Charles Stephens MD, Ph.D
The degree of potential hazards associated with widespread misuse of nitrite odorants as poppers has been a contentious issue, most notably since the early 1970's, when their use as the primary ingredient in nitrite-based room odorants began.
Initial concerns centered around general issues of safety, while later concerns, raised immediately after the discovery of AIDS in 1981, centered around whether inhalation of nitrites contributed in any way to AIDS or any of its associated diseases, in particular, a possible link between nitrites and Kaposi's sarcoma – which to this day is still debated by some.
Prior to 1969 the alkyl nitrites, specifically amyl nitrite, had been used in medicine for the relief of angina pectoris since 1867. In September 1960 the United States Food and Drug Administration (FDA) eliminated the prescription requirement for amyl nitrite because amyl nitrite was considered so harmless it was safe for over-the-counter sales.
But, by the mid-1970's, following an upsurge in the then-unregulated sale of nitrite room odorant products, news mentions about poppers, which typically centered around their use for alleged pleasurable sensations (particularly as aphrodisiacs), began to appear in print and on television, most often questioning their safety. In an October 1977 Wall Street Journal front page article on the poppers industry, Los Angeles bureau chief, Steven Sansweet, wrote that poppers were "a new way to giggle and glow". Several months later, in July 1978, a TIME MAGAZINE feature on poppers suggested that the industry had become a $50 million per-year business.
The controversy accelerated in May, 1977 when the State of Connecticut proposed to ban their sale. The State claimed that there existed a reasonable probability of substantial personal injury resulting from the misuse of these products. The State's concern was the direct concentrated inhalation of these products for the purpose of obtaining a physiological effect.
Based on these concerns, and the then-limited amount of current, consolidated information available, in 1977 a research program was initiated by a group of Canadian and U.S. researchers and medical doctors, some with extensive expertise in the area of the alkyl nitrites. The report remains today as the most authoritative source of credible information on these compounds.
At the onset, objectives were defined and a survey of pertinent literature was conducted. United States Government agencies and private companies with relevant information were questioned. When available data were doubtful or insufficient, a series of research projects was conducted under appropriate auspices.
The research group included Professor Mark Nickerson* of McGill University, in Montreal, Canada. Professor Nickerson was the retired Chairman of the McGill Department of Pharmacology and Therapeutics. In 1977 Dr. Nickerson had, for nearly forty years, been the author of the Nitrite Vasodilator chapter of Goodman & Gillman's standard textbook of pharmacology (The 'Bible" most doctors refer to when treating their patients with drugs). Professor Nickerson has been called "...perhaps the most eminent pharmacologist of the twentieth century". Professor John Parker**, of Queen's University, had at the time been Chairman of the Division of Cardiology for nearly a decade. Nitrite vasodilators, including amyl, butyl, and isobutyl nitrite, had long been a subject of his special study. Dr. Parker is recognized as the world’s leading expert on nitrates and nitrate tolerance. He has published several articles in the New England Journal of Medicine, the Journal of the American College of Cardiology, the American Journal of Cardiology, Circulation, and many other major journals. Professor Thomas Lowry was a psychiatrist who had done extensive research into drugs and sexual behavior. Professor Edward Swenson was a specialist in pulmonary disease who had written more than 80 publications on the subject.
The researchers obtained a great deal of statistical data from epidemiological records which were maintained by agencies of the United States Federal Government, and from the records of Burroughs Wellcome Company and Eli Lilly and Company, both of which in 1977 were the world's largest producers of alkyl nitrites for medicinal use. The research group also obtained much confidential information concerning RUSH® and other similar products, from the files of Pacific Western Distributing Corporation of San Francisco, then the world's largest producer of nitrite-based room odorants.
The research project took nearly two years to accomplish, and resulted in a report consolidating, clarifying, and expanding the pharmacological, toxicological and sociological data regarding these nitrites. (ISOBUTYL NITRITE and Related Compounds, by Mark Nickerson, John O. Parker, Thomas P. Lowry and Edward W. Swenson, ©1979 by Pharmex, Ltd. All rights reserved)
Writing in the "Summary and Conclusions" chapter of their 103-page report, the authors noted that, by 1979, the volatile nitrites had been in use for more than a century. During this entire period of time, their medical use was predominantly in patients with coronary disease. Even in this high-risk group, strict control of frequency of administration was considered unnecessary.
