No More Tears? The Shame of Johnson & Johnson

In 1972, prisoners at Holmesburg Prison in Philadelphia were paid $3 to have their eyes held open with clamps and hooks while Johnson & Johnson’s baby shampoo was dropped into them.^[1]  In 2011, mothers of newborns were arrested when their babies tested positive for exposure to cannabis, a false result caused by the use of Johnson & Johnson’s Head-to-Toe Foaming Baby Wash.^[2] Young men have undergone mastectomies to remove breasts grown as a result of Johnson & Johnson antipsychotics, which were used as a result of Johnson & Johnson’s criminal promotion of its drugs for off-label purposes.

And now, Johnson & Johnson has announced the removal of carcinogenic chemicals from their No More Tears baby shampoo.^[3]

It’s hard to reconcile such betrayals with the company’s credo, formulated in 1943 and promoted as guiding the company’s ethics; “Caring for the world, one person at a time.” Who knew that Johnson & Johnson’s claims that their baby shampoo is as gentle to the eyes as pure water rests on their abuse of prisoners attempting to earn money to pay bail, or send home to their wives and children? I certainly didn’t when I used these products on my son, nor did I know that they contained formaldehyde, the chemical used to embalm his body after his death due to the use of  pharmaceutical drugs. My sister who bathed her babies with Johnson & Johnson products and who died three years ago from Leukemia had no idea that the baby shampoo she used contained dioxane, known in California and by the U.S. EPA as a “probable carcinogen” that can cause “hepatic and renal lesions, and demyelination and edema of the brain.”

On their website, J&J reassures consumers that Johnson & Johnson Consumer Companies, Inc., does not test products on animals. They don’t mention that their baby shampoo was tested in such a horrific way on human beings.

Johnson & Johnson, with their pastel-hued website and carefully cultured image as the champions of mother-baby bonding and gentle, natural products, has a special place in the hearts of mothers throughout the world  . . .  and an appalling history of deception and abuse.

Allen M. Hornblum, in his 1998 book Acres of Skin: Human Experiments at Holmesburg Prison, documented the longest known case of prison experimentation in the United States, in which a dermatologist conducted hundreds of experiments on prisoners for Johnson & Johnson, Dow Chemical and the U.S. Army.^[4]  The American Journal of Psychiatry and the Law chronicles the history of pharmaceutical company use of prisoners for biomedical research, stating that until the early 1970s

Approximately 90% of all pharmaceutical research was conducted on prisoners, who also were subjected to biochemical research ranging from testing diet drinks and simple detergents to studies involving dioxin and chemical warfare agents. From 1962 to 1966, for example, 33 pharmaceutical companies tested 153 experimental drugs at Holmesburg Prison in Philadelphia, including a Retin-A (tretinoin) study in which researchers did not seek informed consent and prisoners were not adequately treated for pain.

In the 70s, as the abuses perpetrated on prisoners became known, the US made a series of regulatory changes which effectively halted biomedical research on prisoners, but only that undertaken by government agencies. The rules did not apply to pharmaceutical companies, who have continued to experiment on incarcerated people despite clear evidence that true informed consent is virtually impossible to obtain in the prison environment. As Vera Hassner Sharav of the Alliance for Human Research Protection (AHRP) points out

“The history of U.S. prison research confirms abuse, not benefit. Prisoners were exposed to cancer-causing and radioactive chemicals at Holmesburg Prison in Pennsylvania between 1951 and 1974. Juvenile inmates at Stockton Prison in California were subjected to psychotropic drug tests in 1997 despite regulatory prohibitions. A federal investigation in 2000 documented gross violations in prison research conducted by the University of Texas at Galveston. Inmates should be off-limits except for noninvasive research aimed at improving prison conditions, such as finding ways to prevent staph infections.^[5]“

