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Exchange of Views with Daniel R. Gerard, MS, RN

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December 15, 2005 Critical comments submitted by Daniel R. Gerard, MS, RN

First of all reviewing Dr. Al-Bayati is not the same as reviewing the actual coroner’s report from LA County.

Second the tragedy of this event is that this child did not have to die. Treatment with anti-viral medications during pregnancy has a high percentage of preventing HIV in fetus.

Third, testing after birth, combined with treatment and care by pediatricians skilled in treating HIV infected children, may have provided an opportunity to warn of PCP in this child. Treatment, especially when diagnosed early, is very efficient.

Christine Maggiore, while I am sure she is an intelligent woman, seems to ignore one fact. That since we first identified HIV, the death rate and long term survival rate with treatment has increased.

Those who forgo treatment, with the exception of a minute minority, die.

If Christine Maggiore were a scientist or physician, maybe her views would hold up to the light of day. She is neither. She speaks for a fringe minority, a minority devoid of realism.

I feel for Eliza Jane’s parents, but at the same time if they love their surviving child, they should have him tested and treated.

December 16, 2005 Response by David Crowe

I’m not sure that I understand your comment “reviewing Dr. Al-Bayati is not the same as reviewing the actual coroner’s report from LA County”. Dr. Al-Bayati did review the coroner’s report, and also the original hospital report. This was his job, to determine whether the conclusions that the coroner drew from the information available to him were warranted.

Regarding your assertion that “Treatment, especially when diagnosed early, is very efficient”, you do not appear to be very familiar with the literature about how dangerous these drugs are.

AZT (aka Retrovir, Zidovudine), the most commonly used such drug is known to cross the placenta. It’s also suspected as a carcinogen, mutagen and teratogen. This is not surprising because it is a DNA chain terminator, a thymidine analog.

Furthermore, you seem to be assuming that the cause of death was PCP (not an allergic reaction to amoxicillin). Do you not believe that it is possible for an HIV-positive child to die of something other than an HIV-related condition?

If EJ did die of something other than PCP, then HIV/AIDS testing or treatment would obviously have been superfluous, even accepting that it ever does have value.

Your claims that “since we first identified HIV, the death rate and long term survival rate with treatment has increased” is questionable.

Many things have changed over time. Originally there were a small number of people diagnosed with AIDS who were severely ill at the time. As of 1993 it became possible to diagnose people with AIDS who were not ill at all (based on positive HIV test and low CD4 cell count) and by 1997 almost 2/3 of new diagnoses were in this category.

You state that “Those who forgo treatment, with the exception of a minute minority, die”. Can you explain how Christine is still healthy, without AIDS drugs, more than a decade after her first positive test? I know several other people with similar experiences.

Furthermore, you believe that your patients are all taking the drugs, but my experience with many parents who believe that these drugs are toxic (often by observing their children vomit, wake up screaming in the night, have continuous diarrhea and so on) will simply stop giving them to their children, but very rarely tell medical professionals because of the fear of legal action.

You should read “The Silent World of Doctor and Patient” by Jay Katz, a Yale medical/legal scholar. It explains why this one-way communication exists and how unhealthy it is for both medical professionals and their patients.

Your statement that “If Christine Maggiore were a scientist or physician, maybe her views would hold up to the light of day” is a status-based argument. It is not the letters after your name that count, it is having a skeptical outlook on claims, and actually reading the literature that counts. Many non-scientists and non-physicians have spent a considerable time reading the published literature.

Many doctors, on the other hand, get most of their information from drug company literature (this is documented) which obviously attempts to minimize the danger of these drugs and exaggerate their effectiveness.

Finally, you claim that their surviving child, Charlie, should be tested and treated.

Charlie has been tested. He is negative. Can you explain this?

Christine’s 10-year partner and husband Robin is also negative. Can you explain this?

Can you guarantee that Christine would still be alive now if she had started AIDS drugs in 1992, or even if she had waited for protease inhibitors around 1996?

References on AIDS Drug Use in Children

“In reviewing the frequency of birth defects in this population [of HIV+ women taking AZT during pregnancy] we noted eight birth defects (10%) out of 80 live births [and 8 spontaneous fetal losses, for a total of 17% abnormal pregnancies]”

Kumar RM et al. Zidovudine Use in Pregnancy: A Report on 104 Cases and the Occurrence of Birth Defects. J Acquir Immune Defic Syndr. 1994 Oct; 7(10): 1034-9.

”Conclusions: In HIV-infected pregnant women treated with two RTI [nucleoside analogs, of which AZT was the most common] with or without protease inhibitors, one or more adverse events occurred in 29 out of 37 women and in 14 out of 30 babies.”

Lorenzi P et al. Antiretroviral therapies in pregnancy: maternal fetal and neonatal effects. AIDS. 1998; 12: F241-247.

”Comparison of HIV-1-infected children whose mothers were treated with ZDV [AZT] with children whose mothers were not treated showed that the former group had a [1.8 times] higher probability of developing severe disease or severe immune suppression [2.4 times higher risk] and a lower survival (72.2% versus 81.0%).”