In 1979, reports of the non-medical use of the volatile nitrites dated back nearly fifty years, and during the pervious twenty years, there had been increasing and widespread uncontrolled use of these compounds.
"The nitrites exert short-lived physiological effects, due primarily to their relaxing effect on smooth muscle. The consequent dilating effect on vascular tissue may lead to a transient reduction in blood pressure and increase in heart rate. The unwanted effects of these agents are associated with the vascular effects, but despite the ready availability of the nitrites and their widespread distribution and use, there have been no substantiated reports of serious injury or death secondary to this uncontrolled use. There is no established relationship between the pharmacology or toxicology of the inhalation of the alkyl nitrites and the inhalation of nitrous oxide, or to the suggested carcinogenesis related to the ingestion of inorganic nitrites in foods.
Despite the substantial and increasing uncontrolled sale and use of pharmaceutical amyl nitrite during the decade of the 1960's, no manufacturers received reports of injuries. Based on statistics reported by the United States Government-managed Drug Abuse Warning Network (DAWN) project, during the five-year period ending June 30, 1978, more than 18,036 persons were admitted to hospitals and more than 933 died from "drug abuse" directly attributed to specific prescription drugs. Of these, three admissions and no deaths were attributed to amyl nitrite. During the same period, more than 23,666 persons were admitted to hospitals and 3,754 died from "drug abuse" directly attributed to specific non-prescription drugs ranging from glues and housekeeping aids, to aerosol deodorants. Despite sales estimated at over 12,000,000 bottles during this period, no one was reported injured and no fatalities were reported from consumer products (scents, odorizers) containing butyl or isobutyl nitrite.
During the same 1973-78 period, the National Electronic Injury Surveillance System (NEISS) managed by the United States Consumer Products Safety Commission, estimated that out of 44,658,823 injuries attributable to consumer products, 698,554 injuries were caused by "Home and Family Maintenance Products". In this group, which includes household odorizers and deodorizers, there were estimated to have been 6,627 injuries from chemical deodorizers, and none from odorizers or scents including those containing butyl or isobutyl nitrite.
Amyl nitrite is among the safest medications known to man. The pharmacology and toxicology of the other volatile nitrites, including butyl and isobutyl nitrite, which are in use in consumer or household products, is almost identical. Further Regulation or control would be unnecessary for the protection of the public health. Based on the data, it is difficult to envision any product with a better record of public safety.
The researchers ended the "Summary and Conclusions" chapter of their report by stating: “A definition of safety as being totally free of toxicity has no meaning in toxicology, as all substances are toxic at some level of use. No important acute or chronic toxic effects have been demonstrated with the volatile nitrites, and their use in an uncontrolled and unregulated fashion has proven to be safe."
Also in1979, independent of and entirely unknown to the Isobutyl Nitrite and Related Compounds research project, a report on isobutyl nitrite was presented to Canada’s Product Safety Branch, Consumer and Corporate Affairs agency. In his July 30,1979 cover letter to the Canadian Government, Radhey L. Singhal, Ph.D., the Professor and Chairmen Department of Pharmacology, University of Ottawa said: “As stated in our report, we have concluded that occasional inhalation of isobutyl nitrite for its ‘inebriant’ effect in a recreational context is unlikely to pose a health hazard.”
Two years later, on January 30, 1981, Ray Hamilton, Director of Recall and Litigation, Bureau of Drugs, Food and Drug Administration (FDA), in an official FDA statement clarifying the agency’s feelings on the subject of butyl nitrite, said: “The FDA does not plan to devote resources to a project involving room odorizers containing alkyl nitrites because of the absence of demonstrable hazard.”
Later that same year, on September 9, 1981, following a lengthy investigation, the United States Consumer Product Safety Commission (CPSC) voted unanimously against controlling alkyl nitrites. The Commission found insufficient evidence to support the allegation of behavior disorder associated with alkyl nitrite inhalation. It also found that injury data did not indicate a significant risk of personal injury or illness.
By 1981 the controversy over the potential dangers of poppers seemed to have been settled. Consumer odorizer products containing alkyl nitrites had built a significant record of public safety, a record that was recognized by researchers and government agencies alike.
