Speculative Studies - Opioid Use & Cancer Growth?

January 2010

Does Morphine Encourage Cancer Growth?

"Some recent scary headlines in the lay press hyped a very preliminary study in lung cancer cell lines, suggesting that use of morphine (or other opioids) in advanced cancer patients may hasten death, and that methylnaltrexone, a peripherally acting opioid antagonist, may retard cancer growth. The news reports cite "growing clinical evidence" of this phenomenon. Unfortunately, the "clinical evidence" cited is barely tenuous and the laboratory studies are very preliminary.

The news reports were based on a press release by the University of Chicago press office. It should be noted that methylnaltrexone, which is currently indicated only for opioid-induced constipation in advanced cancer patients, was developed at the University of Chicago and licensed to a pharmaceutical company.

The press release is based on a presentation at a scientific meeting. Even early research findings by well-regarded scientists must be subjected to peer review through publication in reputable scientific journals; this report is yet to be published.

The research was initiated after a small number of patients in a methylnaltrexone study lived longer than expected. Similarly, a very small number of patients with advanced cancer in an intrathecal analgesic study lived a little longer than expected (but did not reach statistical significance, and it was not a study end-point).

Three small, single-institution clinical studies are mentioned (two of them at the same institution in Ireland). Longevity related to opioid use was not a study question in any of these studies. There are multiple other factors that could have contributed to any perceived survival advantage.

There are several small studies which show that well-managed pain (using aggressive opioid treatment) in end-stage disease does not shorten life and may have a slight survival advantage in some cases (these studies did not address the direct affect of opioids on tumor growth, which is the presumed reason for the observed survival effect).

Opioid analgesics have a long and well-documented track record of relieving pain and dyspnea associated with advanced cancer, reducing suffering, and improving quality of life.

Clinical practice in any arena should not be changed based on the findings of a single study, even one that is well-designed and conducted. The findings from these studies are speculative. From a research perspective they raise interesting questions that suggest hypotheses and form the basis for future laboratory research. Based on results of those future studies, clinical trials can then be designed.

There is some fascinating science at work in this, and it will be prudent to follow its progress in the coming years. However, it would be imprudent, at best, to change current pain management practices with opioid analgesics based on this report. Patients and clinicians need to have the news reports put in perspective."

Thomas Quinn, APRN, MSN
Yale Cancer Center

OTC Medication Recall - Motrin, Benadryl, Rolaids

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare has voluntarily recalled certain lot numbers following an investigation of consumer reports of an unusual moldy, musty, or mildew-like odor. The odor was associated with temporary, non-serious gastrointestinal symptoms, including nausea, stomach pain, vomiting, and/or diarrhea.

This recall expands an earlier recall of acetaminophen 100-count bottles with EZ open caps labeled Tylenol Arthritis that began in late 2009. Some of the medications included in this expanded recall are used in the treatment of pain, like:

Children’s Motrin
Children’s Meltaway Tylenol
Benadryl
Extra Strength Tylenol
Regular Strength Tylenol
Motrin IB
Rolaids
St. Joseph Aspirin
Tylenol 8 hour

Specific lot numbers affected by this recall can be found at http://www.mcneilproductrecall.com/
To find if you are in possession of any of the affected products, look on the side of the bottle label for the lot number.

Individuals who may have ANY of these lots in their possession should:
1. Stop taking the medication.
2. Contact your healthcare provider if you have recently taken any of these medications and are experiencing symptoms as listed above or have medically-related questions.
3. Report any adverse reactions to the FDA’s MedWatch Program by:o Fax: 1-800-FDA-0178,o Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787o Internet:(Medwatch website)
4. Contact McNeil Consumer Healthcare for instructions if you wish to obtain replacement medications or a refund and also to receive information about safe disposal of these products.

The public may direct questions to McNeil Consumer Healthcare or 1-888-222-6036 (Monday-Friday, 8:00 a.m. to 10:00 p.m. Eastern time and Saturday-Sunday 9:00 a.m. to 5:00 p.m. Eastern time).

Johnson & Johnson expands voluntary recall of Tylenol Arthritis Pain caplets

Johnson & Johnson, the makers of Tylenol Arthritis Pain caplets, is expanding a voluntary recall of the product because of consumer complaints of a strange, moldy smell that has caused nausea and other ailments. The health care company, based in New Brunswick, N.J., is now recalling all 100-count bottles of the arthritis caplets with the red E-Z Open Cap. Last month, Johnson & Johnson recalled five lots of the pain medicine after consumers complained of a mildew-like odor from the pills that produced nausea, vomiting, stomach pain and diarrhea.

The pills’ musty odor comes from trace amounts of a chemical known as 2, 4, 6-tribromoanisole, according to the company, which is believed to be from the breakdown of another chemical in wooden pallets used to transport and store the drugs.

To date, the health complaints have been “temporary and nonserious,” according to a press release by McNeil Consumer Health Care, the division of J&J that sells Tylenol, although the health effects of the chemical have not been studied.Johnson & Johnson will move production of the caplets to a new facility and return the product to the market by January.

Consumers are advised to stop using the product and call the company at (888) 222-6036 for a refund. Additional information on the recall can be found online at Tylenol's Web site.