The Italian Register for HIV Infection in Children. Rapid disease progression in HIV-1 perinatally infected children born to mothers receiving zidovudine monotherapy during pregnancy. AIDS. 1999 May 28; 13: 927-33.

”Eight children with mitochondrial dysfunction were found...the first patient presented with visual impairment...[and] died aged 13 months because of respiratory and cardiac-rhythm disorders...The second patient, from age 4 months until until death at 11 months, had refractory epilepsy and deterioration of cognitive and psychomotor abilities...At age 8 months...patient three had a seizure...At age 4 years, the child’s cardiac function was normal, but moderate muscular deficit persisted...In the fourth patient...between ages 14 and 27 months, the child had four episodes of febrile seizures...From age 7 months until 15 months, patient five had repeated age 16 months...large necrotic lesions of the [brain]...At age 3-1/2 years the child had severe sequelae and microcephaly [abnormally small head]. Patient 6 was symptom-free until age 14 months, but persistent biochemical abnormalities were seen on standard follow-up...Patient 7 was symptom-free until age 4 months, at which time he became hypotonic [low muscle tone] [and stopped breathing]...The eighth child was symptom-free. Persistent hepatic and pancreatic abnormalities were seen from birth...At age 20 months, biological abnormalities persisted...electroretinography...was abnormal, and cerebral NMR imaging...showed abnormalities of the periventricular white matter...No child was infected with HIV-1 [but because their mothers were HIV-positive] all children were treated after birth with zidovudine [AZT] alone or with zidovudine and lamivudine [also a nucleoside analog]. Treatment continued for 6 weeks in four children and was stopped prematurely because of haematological or biochemical intolerance in four children...The observation of several cases [of mitochondrial abnormalities] in a population of about 1700 exposed children [as compared with 1/5,000 to 1/20,000 in normal populations] strongly suggests an acquired mitochondrial dysfunction...Pregnant women should be informed of the potential effects associated with these treatments during pregnancy.”

Blanche S et al. Persistent mitochondrial dysfunction and perinatal exposure to antiretroviral nucleoside analogues. Lancet. 1999 Sep 25; 354: 1084-9.

“In a multicenter observational cohort study of 325 HIV-infected children born during 1986-1997, clinical progression was compared among infected children exposed or unexposed to Zdv [AZT] during prenatal and perinatal periods. Zdv exposure was associated with 1.8-fold (95% confidence interval, 1.02-3.11) increased risk of progressing to AIDS or death after adjusting for year of birth, maternal CD4 cell count, maternal AIDS diagnosis, and subsequent antiretroviral therapy of the child. Mean log10 viral copies at 712 weeks were higher among Zdv-exposed children (P = .004).”

Kuhn L et al. Disease Progression and Early Viral Dynamics in Human Immunodeficiency Virus Infected Children Exposed to Zidovudine during Prenatal and Perinatal Periods. J Infect Dis. 2000 Jul; 182(1): 104-11.

“After adjusting for prematurity and maternal clinical characteristics, RPD [rapid disease progression] was three times more likely to occur in infants born to [mothers] treated [with AZT] compared with findings in untreated mothers (RR=2.8; p = .021).”

de Souza RS et al. Effect of prenatal zidovudine on disease progression in perinatally HIV-1-infected infants. J Acquir Immune Defic Syndr. 2000 Jun 1; 24(2): 154-161.

“Children of study women who were prescribed ZDV [AZT] had increased adjusted odds of any anomaly (adjusted odds ratio [OR], 1.55; 95% CI, 1.01-2.29) [i.e. more than one-and-one-half times the risk of a birth anomaly than the HIV+ population being studied in general]...The prevalence of major anomalies in the full cohort based on definition 1 was significantly higher than that observed in the general New York State population...the SMR [Standardized Morbidity Ratio] adjusted for race, gender, and location suggests that the risk of a major anomaly in the study cohort was 2.79 times greater than the general population...the lack of data on potential adverse effects of this therapy is still a concern...we compared anomaly rates of subgroups defined by ZDV exposure history within the cohort of HIV-infected mothers. Babies whose mothers had ZDV exposure during pregnancy had a greater incidence of major malformations than those whose mothers did not.”

Newschaffer CJ et al. Prenatal Zidovudine Use and Congenital Anomalies in a Medicaid Population. J Acquir Immune Defic Syndr. 2000 Jul 1; 24(3): 249-256.

“Other factors associated with lower cumulative survival included suppressed CD4 cell counts, a history of zidovudine [AZT] therapy [Table 1 shows that children who had taken AZT had a 37.5% risk of death over the study period versus 22.8% for those who had not. There was a 97% probability that this increase was not due to chance], and Pneumocystis carinii pneumonia diagnosed before the initial echocardiogram.” “Other factors associated with lower cumulative survival included suppressed CD4 cell counts, a history of zidovudine therapy [Table 1 shows that children who had taken AZT had a 37.5% risk of death over the study period versus 22.8% for those who had not. There was a 97% probability that this increase was not due to chance], and Pneumocystis carinii pneumonia diagnosed before the initial echocardiogram.”

Lipshultz SE et al. Cardiac Dysfunction and Mortality in HIV-Infected Children. Circulation. 2000 Sep 26; 102(13): 1542-8.