==The Battle Over the AIDS Connection==
However, and also in 1981, the beginning of the AIDS crisis fueled an hysteria about poppers, around the issue of whether poppers were a factor in causing AIDS or any of it’s opportunistic infections – particularly Kaposi's sarcoma. As a result, during the ten years between 1981 and 1991, a small band of poppers/AIDS-connection proponents waged an intensive and unrelenting war against poppers which ultimately resulted in the United States Congress banning the sale of alkyl nitrite poppers in the U.S. in 1991.
But, was banning nitrite odorants (poppers) justified? Some still believe it was, but there’s a growing consensus that the early concerns over whether poppers caused AIDS or any of its opportunistic infections, including KS, were politically exploited by those ever keen to fan any spark of controversy, or anti-popper zealots riding their favorite hypothesis saddled up as fact.
By 1986 the poppers/AIDS/KS connection had been essentially discounted by most every credible AIDS researcher in the world. However, on the periphery of the AIDS research community, a handful of researchers would continue to write grants to get funding for their never-ending efforts to blame poppers for AIDS and a host of other ills. Seemingly spurred on by anti-popper zealots with a potentially vested interests in an ongoing campaign against poppers, these ‘studies’ would be mostly small scale, non-peer reviewed, never replicated and would provide conflicting results essentially canceling themselves out. But they conveniently served to provide the underpinning of a relentless anti-popper campaign that would push on through the next decade, and beyond. A campaign many would come to view as being based on misinformation and disinformation.
That same year, no less an expert on AIDS than researcher Bruce Voeller, Ph.D., the man who gave AIDS its name, publicly revealed his disgust with the anti-poppers campaign.
As President of the Mariposa Education & Research Foundation, headquartered in Los Angeles, Dr. Voeller addressed the poppers/AIDS controversy in the now famous “Mariposa Occasional Paper #6”, dated May 1986. Titled “Are Poppers Safe?”, the Mariposa document explored the controversy that had been raging over the prior five years, and laid bare the faults inherent in the anti-popper campaign, while explaining the potential dangers in continuing the campaign.
Writing in Mariposa Occasional Paper #6”, Dr. Voeller said that “when mediocre or even plain bad scientific research is politically exploited by AIDS institutions eager to appear to be earning their keep, or by the media -- ever keen to fan any spark of controversy, or zealots riding their favorite hypothesis saddled up as fact, the public is in danger."
Basing public policy on inadequate science is particularly inappropriate.
All this appears to be fueling the hysteria surrounding the use of volatile nitrites or "poppers", especially the issue whether "poppers" are a factor in causing AIDS or in suppressing the immune system.
As a scientist current with AIDS research and who has reviewed the extensive literature on nitrite use I can not assure you that "poppers" are harmless, any more than I can assure you aspirin is; but, neither have I found grounds to tell you "poppers" are harmful.
I can assure you, however, that the existing scientific studies on this topic do not justify the widespread belief that “poppers" have been shown to help cause AIDS, or cause anything else for that matter. My viewpoint is shared by other qualified persons, including prominent cardiologist John 0. Parker, M.D., as well as James Mosley, M.D., the University of Southern California Medical School professor who heads the federal government's largest, multi-million dollar program studying the AIDS virus and the nation's blood supply. Each of these physicians has provided public testimony in recent months at governmental hearings considering the banning of “poppers". Each had reviewed the evidence and stated under oath that they regard the claims of danger to be ill founded.
I can also tell you that the intense campaigns against the use of volatile nitrites conducted by Hank Wilson in San Francisco and John Lauritsen in New York, are slim in scientific merit.
Space limits for this article do not allow reviewing each of the many published papers on poppers. However, a critical look at three of the most frequently cited ones may whet your awareness of the need for a more substantial weighing of the evidence than has been provided by the "popper"-ban advocates. A look at these three papers is representative, in my view, of the best of what has been published.
Hersh and Newell and their colleagues(1) at M.D. Anderson Hospital in Houston, studied the effect of butyl nitrite (“poppers") on laboratory (in vitro) cultures of white blood cells--cell types important in the body's immune response to infection.
They reported that many of these cells were killed when left for 24 hours in the presence of one percent added butyl nitrite, whereas at 1/2 that concentration (i.e., 0.5 percent) or less the "cell count and viability were unaffected." [emphasis added] In other words, a small change in concentration dramatically eliminated the toxic effect. They also wrote that at 0.5 percent several of the cells' immunological responses were inhibited. However, again only a generally small inhibition could be detected at slightly lower concentration (0.01 percent).