In 2007 In response to a request from the Office for Human Research Protections (OHRP), the Institute of Medicine (IOM) formed the Committee on Ethical Considerations for Protection of Prisoners Involved in Research, to address ethical considerations for protecting prisoners involved in research. The Committee reported that the critical question facing the Committee was whether current federal regulation is ethically sound and achieves the right balance between scientific knowledge and prisoner vulnerability. In their own words

“Our answer, after an exhaustive study, was an emphatic “no” . . . the Committee found that the federal system of human subject protection is deficient.^[6]“

They go on to say that

“The Committee was surprised and disappointed to find that there were no systematic data sources on the quantity and quality of prisoner research in the United States. Committee members searched the literature and determined there is a great deal of research involving prisoners taking place that appears to be largely unregulated.^[6]“

They report that the most glaring problem in current regulation of research on prisoners is that it covers only a handful of federal agencies. It does not cover private research agencies or pharmaceutical companies. The committee’s investigations found that most studies (66%) did not have approval by Institutional Review Boards.  Some states allowed biomedical research which had no therapeutic benefit to the prisoner participating in the study.  Only half of studies of involving prisoners with HIV/AIDS mentioned informed consent, and fewer than half of the states allowing research on prisoners had a procedure for reporting adverse reactions arising from prison research.

In congressional hearings in 1973, pharmaceutical industry officials openly admitted they were using prisoners for testing because they were cheaper than chimpanzees.^[7]  In a meeting with the IOM Committee in 2005, the AHRP pointed out the other key difference between chimpanzees and humans as research subjects, saying;

[Prisoners’] only single armor against being subjected to experimental abuse hangs on a single thread, on a single federal regulation in federally funded research only. Chimpanzees, by contrast, are protected by mandatory rules, oversight, and enforcement mechanisms since the Animal Welfare Act of 1966. The U.S. Department of Agriculture (USDA) must submit annual reports to Congress documenting the disposition of every chimp, dog, rabbit, and hamster. No one keeps track of how many human beings have died or been harmed in clinical research.^[5]”

Vera Hassner Sharav argues that

“The push for prison experiments is motivated by business priorities. The biotech and pharmaceutical industries are addressing the shortage of volunteers by dipping into a deep pool of captive subjects with limited rights, housed in inherently coercive environments. Prisoner research is about exploitation, profit and expediency, not about the benefit of prisoners.^[5]“

Despite their shameful history, a review of the US government trials database shows Johnson & Johnson subsidiary Janssen continue to test their drugs on prisoners. That the IOM recommended the opportunities to conduct research on prisoners be reinstated albeit with tighter ethical guidelines and that pharmaceutical companies have a history of ignoring regulation, is of serious concern.

J&J has some other skeletons in their closet that undermine their supposed commitment to safety, skeletons that relate particularly to babies and children and their parents. In 2010, when already overseeing the recall of more than 40 varieties of  medicines for infants and children manufactured by a J&J subsidiary, which resulted in 775 reports of children and infants who experienced an adverse reaction, including 37 deaths, the FDA was advised of a ‘phantom recall’ of another J&J drug.

A memo containing detailed instructions to contract workers to buy up Johnson & Johnson’s Motrin (ibuprofen) from stores – discovered because one of the contractors accidentally dropped an instruction sheet on the floor of a store – instructed contractors;

“You should simply ‘act’ like a regular customer while making these purchases.  There must be no mention of this being a recall of the product!^[8]“

Johnson & Johnson had found that Motrin had a manufacturing defect which the FDA later assessed as having the potential to cause adverse events, but decided not to inform the public through a product recall but to remove it from the shelves by stealth.

Motrin became the first of four FDA recalls of Johnson & Johnson products in 2010 including the recall of 136 million bottles of infant and children’s Tylenol, Benadryl and Zyrtec.  Darrell Issa, the ranking republican on a Congressional Committee investigating Johnson & Johnson, expressed his anger at the company, saying;

“It is a moral outrage for a company specifically marketing its products for children to allow a culture of neglect and irresponsibility to taint the medicines that parents and physicians trust to help children get well.^[9]“

J&J apologized to the public and swore to work hard to regain its trust.  Given that J&J issued a further recall of 200,000 bottles of Motrin Infant Drops contaminated with plastic particles in September 2013,  trust is still an issue.