“A total of 397 adverse events, 180 biological (ie, involving hematologic or blood chemistry alterations) and 217 clinical in nature, were reported among 238 of the 452 children in the lamivudine[3TC]- zidovudine[AZT] cohort. Altogether, 151 hematologic adverse events, defined as moderate to severe according to the age-adjusted ACTG classification,17 occurred during exposure to study drugs. These mostly consisted of neutropenia (81 cases) or anemia (68 cases), leading to blood transfusion because of clinical symptoms in 9 infants (5 had mild symptoms (pallor or tachycardia [abnormally rapid heartbeat]) and 4 had severe symptoms (cardiac insufficiency or dyspnea)) and to premature treatment discontinuation for 19 children. Of the children with hematologic...Liver abnormalities without proven cause were recorded in 6 children ...Of the 217 clinical adverse events reported among children, most were [judged to be] due to a known cause unrelated to study drugs [but without a true control, this is impossible to say with assurance]... 16 children (4%) had major birth defects, including 4 cardiac malformation cases, 4 cases of polydactyly, 3 talipes cases, and 1 case each of congenital diaphragmatic hernia, hydronephrosis, imperforate anus, genu recurvatum with a suburethral cyst, and hypospadia. 1 child each had Down syndrome, Ito nevus, and sickle cell anemia...Neurologic signs/symptoms were reported in 12 children who did not have HIV infection and had no other known infectious or genetic disease.”

Mandelbrot L et al. Lamivudine-Zidovudine Combination for Prevention of Maternal-Infant Transmission of HIV-1. JAMA. 2001 Apr 25; 285(16): 2083-93.

“The study cohort included 92 HIV-1-infected and 439 uninfected children...FTT [failure to thrive among children of HIV-positive women] was associated with a history of pneumonia, maternal use of cocaine, crack or heroin during pregnancy, infant CD4+ T-cell count and any antiretroviral therapy by 3 months of age...Antiretroviral therapy (nonprotease inhibitor) was independently associated with FTT in our cohort...ZDV [AZT], in particular, alters mitochondrial metabolism and may have direct nutritional effects”

Miller TL et al. Maternal and infant factors associated with failure to thrive in children with vertically transmitted Human Immunodeficiency Virus-1 infection: the prospective, P2C2 Human Immunodeficiency Virus Multicenter study. Pediatrics. 2001 Dec; 108(6): 1287-96.

“[Of 195 mother-infant pairs] 9 children (4.6%) with congenital abnormalities were reported. Compared with the 148 infants not exposed to ART or folate antagonists [including PCP therapy with cotrimoxazole or pyrimethamine] during the first trimester, first trimester exposure to both therapies (n=13 [23%]) was associated with a 7-fold increased risk of congenital abnormalities. No congenital abnormalities were observed in the 34 infants exposed to either ART alone or folate antagonists alone during the first trimester...severe immunosuppression [very low CD4 cell counts] has so far not been associted with fetal abnormalities and is unlikely to be a confounder”

Jungmann EM et al. Is first trimester exposure to the combination of antiretroviral therapy and folate antagonists a risk factor for congenital abnormalities? Sex Transm Infect. 2001 Dec; 77(6): 441-3.

“149 (78%) of 192 children experienced moderate or worse toxicity while receiving initial therapy [in this trial of various combinations of 3 or 4 AIDS drugs], and 44 (23%) of 192 experienced severe or worse toxicity...The most commonly observed adverse events were skin rash (53(28%)); nausea/vomiting (44(23%)); and temperature >= 38.5C (40(21%))...Administration of initial randomized study treatments was permanently discontinued for children with (1) an HIV RNA copy number > 10,000 copies/ml (32(17%)); (2) toxicity of medication intolerance (13(7%)); or (3) other reasons, including poor adherence to the study regimen and parental request for withdrawal of the patient from the study (29(15%))”

Krogstad P et al. Nucleoside-analogue reverse-transcriptase inhibitors plus nevirapine, nelfinavir, or ritonavir for pretreated children infected with human immunodeficiency virus type 1. Clin Infect Dis. 2002 Apr 1; 34(7): 991-1001.

“Drugs typically administered to prevent the transmission of human immunodeficiency virus (HIV) accounted for 25% of all the reported adverse events through maternal exposure [in the United States]. HIV drugs with >10 case reports each were zidovudine [AZT] (177), lamivudine [3TC] (57), nelfinavir (56), and nevirapine (44). Without data about how frequently these drugs were prescribed to prevent HIV transmission, it is not possible to tell whether zidovudine was more toxic in this therapeutic setting than similar drugs...A wide spectrum of adverse events were associated with the HIV-related drugs, including 110 cases (35%) with an outcome of congenital defect or permanent disability, 103 (34%) cases involving initial or prolonged hospitalization or a life-threatening event, and 23 (7%) with death as the reported outcome. [Note that it is estimated that only 1% to 10% of adverse drug reactions are reported]”

Moore TJ et al. Reported adverse drug events in infants and children under 2 years of age. Pediatrics. 2002 Nov; 110(5): e53.