The authors warned of the need for caution in evaluation of the significance of their results in real life applications(2): "The data suggest but do not prove that the agents may be immunosuppressive in vivo [in living animals]." Despite their own sound advice, a paragraph later in their text, they ignore their advice stating: "these in vitro studies strongly suggest that the inhalant nitrites may indeed be dangerous, and their use should be condemned by those physicians who treat patients who use these drugs regularly." [Note that they use the term "condemned”, a judgmental, non-scientific word, rather than one such as “cautioned about."]
Although it is true that instructive information about the effect of use of a drug on people is sometimes gained by in vitro (test tube) studies, more often than not such work proves non relevant. Most people are aware, for instance, of the large numbers of “promising" drugs discovered in the lab and reported in the press but which then prove unworkable when tested on live patients. This drug failure, in moving from the test tube to actual people, is often because very high or very low concentrations of drugs were used in the laboratory phase of the study and have little relevance to "real life" testing.
Clearly a small reduction in nitrite concentration dramatically changed the responses Newell and Hersh found. The question logically follows: how relevant is the use of their concentration of poppers to real life"?
One estimate is to calculate what Newell's one percent nitrite concentration means for an average adult male with 6 liters of blood for even transiently establishing a one percent blood level, never mind for a 24-hour one. CALCULATION: one percent of 6 liters equals 0.06 liters, or 60 milliliters (ml.) of butyl nitrite. A representative bottle contains 10 to 12 ml. of “poppers"; that is to say, about 5 or 6 bottles of "poppers" would have to be injected into a person's blood to briefly attain a one percent level ... a staggering amount of butyl nitrite!
And that's attained only if all the nitrite gets into the person's blood. Unlike adding butyl nitrite directly into Hersh and Newell's laboratory dish where the "poppers" can saturate the culture medium, only a fraction of the chemical will be absorbed at the lungs through inhalation, the common way poppers are used. As with cigarette smoke, most of what is inhaled is immediately exhaled out of the user, thus, many more bottles of butyl nitrite would be needed to achieve an inhalation level comparable to that in the laboratory study, making the bearing of Newell and Hersh's data still more remote in human relevance.
Also, the authors' laboratory results are based on 24-72 hour continuous exposure to butyl nitrite, a condition utterly without parallel in common human usage, even though some might wish that disco-ing or sex lasted that long.
I think it is instructive to consider all this information with regard to a far less politicized compound, such as aspirin. It would not be surprising to find that common household aspirin, used by generations of average Americans, would have had similar inhibitory laboratory effects if Newell and Hersh had tested one percent levels of it, too. In fact, for a rough and ready comparison, as little as 0.325 grams (gm.) of aspirin taken by some persons can cause changes in blood chemistry leading to bleeding for several days, as well as other effects. 0.3 gm. of aspirin in 6 liters of blood represents a concentration of 0.005 percent, even less than the percentage of butyl nitrite needed for an effect.
To conclude, yes, if enough "poppers" are used an effect can be forced...just as household aspirin can be forced to lethal levels.
In another study, the M.D. Anderson Hospital group(3) injected mice with "RUSH®", a commercial brand of “poppers", in order to see "real life” effects of nitrites. They inoculated the mice twice, each time with 1/4 ml. of a “poppers" solution of about 5.6 percent nitrite. That calculates to about 0.028 ml. of butyl nitrite per mouse.
How does that compare to a man? The average mouse weights about 80 gm., the average man 80,000 gm.; the weight ratio is about 1000 to 1.
Scaling up the nitrite dose used in the mice to a comparable one for a man, would thus require injecting him twice with 14 ml. of "RUSH®” -- that is a total of 28 ml., or nearly three bottles of "RUSH®". Adult humans have died from similar amounts (10 to 30 gm.) of aspirin(4). Such a massive dose of aspirin is highly toxic compared to ordinary usage. With this parallel in mind I fail to see what significance a similarly massive dose of butyl nitrite has for comparison to ordinary “popper" use.
