Tag Archives: drugs

Ultram ER

Ultram ER (tramadol HCl) is the first extended release tramadol product approved in the United States for relief of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Ultram ER is available in once-daily dosage strengths of 100 mg, 200 mg and 300 mg tablets.

The U. S. Food and Drug Administration (FDA) approved Ultram ER in September 2005 based on clinical and safety data obtained from four well- controlled clinical trials. More than 3,000 patients have been treated with Ultram ER in clinical trials.

Tramadol is a non-scheduled centrally-acting synthetic opioid analgesic that has been used in the treatment of moderate to moderately severe pain since its introduction in the United States in 1995. Ultram ER uses Biovail’s innovative Smartcoat(TM) technology* to produce an extended-release tablet that provides appropriate patients effective pain control over a 24-hour period in a convenient once-daily form of tramadol. In contrast, patients may need to take immediate release tramadol tablets every 4-6 hours for pain relief.

Ultram ER is contraindicated in any situation where opioids are contraindicated, including in those patients with a history of anaphylactoid reactions to opioids.

Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range and in patients taking certain medications such as tricyclic antidepressants, selective serotonin reuptake inhibitors or opioids. Administration of tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, other drugs that reduce the seizure threshold, or in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).

Tramadol, like other opioids used in analgesia, can be abused. Ultram ER should not be used in patients who are suicidal or addiction-prone, or taken with alcohol-containing beverages.

In clinical trials the most frequently reported side effects associated with Ultram ER were dizziness, nausea, constipation, somnolence, and flushing.

Ultram ER Extended-Release Tablets are intended for oral use only and should be swallowed whole. The tablets should not be chewed, crushed, or split.

Ultram ER should not be administered at a dose exceeding 300 mg per day.

On the Net

Ultram description on medicinenet.com
Ultram description on opioids.com

Agreement form recommended for use before opioid treatment is prescribed

I understand that Dr ____________ is prescribing opioid medication to assist me in managing chronic pain that has not responded to other treatments. The risks, side effects, and benefits have been explained to me, and I agree to the following conditions of opioid treatment. Failure to adhere to these conditions will result in discontinuing the medication.

  1. The medication must be safe and effective. The goal is to use the lowest dose that is both safe and effective.
  2. The medication must assist me to function better. If my activity level or general function gets worse, the medication will be changed or discontinued.
  3. I will participate in other treatments that Dr ____________ recommends and will be ready to taper or discontinue the opioid medication as other effective treatments become available.
  4. I will take my medications exactly as prescribed and will not change the medication dosage or schedule without Dr ____________’s approval.
  5. I will keep regular appointments at the pain clinic.
  6. One doctor. All opioid and other controlled drugs for pain must be prescribed only by Dr __________.
  7. If I have another condition that requires the prescription of a controlled drug (narcotics, tranquilizers, barbiturates, or stimulants) or if I am hospitalized for any reason, I will inform the pain clinic within one business day.
  8. I will designate one pharmacy where all my prescriptions will be filled.
  9. I understand that lost or stolen prescriptions will not be replaced, and I will not request early refills.
  10. I agree to abstain from all illegal and recreational drugs and will provide urine or blood specimens at the doctor’s request to monitor my compliance.

    Signature: ___________________________________

    Date: _______________________________________

    Signature: ___________________________________

    Date: _______________________________________
    (Chronic Pain Management staff)

Memantine and Tiagabine

Two drugs typically used in the treatment of neurologic disease, memantine and tiagabine, show potential in 2 different pain settings — migraine and fibromyalgia, respectively. In the first study, Sorensen and Jenson explored memantine, which is approved for the treatment of Alzheimer’s disease, as a prophylactic agent for reducing the frequency of migraine. The 18 patients in the study had been refractory to a variety of other prophylactic agents and acute migraine therapies. However, 11 of the patients described their results as excellent and 4 as good. Sorensen also investigated the anticonvulsant tiagabine as a treatment for primary fibromyalgia syndrome. The short-form of the McGill Pain Questionnaire was used. Again, the 11 patients had not responded to a variety of standard treatments, including opiates, NSAIDs, tricyclic antidepressants, and another anticonvulsant — gabapentin. In this case, 6 patients reported an excellent result and 1 reported a good result, again with the McGill short form. One patient discontinued due to nausea and sedation, and 1 patient withdrew due to a poor response. Dr. Sorensen stressed that further investigation would be necessary with both therapies, although the initial results are promising.

