TheMaji on PARENTS: KEEP YOUR KIDS AWAY FROM FDA APPROVED DRUGS
Much of the medical marijuana discussion has focused on the safety of marijuana compared to the safety of FDA-approved drugs. On June 24, 2005 ProCon.org sent a Freedom of Information Act (FOIA) request to the US Food and Drug Administration (FDA) to find the number of deaths caused by marijuana compared to the number of deaths caused by 17 FDA-approved drugs. Twelve of these FDA-approved drugs were chosen because they are commonly prescribed in place of medical marijuana, while the remaining five FDA-approved drugs were randomly selected because they are widely used and recognized by the general public.
We chose Jan. 1, 1997 as our starting date as it is the beginning of the first year following the Nov. 1996 approval of the first state medical marijuana laws (such as California’s Proposition 215). The FDA reports we read from Sep. 13, 2005 to Oct. 14, 2005 included drug deaths “to present”, which was the date each report was compiled for our request. We cut off the counting as of June 30, 2005 to provide a uniform end-date to the various reports.
On Aug. 25, 2005 the FDA sent us 12 CDs and five printed reports containing copies of their Adverse Event Reporting System (AERS) report on each drug requested. These reports included all adverse events reported to the FDA, only a portion of which included deaths. We manually counted the number of deaths reported on each drug from the FDA-supplied information.
A review of the FDA Adverse Events reports also revealed some deaths where marijuana was at least a concomitant drug (a drug also used at the time of death) in some cases. On Oct. 14, 2005 we used the Freedom of Information Act to request a copy of the adverse events reported deaths for marijuana/cannabis. We received those reports on Aug. 3, 2006 in the form of three additional CDs.
 II. Cause of Death Categories & Definitions |
The FDA AERS reports rely on health professionals to detect an “adverse event” and attribute that event to the drug, and then to voluntarily report that effect to either the FDA or the drug manufacturer. The drug firm, by law, must report that event to the FDA. The FDA states “ninety percent of the FDA’s reports are received from drug manufacturers” on page one of its “Adverse Event Reporting System (AERS) Brief Description with Caveats of System.”
(PDF 2.7 MB)
Select instructions on how to report adverse events, as per the FDA’s AERS Form Instructions
- Adverse Event: Any incident where the use of a medication (drug or biologic, including HCT/P), at any dose, a medical device (including in vitro diagnostics) or a special nutritional product (e.g., dietary supplement, infant formula or medical food) is suspected to have resulted in an adverse outcome in a patient.
- Death: Check only if you suspect that the death was an outcome of the adverse event, and include the date if known. Do not check if:
- The patient died while using a medical product, but there was no suspected association between the death and
- A fetus is aborted because of a congenital anomaly (birth defect), or is miscarried
- Suspect Product(s): A suspect product is one that you suspect is associated with the adverse event.Up to two (2) suspect products may be reported on one form (#1=first suspect product, #2=second suspect product). Attach an additional form if there were more than two suspect products associated with the reported adverse event.
- To report: it is not necessary to be certain of a cause/effect relationship between the adverse event and the use of the medical product(s) in question. Suspicion of an association is sufficient reason to report. Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event.
| III. FDA Disclaimer of Information |
Included in the 15 CDs and five printed reports from the FDA was the following disclosure:
“The information contained in the reports has not been scientifically or otherwise verified. For any given report there is no certainty that the suspected drug caused the reaction. This is because physicians are encouraged to report suspected reactions. The event may have been related to the underlying disease for which the drug was given to concurrent drugs being taken or may have occurred by chance at the same time the suspected drug was taken.
Numbers from these data must be carefully interpreted as reported rates and not occurrence rates. True incidence rates cannot be determined from this database. Comparisons of drugs cannot be made from these data.”
— July 18, 20/05 – FDA Office of Pharmacoepidemiology and Statistical Science, “Adverse Event Reporting System (AERS) Brief Description with Caveats of System”[Editor’s Note – ProCon.org makes no claim that the data below reflects occurrence rates. The information is presented for our readers’ benefit who may feel that the relative comparisons have value. ProCon.org attempted to find the total number of users of each of these drugs by contacting the FDA, pharmaceutical trade organizations, and the actual drug manufacturers. We either did not receive a response or were told the information was proprietary or otherwise unavailable]
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DRUG CLASSIFICATION
|
Specific
Drugs per Category |
Primary
Suspect of the Death |
Secondary
Suspect (contributing to death) |
Total Deaths Reported
1/1/97 – 6/30/05 |
|
| A. MARIJUANA also known as: Cannabis sativa L |
0
|
279
|
279
|
||
| B. ANTI-EMETICS (used to treat vomiting) |
196
|
429
|
625
|
||
| C. ANTI-SPASMODICS (used to treat muscle spasms) |
118
|
56
|
174
|
||
| D. ANTI-PSYCHOTICS (used to treat psychosis) |
1,593
|
702
|
2,295
|
||
| E. OTHER POPULAR DRUGS (used to treat various conditions including ADD, depression, narcolepsy, erectile dysfunction, and pain) |
8,101
|
492
|
8,593
|
||
F. TOTALS of A-E |
Number
of Drugs in Total |
Primary
Suspect of the Death |
Secondary
Suspect (contributing to death) |
Total Deaths Reported
1/1/97 – 6/30/05 |
|
|
1
|
0
|
279
|
279
|
|
|
17
|
10,008
|
1,679
|
11,687
|
|
| V. Chart of Deaths from Marijuana and 17 FDA-Approved Drugs |
| F. TOTALS of A-E |
Primary Suspect
|
Secondary Suspect
|
Total Deaths Reported
1/1/97 – 6/30/05 |
|
|
0
|
279
|
279
|
|
|
10,008
|
1,679
|
11,687
|
|
|
Has marijuana caused any deaths?
|
|
|
General Reference (not clearly pro or con)
The Substance Abuse and Mental Health Services Administration’s (SAMHSA) 2003 report Mortality Data from the Drug Abuse Warning Network, 2001 (1.5 MB)
|
|
|
PRO (Yes)
|
CON (No)
|
Thomas Geller, MD, Associate Professor of Child Neurology at the Saint Louis University Health Sciences Center, et al., wrote the following in their Apr. 4, 2004 article titled “Cerebellar Infarction in Adolescent Males Associated with Acute Marijuana Use,” (560 KB)  published in the journal Pediatrics:
Liliana Bachs, MD, Senior Medical Officer at the Norwegian Institute of Public Health, et al., wrote the following in their Dec. 27, 2001 article titled “Acute Cardiovascular Fatalities Following Cannabis Use,” published in the journal Forensic Science International:
[Editor’s Note: Dr. Bachs clarified the findings from her Dec. 27, 2001 study reported above in a Nov. 28, 2005 email to ProCon.org, as quoted below.
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Stephen Sidney, MD, Associate Director for Clinical Research at Kaiser Permanente, wrote the following in his Sep. 20, 2003 article titled “Comparing Cannabis with Tobacco — Again,” published in the British Medical Journal:
Joycelyn Elders, MD, former US Surgeon General, wrote the following in her Mar. 26, 2004 editorial published in the Providence Journal:
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VII. Full Text of All 20 FDA “Adverse Event” Reports
[Please note that some of these PDF files exceed 5 megabytes and may take several minutes to load]
