Archive for August, 2008

Judicial Watch reports on the Gardasil public health experiment

Monday, August 25th, 2008

Based on records obtained under a May 2007 Freedom of Information Act (FOIA) request, Judicial Watch has summarized the approval process, side effects, safety concerns, and marketing practices related to the human papillomavirus (HPV) vaccine Gardasil. It calls these a “large-scale public health experiment.”

One of the most startling findings is 78 cases of outbreaks of warts following the vaccine in women already infected without knowing it. Besides genital warts, some patients experienced massive outbreaks on the face, hands, or feet, sometimes caused by strains not included in the vaccine.

Additionally, the vaccine could increase the incidence of CIN 2/3 (cervical endothelial neoplasia in moderate stage) in women who had persistent infection with “vaccine-relevant” HPV strains at baseline. A chart in a report of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) showed an efficacy rate of –44.6% (that’s a minus sign) in subjects already exposed to “relevant HPV types.”

On June 25, 2008, the FDA denied Merck’s application to expand marketing of Gardasil to women aged 27 through 45. The FDA refused Judicial Watch’s request for a copy of the letter to Merck, stating that it may be available under FOIA.

Merck also failed to win approval to expand the vaccine to more strains and has reportedly dropped plans to do so.

Most tests with Gardasil were done against an adjuvant-containing “placebo,” rather than a nonreactive saline base, possibly making the vaccine seem safer than it actually is.

In its report to the FDA, Merck noted that “it is not known whether Gardasil can cause fetal harm when administered to a pregnant woman.” It reported that 27% of pregnant women experienced an adverse reaction upon receiving the vaccine, and the Vaccine Adverse Event Reporting System (VAERS) contains 45 cases of spontaneous abortion following Gardasil.

A pre-condition for fast-tracking Gardasil was a requirement for a safety surveillance study, which will not be complete until June, 2009. Nonetheless, intensive marketing continues.

A total of 8,864 VAERS reports have been filed, including 38 of Guillain-Barre syndrome and 18 deaths, 11 occurring within one week of receiving the vaccine. Association, of course, does not prove causality.

The entire Judicial Report is available.

Mandating HPV vaccine is a matter of the public good vs. private rights, states Alexandra M. Stewart, J.D., who worked under contract from Merck with the George Washington University Medical Center to study Medicaid coverage for HPV vaccine. The intimate mode of transmission is “a distinction without a meaningful difference”; therefore, legal precedents justifying mandates should apply to Gardasil, she writes (N Engl J Med 2007;356:1998-1999).

In an article that appeared in MedScape on July 26, and was quickly taken off the website, Diane Harper, M.D., a principal chief investigator in clinical HPV trials, was quoted as saying, “The side effects that have been reported are real and they cannot be brushed aside.” She suggested that physicians not vaccinate patients with personal or family histories of the more serious complications, which have included neurologic disorders, thromboembolism, and autoimmune conditions.

“The cause of recent complications remains a mystery and it is difficult to know whether they are linked to vaccines,” the article stated.

Two physicians, a cardiologist and a rheumatologist, say they regret their decision to immunize their 17-year-old daughter and will not encourage his younger daughters to receive the vaccine. After being vaccinated, their eldest went from being a healthy athlete to a chronically ill patient. He worries that other girls may be struggling with immune damage, feeling achy and unwell, but going undiagnosed and unreported.

Gynecologist Christiane Northrup, M.D., appearing on the Oprah Winfrey Show, told viewers that she wouldn’t advocate vaccinating her daughters, and that medical dollars were better spent elsewhere.

The FDA and CDC issued a joint statement reassuring the public and physicians of the vaccine’s safety.

MedScape was accused of “germ theory denialism” (apparently for suggesting that it might be fruitful to investigate how most patients successfully fight off HPV) and “antivaccination myths.” It was also criticized for having the “chutzpah” to run a poll on how physicians were reacting to the reports about adverse events and the FDA/CDC advisory, and the poll has apparently been pulled also.

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Should the “dead donor” rule be rescinded?

Saturday, August 16th, 2008

At Children’s Hospital in Denver, three babies recently had successful heart transplants from neurologically damaged donors who were not brain dead. The donors were removed from the ventilator in the operating suite, and their hearts were harvested within minutes after asystole.

In 2007, there were 793 cardiac-death donors (“non-heart-beating donors”), about 10 percent of all deceased donors, according to the United Network for Organ Sharing. Most recipients were adults who received a kidney or liver (Stephanie Nano, Associated Press 8/13/08).

Death statutes require the irreversible cessation of circulation and respiration or the irreversible cessation of brain functions. In the three controversial Denver cases, cessation of heartbeat was not irreversible; the hearts started up again after transplantation. One baby’s heart had been stopped for only 75 seconds. The only reason the donor could not have been resuscitated was the “do not resuscitate” order. It is not known how long a heart has to be stopped before “autoresuscitation” is impossible (Bernat JL. N Engl J Med 2008;359:670-673).

“Donor care” included placement of femoral venous and arterial sheaths, using local anesthesia; two heparin boluses of 100 U/kg and later 300 U/kg; sedation and analgesia considered appropriate for withdrawal of life support (fentanyl at a mean dose of 4 µg/kg and lorazepam at a mean dose of 0.1 mg/kg); and extubation.