A pain doctor’s drug trafficking conviction sets a chilling precedent

Great article written by Jacob Sullum on Reason

I have to admit I’m impressed by the achievement of the federal prosecutors who call McLean, Virginia, pain doctor William Hurwitz “a major and deadly drug dealer.” Although the evidence they presented in his trial made it clear Hurwitz was not a drug trafficker, they still managed to convict him of drug trafficking.

The prosecutors did not dispute that Hurwitz had helped hundreds of patients recover their lives by prescribing the high doses of narcotics they needed to control their chronic pain. Instead they pointed to the small minority of his patientsó5 to 10 percent, by his attorneys’ estimateówho were misusing the painkillers he prescribed, selling them on the black market, or both.

The prosecutors did not claim Hurwitz, who faces a possible life sentence, got so much as a dime from illegal drug sales. Instead they pointed to his income as a physician, which they said was boosted by fees from patients who were faking or exaggerating their pain.

read this article at https://www.reason.com/sullum/121704.shtml”

Doctor William Hurwitz office website

“The Police State of Medicine”, Remarks By Dr. William Hurwitz
How does the police-state of medicine affect medical care? and…What can we do about it?

Defend Chronic Pain Treatment

One of the saddest and least noticed consequences of the war on drugs is the under-treatment and non-treatment of chronic pain. Literally hundreds of thousands of patients endure needless agony — in some cases turning to suicide as the only available form of relief — because they could not find a doctor willing to prescribe adequate doses of narcotics for them.

The problem is two-fold: widespread ignorance on the part of physicians on chronic pain treatment; and a threatening law enforcement bureaucracy that can ruin or even incarcerate doctors whom they see as being too liberal with their prescriptions. These two factors play into each other to perpetuate a situation in which denial of pain relief is standard practice.

H.R. 3015 Continues War Against Pain Patients and Doctors

Michael Arnold Glueck, M.D., and Robert J. Cihak, M.D., The Medicine Men

Tuesday, Nov. 23, 2004

The current Congress has a few lame ducks, but they’re still mighty busy birds – trying to push through lots of big legislation such as 1,000 pages of a $338 billion omnibus spending bill.

They’re also hoping that little bills zip right through, below the public’s radar ñ bills such as H.R. 3015, which targets physicians and pharmacists in the take-no-prisoners war on pain drugs and patients suffering chronic pain.

H.R. 3015, the National All Schedules Prescription Electronic Reporting Act, passed in the U.S. House of Representatives in October. It’s now before the Senate, where it’s slated for a voice vote before the current session of Congress expires on January 2, 2005. A voice vote is a way to pass a bill quickly without a record of which way each senator voted.

This bill would encourage states to establish programs requiring physicians and other providers such as pharmacists to report any and every prescription for a wide range of commonly prescribed drugs, including pain medications and antidepressants. In addition to the medicine and dose, the doctor would have to give the government the patient’s name, address and telephone number.

This private prescription information would then become part of a national computer database, available to the police and also possibly to employers, newspapers, blackmailers or anybody else curious about such information.

The patient would not even know about the release of this prescription information, much less consent to its release or review. Police would have access to personal prescription information without having probable cause to believe a crime had been committed and without having to convince a judge to issue a search warrant.

Drug Enforcement Administration (DEA) agents and state licensure boards already have great powers. They currently can get information on prescriptions written for controlled substances and have sweeping authority to investigate anybody they choose and to prosecute doctors for prescribing more painkillers than agents think appropriate.

HR 3015 would dramatically enhance the reach of police and DEA agents into the privacy of doctors and patients.