As if contaminated infant pain drugs weren’t enough, parents of newborns have another reason for being skeptical of the value of J&J’s baby products after an increase in the frequency of positive urine drug screens for newborns in 2011 was found to be a result of J&J’s Head-to-Toe Foaming Baby Wash giving a false positive for THC, the active ingredient in marijuana.^[10]  The researchers state that screening for exposure to marijuana is common in infants of mothers who do not come in for prenatal care visits and that 10 to 40 percent of babies born in the hospital for whom they conduct analysis receive the test each month.^[12]  The research report notes,

“Baby wipes, gauze, cotton balls, diapers, and urine collection bags incubated with drug-free urine samples showed no reactivity with the THC screening assay. However, the addition of Head-to-Toe Foaming Baby Wash (Johnson & Johnson) showed a dose-dependent response “exceeding the threshold for a positive screening.^[13]“

They point out that the results of newborn drug screening have far-reaching impacts both in the health and legal domains, with positive results potentially triggering investigations by child welfare authorities and say they conducted their study to  protect families from being falsely accused.

Dr. John Spangler, an associate professor of family and community medicine at Wake Forest University School of Medicine in Winston-Salem, N.C., said in an email to ABC News,

“This has profound implications. Think about being a mother who knows she has never been exposed to illicit drugs. How does she fight against the supposed ‘objective’ lab test? ^[14]“

ABC reports that Spangler cited mothers who had been arrested based on tests of their babies, but insisted that they had never smoked marijuana.^[13]

But wait, there’s more. The US Department of Justice website details fraudulent and dishonest behavior by Johnson & Johnson which resulted in fines of $2.2 billion in 2013 for promoting their antipsychotic drug Risperidone for the elderly, children and the mentally ill despite the fact it wasn’t approved for those populations, despite the evidence it was harmful and despite repeated warnings from the FDA to stop. Attorney General Eric Holder accused J&J of jeopardising the health and safety of patients and damaging the public trust while Associate Attorney General Tony West accused them of putting profit over patients’ health.^[14]

Johnson & Johnson illegally promoted Risperdal for ADHD with disasterous results for many children. Little boys grew female breasts that lactated.  In September, 2012 the case of a young man called Aron Banks, who took Risperdal between the ages of 9 and 14 years old, at a time it was not approved for children, and had required surgery to remove excess breast tissue was the first to go to trial. Johnson & Johnson settled on the first day of trial for an undisclosed sum.  Hundreds of similar lawsuits await trial.

Researchers warn

“Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea. Given that the long-term effects of antipsychotic drug-induced hyperprolactinemia are not well documented, especially regarding osteopenia, infertility, growth, and pubertal delay, risperidone should be administered with caution to children and adolescents.[]”

What they don’t tell us about is the shame young men like Aron may have felt, the humiliation and bullying, the fear of school changing rooms, the avoidance of participation in sport and of relationships with girls, the fear of being different and the impact of all this on a young man’s sense of self worth, masculinity and social skills.

Never mind; Johnson & Johnson are feeling good about themselves, announcing worldwide sales for 2013 of $71.3 billion; led, they tell us, by the outstanding performance in their pharmaceutical business. When in the announcement they say they “touch the lives of over a billion people every day, throughout the world” they are probably not thinking of Aron and how they have affected his life. Or the 490 people harmed by Risperdal who have lawsuits pending against Johnson & Johnson.

