal investigations department to combat drug diversion.

Rogers is chair of the House Appropriations Committee.

“It’s a lot of money and the FDA is going to respond to that,” said Dan Mendelson, CEO of Avalere Health, a firm that tracks healthcare policy. “You always try to get rid of language like that because it does tie your hands.”

Indeed, an FDA spokesperson told MedPage Today that the organization “is aware of the provision and we are working to finalize the guidance before the June 30, 2015 deadline.”

Guidance for developing abuse-deterrent opioids has been a long time coming. It was initially released in January 2013, but the agency didn’t hold a workshop on the draft document a 2-day meeting last October.

While it’s unclear what the final language will be, the agency noted last fall that it plans to continue to evaluate approvals on a case-by-case basis — citing the fact that the science of abuse-deterrence is still unsettled.

In the meantime, four opioids have been approved with abuse-deterrent labeling: Targiniq, Hysingla, and reformulated Oxycontin from Purdue Pharma, and abuse-deterrent Embeda from Pfizer.

A reformulated version of Zohydro was approved but does not have abuse-deterrent labeling.

Zohydro, which is pure hydrocodone, was initially approved without any abuse-deterrence mechanism, setting off a firestorm of controversy.

Approvals of generic abuse-deterrent opioids have also been inconsistent; while FDA removed generics of OxyContin from the market once Purdue created an abuse-deterrent formulation, it did not do the same for Opana generics. The FDA did not give Endo Pharmaceuticals a label indication for abuse-deterrence for Opana.

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The DEA Is Seizing Cash Without Warrants In Its Version Of Stop-and-Frisk

http://www.forbes.com/sites/instituteforjustice/2015/03/19/the-dea-is-seizing-cash-without-warrants-in-its-version-of-stop-and-frisk/

Federal drug agents may be racially profiling and unjustly seizing cash from travelers in the nation’s airports, bus stations and train stations. A new report released by the Office of the Inspector General for the U.S. Department of Justice examined the Drug Enforcement Administration (DEA)’s controversial use of “cold consent.”

In a cold consent encounter, a person is stopped if an agent thinks that person’s behavior fits a drug courier profile. Or an agent can stop a person cold “based on no particular behavior,” according to the Inspector General report. The agent then asks people they have stopped for consent to question them and sometimes to search their possessions as well. By gaining consent, law enforcement officers can bypass the need for a warrant.

But after reviewing the DEA’s policies, the Inspector General concluded, “cold consent encounters and searches can raise civil rights concerns.” In one incident, DEA agents cold-stopped an African-American woman at an airport and allegedly subjected her to “aggressive and humiliating questioning”; the woman was a Pentagon lawyer and travelling on government business.

Little wonder research by the U.S. Department of Justice found that cold consent encounters are “more often associated with racial profiling than contacts based on previously acquired information.” Cold consent has even been compared to stop-and-frisk.

Moreover, agents can seize cash they find during a cold consent encounter. According to data analysis conducted by the Institute for Justice, half of all DEA cash seizures from 2009 to 2013 were under $10,000. Thanks to civil forfeiture laws, law enforcement can take cash and other valuable property, based on an officer’s often subjective determination of probable cause, even from those who have not been charged with a crime.

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