Some government officials liken doctors to terrorists, and want equal judicial vigor in pursuing doctors. For example, according to a September press release from the Association of American Physicians and Surgeons, Assistant U.S. Attorney Gene Rossi declared to a reporter that “our office will try our best to root out [certain doctors] like the Taliban. Stay tuned.”

In opposition to the bill, Rep. Ron Paul, M.D., of Texas said HR 3015 “is yet another unjustifiable attempt by the federal government to use the war on drugs as an excuse for invading the privacy and liberties of the American people and for expanding the federal government’s disastrous micromanagement of medical care.”

He pointed out that the government is embarking on a “war on pain patients and their doctors” that “has already resulted in the harassment and prosecution of many doctors … whose only ‘crime’ is prescribing legal medication … to relieve their patients’ pain. These prosecutions, in turn, have scared other doctors so that they are unwilling to prescribe an adequate amount of pain medication, or even any pain medication, for their suffering patients.”

Could it be that government agents are going after innocent and hard-working doctors because the doctors are easy targets? Are real criminals going free because these same government agents find it too much work to break through the complicated logistic and legal defenses that real criminals sometimes build and hide behind?

Rather than giving non-medical officials more authority, power and money, Congress and the president should restrain the DEA from essentially telling doctors how to practice medicine.

Rather than using resources to send trained actors feigning pain to entrap doctors, the DEA and other agencies should communicate and cooperate with doctors.

To further this goal, the Association of American Physicians and Surgeons (AAPS) recently developed a three-point “Communicate and Cooperate” proposal to encourage physicians and law enforcement to work together to prevent prescription drug abuse. The proposal includes several ways law enforcement agents can work with doctors, such as:

1. Working together to track suspected drug abusers. To balance current laws requiring doctors to provide information about suspected abusers to the government, government agencies would notify doctors about suspicious patient behavior such as contact with known drug dealers or abusers.

2. Reviewing possible cases with professional medical boards before filing charges in court. Doctors would review a physician’s practice with police before non-medical prosecutors would file criminal charges. This would help prevent embarrassing errors by government agents and would prevent worsening the current shortage of doctors willing to adequately treat patients with chronic and painful medical conditions.

3. Mutual training of law enforcement and medical personnel. Law enforcement people would educate doctors about recognizing patterns of illegal activity and criminal intent; doctors would educate police about modern pain treatment.

And why is the U.S. Senate vote scheduled for only a “yea” or “nay” voice vote, without recording which senator voted which way? One reason is so that senators can’t be held to account for their votes.

As Rep. Paul says, “Instead of further eroding our medical privacy, Congress should take steps to protect it.”

Please let your senators know what you think, before it’s too late.

Editor’s Note: Robert J. Cihak wrote this week’s column.

* * * * * *
Robert J. Cihak, M.D., is a Senior Fellow and Board Member of the Discovery Institute and a past president of the Association of American Physicians and Surgeons. Michael Arnold Glueck, M.D., is a multiple-award-winning writer who comments on medical-legal issues.

Contact Drs. Glueck and Cihak by e-mail.

this is reposted from braintalk.org forum

Sugar treatments for chronic musculoskeletal pain

News 10 has an article about Prolotherapy, which is use a dextrose (sugar water) solution, which is injected into the ligament or tendon where it attaches to the bone. This causes a localized inflammation in these weak areas which then increases the blood supply and flow of nutrients and stimulates the tissue to repair itself.

Part of the theory is the injections cause an inflammation that causes healing, and anti-inflammatory drugs stop healing process.

They also list this link to Magaziner Center in Cherry Hill, N.J. and a phone number at Information on Prolotherapy Injections for Chronic Pain: (856) 424-8222

History of Medicare’s Prolotherapy Coverage Policy

The Coverage Issues Manual (CIM) ’35-13, “Prolotherapy, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing Agents – Not Covered,” states that the medical effectiveness of these therapies has not been verified by scientifically controlled studies, and therefore, cannot be covered by the Social Security Act, ‘1862(a)(1), as a “reasonable and necessary” treatment. This policy of non-coverage along with an erroneous Administrative Law Judge (ALJ) opinion issued in favor of Irwin Abraham, MD, in December 1997, on behalf of a Medicare beneficiary, prompted Dr. Abraham to request a national coverage decision reversing the current policy of non-coverage.