The most recent J&J scandal involves the removal of formaldehyde and reduction in 1,4 dioxane in its baby shampoo in response to calls for a boycott of the product and claims that mounting evidence shows cumulative exposure can be dangerous. In May 2009, over 40 organizations representing 1.7 million parents, health care providers and environmental health advocates wrote to Johnson & Johnson with their concerns about the toxic chemicals found in the company’s baby products. They wrote again in September 2009 and the American Nurses Association and the Campaign for Safe Cosmetics met Johnson & Johnson executives several times between 2009 and 2011 to discuss the issues associated with the presence of formadehyde and dioxin in their baby products.^[15]

With no action forthcoming from the company, the Campaign for Safe Cosmetics, American Nurses Association, Physicians for Social Responsibility and many other health and parents’ groups wrote yet another letter to Johnson & Johnson asking the company to set a deadline of November 15, 2011 for the removal of formaldehyde releasing chemicals from baby products. Why has it taken so long for Johnson & Johnson to reformulate their product when the version sold in Denmark, Finland, Japan, the Netherlands, Norway, South Africa, Sweden and the U.K has never contained the chemical and thus the formula for formaldehyde-free baby shampoo must be available.  Why were babies on one side of the world exposed to embalming fluid and carcinogens in their shampoo and babies on the other side not? Why has it taken five years for Johnson & Johnson to address an issue first raised with them over four years ago?

Apparently, according to their own publicity, Johnson & Johnson have held themselves to the very highest standards for more than one hundred years. They are most closely associated, in the public’s mind, with the phrase ‘No more tears.’

The bottom line is that they are associated with more tears than most companies, and I will never buy a Johnson & Johnson product again.

 * * * * *

 

[1] Whelan, F. The Rise of Bioethics in 20^th Century America: The Holmesburg Prison Experiments in Context. History Honours Thesis, Fall 2012.

[2] Cotten, S.,  Duncan, D.,  Burch, E., Seashore, C., Hammett-Stabler, C.; Unexpected interference of baby wash products with a cannabinoid (THC) immunoassay. Clinical Biochemistry. June 2012, 45(9) 605–609

[3] Katie Thomas, The ‘No More Tears’ Shampoo, Now With No Formaldehyde. New York Times, January 15, 2014

[4] Hornblum, A.M.,  Acres of Skin: Human Experiments at Holmesburg Prison, Campaign for Safe Cosmetics, Routledge, 1988

[5] Vera Hassner Sharav, Should prisoners participate in medical research trials? Proto, Massachusetts General Hospital

[6] Institute of Medicine (US) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research; Gostin LO, Vanchieri C, Pope A, editors. Ethical Considerations for Research Involving Prisoners. Washington (DC): National Academies Press (US); 2007. 2, Today’s Prisoners: Changing Demographics, Health Issues, and the Current Research Environment.

[7] Mike Stobbe, Past Medical Testing on Humans Revealed,  Washington Post, February 27, 2011

[8] Mike Stobbe,  Parija Kavilanz, Johnson & Johnson’s drug problem Behind the ‘phantom recall’ of Motrin CNN Money, June 2, 2010

[9] Layton, L., Maker of children’s drugs accused of hiding Motrin recall from public. Washington Post. May 28, 2010

[10] Steven W. Cotten, Daniel L. Duncan, Elizabeth A. Burch, Carl J. Seashore, Catherine A. Hammett-Stabler; Unexpected Interference of Baby Wash Products with a Cannabinoid (THC) Immunoassay. Clinical Biochemistry.  June 2012, 45(9) 605–609

[11] Rachael Rettner, Strange Reason for Baby’s Positive Pot Test Found, Livescience, June 13, 2012

[12] Deborah Brauser Baby Wash Linked to False-Positive In Utero Marijuana Exposure, Medscape Medical News, June 22, 2012

[13] Kevin Dolak, Chemicals in Baby Shampoos Lead to False Marijuana Positives, ABC News, June 20, 2012

[14] Department of Justice Office of Public Affairs, Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations, November 4, 2013

[15] Campaign for Safe Cosmetics, Baby’s Tub Is Still Toxic, November 1, 2011