The third research study is one of rare restraint and high integrity. The study by Haverkos et al.(5) has been widely used by "popper"-ban lobbyists to claim a link between "poppers" and AIDS, even though the authors avoid that link. In fact, they argue that of those persons who have already developed immunodeficiency, those who
have a history of using substantial amounts of “poppers", more frequently succumb to Kaposi's sarcoma (KS), whereas those with lower or no nitrite use, succumb to pneumocystis pneumonia (PCP). Ironically, the AIDS patients with KS (higher nitrite use) have a considerably longer life expectancy after diagnosis than do those with PCP (lower use).
However, in comparing a rather small sample of 47 men with KS and 20 with PCP, Haverkos found a long list of other statistically significant differences too: Men with KS were more likely to earn over $20,000 per year (!); to have had hepatitis B; use amphetamines, barbiturates, cocaine, ethyl chloride, LSD, marijuana, methaqualone; had more sexual partners. This is a formidable list of statistically significant differences.
Unable to draw any clear conclusions from these direct correlations, the authors resorted to 'multivariate analysis’, a sophisticated, but treacherous technique. It is especially tricky with small numbers of subjects, as in this study. Indeed, Haverkos and his associates themselves state that multivariate analysis only “suggests the relative importance of differences." [emphasis added]
Haverkos et al. cautiously report, "Total days of nitrite use more significantly differentiated between the disease groups than any other variable," and "interpreting the results of these analyses requires caution. The numbers of patients enrolled are small," and as the final statement in the 'discussion' section of their paper: "The association of KS with nitrites in this study may only represent correlation. In other words, nitrites may be merely a marker for other behaviors or exposures associated with their use,"
Indeed, other published multivariate studies do not confirm Haverkos et al. As the authors forthrightly and candidly admit, Marmor et al.(6) initially reported a KS-“poppers" link, "However, they [Marmor et al.] reanalyzed their data, entering additional factors, and found that still other variables appear to differentiate KS patients from controls by multivariate analysis," and Jaffe et al., at the Centers for Disease Control.(7) also reported using multivariate analysis and found that nitrite use was not significant.
Elsewhere, in the lead chapter of one of the finest new AIDS research and therapy books(8), J.J. Goedert and W.A. Blattner at the National Cancer Institute draw a very interesting conclusion from their research and that of others. While noting that in one study, "helper T-cell counts were slightly lower with frequent nitrite inhalant use; this suggests the possibility that nitrite use may be a co-factor" for AIDS or for KS, "Neither of these possibilities has been completely evaluated," and, "However, it now appears that frequent use of nitrite inhalants simply may be a surrogate marker of frequent receptive anal intercourse. This sexual activity was associated very clearly with Kaposi's sarcoma in a case-control study of homosexual men and with HTLV-III seropositivity in the cohort studies of homosexual
men in Denmark and New York City, even after statistically adjusting for the number of homosexual partners and the frequencies of nitrite inhalant use and seven other sexual practices.”
In short, the much vaunted body of research supposedly demonstrating a link between “poppers” and AIDS does not withstand close scrutiny. If a link exists it still remains to be proven.”
Dr. Voeller’s expert analysis of diverse other published and unpublished works on the issue of “poppers” and AIDS (Goedert et al., Jacobs et al., Gerblish et al., Mathur-Wage et al., and Gangadharam et al.), showed that those studies fared even less well then those he’d addressed here.
Voeller went on to say that “some of us have to tell the truth with as much objectivity as possible – some of us with the scientific research-training to evaluate the data at more than its face value”; thus leaving out, he said, “most physicians and nearly all journalists and advocate-lobbyists (such as Hank Wilson, a switchboard operator, and John Lauritsen, a poet and gay journalist, both of whom were the most vocal anti-popper proponents). He felt that “the liberties with fact taken by some who act as medical spokespeople in the AIDS crisis can only serve to undermine public trust in the scientific process.”
In the same 1996 Occasional Paper #6, Dr. Voeller made what would become a prophetic comment when he said he feared “the damage which will be done if people are boldly told, as they have been, that ‘poppers’ are ‘the drug linked with AIDS’. Too many will give up ‘poppers’ but continue with or move on to cocaine, heroin, or crystal meth. These are drugs more likely in my view to be among the AIDS-cofactors.” Twenty years later, Voeller’s fears about an upsurge in the gay community of the use of crystal meth have been borne out; the use of crystal meth has fueled a wave of new HIV/AIDS infection throughout the gay community for the past several years.