Prolotherapy was last examined for coverage by the Health Care Financing Administration (HCFA) in September 1992. The request had been generated by a beneficiary claiming a benefit from the prolotherapy treatments she had been receiving. HCFA received a number of anecdotal accounts of significant benefit derived from prolotherapy treatments, but when a literature search was conducted it failed to produce any scientifically sound studies on which to base a coverage decision.

The ALJ decision in favor of Dr. Abraham was based on Dr. Abraham’s ability to successfully bill HCFA under the CPT code 20550, “Injection, tendon sheath, ligament, trigger points or ganglion cyst” in the past. However, after the carrier identified the treatment of Dr. Abraham’s patient as prolotherapy, the carrier denied further payment. The ALJ reasoned that because the treatment had been paid for in the past, the carrier was estopped from further payment for the same procedure on the same patient who claims a benefit from the treatment. The ALJ further reasoned that payment for this treatment in the past and the teaching of this method in some medical schools is sufficient evidence that HCFA had modified its policy regarding prolotherapy. Unfortunately, the ALJ did not address the possibility that the carrier had mistakenly paid for the treatment before recognizing it as the non-covered prolotherapy. Furthermore, because the carrier failed to submit evidence that prolotherapy was indeed experimental and investigational, the ALJ determined that without advance notice to the beneficiary that the procedure was non-covered, Medicare would cover the treatment as reasonable and necessary.

HCFA conducted a new electronic literature search using MEDLINE and Ovid. The results only provided editorial articles devoid of any new scientific research. Also, HCFA staff searched the internet and contacted the American Association of Osteopaths for a complete list of current scientific evidence on the efficacy of prolotherapy. None of these efforts produced significant evidence to support the coverage request.

Analysis of Scientific Evidence

In light of the aforementioned ALJ decision, Dr. Abraham’s confusion regarding the policy here is just; however, an ALJ decision is neither binding nor precedent setting on HCFA’s national coverage decisions. Dr. Abraham supplied HCFA with five articles, two of which are clinical trials that support his request for coverage of prolotherapy. Neither of these articles contain sufficient evidence to persuade HCFA to alter the policy now in place.

The Ongley et al. article: “A New approach to the Treatment of Chronic Low Back Pain,” published in The Lancet, July 1987, studied 81 patients with chronic low back pain with an average duration of ten years in a double-blinded study to compare prolotherapy injections with a non-proliferant injectable course of therapy. Forty of the 81 patients received a regimen of forceful spinal manipulation and injections of a dextrose-glycerine-phenol solution. The 41 patients in the placebo group received less extensive initial local anesthesia (<10 ml 0.5% lignocaine compared with infiltration of 60 ml 0.5% lignocaine in treatment group), a non-forceful manipulation and saline as a substitute for the proliferant used in the experimental group. Also, the experimental group on the first day received a regimen including infiltration of triamcinolone (an anti-inflammatory) into the gluteus medius origin, whereas the placebo group only received lignocaine into the gluteus medius origin. The program included exercises in both groups to encourage the synthesis of the new cells with existing connective tissue. While the authors concluded that "the experimental regimen is a safe and effective treatment for chronic low back pain that has not responded to other conservative forms of treatment," they write earlier in the body of the results section of the paper that "(i)ndependent evaluation of physical signs revealed no significant differences between the groups after treatment."

The Ongley study fails to support the coverage of prolotherapy for a number of reasons. The authors report a subjective improvement in pain amelioration, but they fail to supply any persuasive objective criteria on which to base a coverage decision that must be grounded in scientifically valid evidence. Even the authors acknowledge in their conclusion “(f)uture studies may be needed to analyse [sic] the relative import of each component of the overall procedure.” Since the authors chose to provide the participants with manipulation, exercises and anesthesia in addition to the proliferant and saline injections, it is difficult, if not impossible, to isolate the component of the treatment which gave the participants the reported relief.