He went on to say that he was also fearful that illegalizing “poppers”, coupled with the media blitz which existed at the time, would make “poppers” the “token sacrafice”, and “legitimize” clearly dangerous drugs. Voller indicated that he’d seen gas chromatographic profiles of the purity of street “poppers”, and of the largest legitimate manufacturer’s. The latter, he said, were pure, while the street forms were like “bathtub gin”. “Illegalizing ‘poppers’”, he said, “will knock out the pure forms and make dirty street ‘poppers’ the standard item.” Since the ban on poppers in 1991, unscrupulous parties have been producing impure and potentially dangerous counterfeit copies of the major brands, including RUSH® and HARDWARE®, along with several other leading brands. (Which are still legally sold internationally, and available on the Internet)
The man who gave AIDS its name ended his comments by saying that “We either need to put the issue of ‘poppers’ behind us, or make a valid case against them through better science, so that we can turn our attention to other drugs and other potential cofactors. We’ve been too preoccupied with ‘poppers’ to the exclusion of everything else. By continuing up a wrong path, we lose time finding the right one.”
“On the AIDS clock”, he said, “time is measured in deaths.”
******************************************************
References:
(1) 1983 Cancer Research 43; 1365
(2) ibid pg. 1371
(3) 1984 Lotzova, Hersh et al., Cancer Immunol. Immunother. 17; 130-134
(4) 1985 ‘Goodman and Gilllman’, THE PHARMACOLOGICAL BASIS OF THERAPEUTICS, 7th ed.
(5) 1985 Sexually Transm. Dis. 12(4:203-220)
(6) 1982 Lancet, 1:1083-7
(7) 1983 Ann. Int. Med. 99:145-151
(8) Goedert, J.J. and Blattner, W. A. The epidemiology of AIDS and related conditions. IN: AIDS: ETIOLOGY, DIAGNOSIS, TREATMENT, AND PREVENTION. Eds.: DeVita, V.T., Hellman, S. and Rosenbert, S.A. 1985 J. B. Lippincott Company. New York
* Mark Nickerson, perhaps the most eminent pharmacologist of the twentieth century, was a Professor of Pharmacology and Therapeutics at McGill University. He joined the faculty at McGill in 1967, where he chaired his department from 1967 to 1975. He also held academic positions at the University of Manitoba, the University of Michigan, and the University of Utah. Professor Nickerson died on March 12, 1998, in Ottawa, Canada where he had moved after his retirement.
** John O. Parker, MD is Director of the Cardiovascular Laboratory at Kingston General Hospital, and Professor of Medicine at Queen’s University in Kingston, Ontario, where he also received his medical degree. Dr. Parker is recognized as the world’s leading expert on nitrates and nitrate tolerance. He has published several articles in the New England Journal of Medicine, the Journal of the American College of Cardiology, the American Journal of Cardiology, Circulation, and many other major journals.
Bruce Voeller, Ph.D. was a biologist, researcher, and founder of the Mariposa Education and Research Foundation. Voeller was perhaps best known for coining the acronym AIDS for "acquired immune deficiency syndrome," a term he used in objection to the disease's earlier label, GRID, or "gay-related immune disorder." From 1961 to 1972, he held various positions on the faculty of Rockefeller University. A prominent gay rights activist, Voeller helped found the National Gay Task Force (NGTF) in 1973 and with Jean O'Leary, served as first co-directors. He also served as President of the Gay Activists Alliance in New York City. In 1980, Voeller established the Mariposa Foundation based in Topanga, California to conduct human sexuality research, placing special emphasis on reducing the risks of sexually transmitted diseases. Voeller's research with the Mariposa Foundation centered on the reliability of various brands of condoms in preventing the spread of diseases. A result of this research was a study funded in part by the American Foundation for AIDS Research (AMFAR) and the National Institutes of Health (NIH), that ranked 31 brands of condoms under various conditions. Voeller also conductrf viral leakage studies for the then recently approved "female" condom.
Charles Stephens M.D., Ph.D., has been involved in the study of the molecular basis of immune recognition for over twenty years. He currently resides in the Republic of South Africa. The evolution of the AIDS pandemic has been of special interest to him for many years, including the areas of Kaposi's sarcoma, and the possible association of drug abuse with AIDS.
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