Establishing a link between the subjective improvement in pain management and a particular regimen is problematical because the participants in the experimental group received a different preparation course with more anesthesia and a forceful manipulation as opposed to the placebo group’s faux manipulation. Since the study did not treat the proliferant injections as a single variable, there is no way to positively identify prolotherapy as the cause of the pain relief rather than the forceful manipulation. Also, because Medicare currently covers forceful manipulation and massage therapy by a qualified provider, HCFA would need evidence that the addition of another variable, such as prolotherapy, to a patient’s course of treatment would provide greater benefit than that which is currently covered. Furthermore, even if the results concluded that the benefit in pain reduction could be positively attributed to prolotherapy, the sample size of 81 patients is really an insufficient number on which to base a positive national coverage decision.

The more recent study submitted by Dr. Abraham also falls short of the requisite level of evidence needed for a national coverage decision. The Klein et al. study, “A Randomized Double-Blind Trial of Dextrose-Glycerine-Phenol Injections for Chronic, Low Back Pain” published in 1993, fails in much the same way as the Ongley study before it. Again, the number of participants is small; therefore it would be difficult to use the results in support of a newly crafted national coverage decision.

The Klein study was comprised of 79 patients, 39 of which were placed in the proliferant group. Thirty of 39 patients in the proliferant group achieved a 50% or greater diminution in subjective pain or disability. The control group was not a true placebo because “the patients received four of the five active interventions of the full treatment regimen and demonstrated statistically significant within-group improvements compared to baseline disability and pain scores.” Twenty-one of 40 patients in the placebo group reported a 50% or greater diminution in subjective pain and disability scores. A response of more than 50% of patients in the control group reporting improvement suggests that an actual treatment effect rather than a pure placebo response occurred. Even the authors note, “(t)he interventions shared by both treatment groups, including exercises, injection of local anesthetics, repeated needling, and manipulation may all enhance the success of the procedure, but the relative contribution of each intervention requires further study.”

The authors identify that further studies are needed to show greater improvement in treating pain with prolotherapy because “the statistical significance was only borderline” when the experimental group was compared to the control group. Also, “objective testing of range of motion, isometric strength, and velocity of movement showed significant improvements in both groups following treatment, but did not favor either” the proliferant or the control group. Further, “the MRI and CT scans showed significant abnormalities in both groups, but these did not correlate with subjective complaints and were not predictive of response to treatment.”

A total of 160 patients studied over the past twelve years, with only 79 of the patients receiving the proposed treatment, is not a large enough sample to support a change in the coverage policy. More studies with larger control and experimental groups must be evaluated using regimens designed to isolate variables and correlate them to positive results. Ideally, these studies would consist of improvements in both objective and subjective measurement tools. However, substantial and statistically significant improvements in subjective pain scores could be persuasive if HCFA could attribute the patient benefit to the prolotherapy regimen.

ClinicalTrials.gov shows an closed study “Joint Injections for Osteoarthritic Knee Pain” to determine whether prolotherapy can decrease pain and disability from knee osteoarthritis.

Doctors must balance pain relief, fear of addiction

Some doctors won’t prescribe them.

But even for those who do, the decision to write a prescription for a potentially addictive, high-powered pain killer like oxycodone is never without some trepidation, according to several doctors who attended a lecture on “Addiction Risk Assessment” at Holyoke Medical Center Sept. 14.

While drugs like oxycodone, morphine or fentanyl are necessary to relieve very real chronic and acute pain in patients, law enforcement has found the potent medicines are also readily abused, particularly among the young. The 2003 National Survey on Drug Use and Health found a 15-percent rise in prescription drug abuse by people 18 to 25.

“You are in a precarious situation,” she said. “You need to make sure that people do not suffer in pain as well as make sure the medicine does not get into the wrong hands … It is a challenge.”