Analgesic and sedating drug doses were stated to be lower than those used in infants who could not be considered for donation, and the heparin dose was within the range used for cardiopulmonary bypass (Bouck MM, et al. N Engl J Med 2008;359:709-714).

(The apnea test for brain death requires that the patient remain intubated, receive oxygen by continuous positive airway pressure to maintain saturation and an arterial pO2 >55 mm Hg, and be free of drugs that cause respiratory suppression.)

Boucek et al. note that using potential donors who die of cardiorespiratory causes could increase the donation rate by 70 percent (ibid.).

New England Journal of Medicine editorialists write that there is an “urgent need for more infant donors,” and that “meeting this need while being mindful of the ethical considerations has been challenging and complex” (Curfman GD, et al. N Engl J Med 2008:359:745-750). A free video roundtable on the ethical issues is available at www.nejm.org.

Bernat asks: “To what extent should society permit manipulation of an organ donor or alteration of the determination of human death for the good of organ recipients?”

Truog and Miller point out the difficulties posed by changing the definition of death to mean something other than “cold, blue, and stiff.” Many brain-dead patients retain neurologic functions such as the regulated secretion of hypothalmic hormones. If permanent unconsciousness is the justification for taking the organs, the same rationale should apply to patients in a persistent vegetative state.

“The reason it is ethical [to take the organs] cannot be that we are convinced they are really dead,” they write. “Irreversibility” means a “choice not to reverse.” Thus, instead of making unsupportable revisions of the definition of death, we should do away with the “dead donor” rule. At this point, it “has greater potential to undermine trust in the transplantation enterprise than to preserve it.” Instead, we should rely on “valid consent by the patient or surrogate” in order to “maximize the number and quality of organs available to those in need” (Truog RD, Miller FG. N Engl J Med 2008:359:674-675).

Some might consider Truog, and Miller to be “brain death deniers,” and argue against the right to choice of “criteria of death.” Offering “futile treatment” to a brain-dead patient to please the family might conflict with or undermine the “regulative ideals” of medicine. Accommodation to cross-cultural conflicts “has limits when it comes to real costs to others and society,” write Applbaum et al. Specifically, the definition of death is “not a matter of individual choice controlled by an advance directive or by medical surrogates” (Applbaum AI, et al. JAMA 2008;299:2188-2193).

It appears that, according to these views in prestigious medical journals, rights and ethical principles emanate from “society,” and can be changed by the accepted authorities in case of “need.”

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Government funding breeds conformity, says surgery professor

Sunday, August 10th, 2008

If you want government funding, there are certain ideas that you dare not question, stated Donald W. Miller, M.D., University of Washington professor of surgery, a member of AAPS.

Miller’s views are similar to those expressed in 2005 by another UW professor, Gerald Pollack, whose work on muscle contraction has challenged the reigning view in his field. Pollock said that science has become a “culture of believers,” The rule is “just keep it safe and get your funding.”

Pollack noted that breakthroughs in science were fairly common 50 years ago, citing Linus Pauling in molecular biology, Jonas Salk in vaccines, Richard Feynman in physics, and James Watson and Francis Crick in the study of DNA. “Where are the heroes of the past 30 years?”

He believes that Einstein’s challenge of orthodoxy would probably fail in today’s grant system. Granting committees demand that a scientist predict what he will be able to accomplish in year one, year two, etc. This amounts to “an implicit admission that no breakthroughs are to be anticipated.”

If science is likened to a skeleton, the grant system sets out to pay a multitude of scientists to add a tiny bit of flesh. But what if the skeleton itself is misdesigned? In the past, science was recognized to progress by overthrowing the “dominant paradigm.” Today, defenders of the dominant paradigm are probably sitting on the grants committee.

Today’s orthodoxy holds, according to Miller, that global warming is caused by humans, AIDS is caused by the human immunodeficiency virus, heart disease is caused by saturated fats, and cancer is caused by mutations. It also holds that radiation, cigarette smoke, and other toxins are dangerous in proportion to their strength, no matter how small the dose. If you want to test a contrary belief, you won’t get funded.

Miller predicts that at some point a major belief like one of these will come tumbling down. “And when it’s acknowledged, a lot of other science will be called into question” (Bruce Ramsey, Seattle Times 3/19/08).

Dr. Miller will speak at the AAPS annual meeting in Phoenix, Sep 11-13.

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Sex-selective abortions punished in India; coming to America

Monday, August 4th, 2008

On June 19, a physician caught in the act of performing a sex-selection abortion was arrested in a town near New Delhi and remanded into judicial custody for 14 days, along with the woman’s husband. They were charged with violating the Pre-Natal Diagnostic Techniques and Medical Termination of Pregnancy Acts.

Because of frequent female infanticide and selective abortion of girls, the birth ratio was 927 girls born for every 1,000 boys in 2001, down from 962:1,000 in 1991. The severe shortage of brides in the Haryana region has resulted in a black market in women from other regions who are brought in and sold into marriage, according to a Meri News report.

Prime Minister Manmohan Singh called sex-selection abortions a “national shame.” He called such abortions “inhuman, uncivilized and reprehensible” (LifeNews.com 6/20/08).

As many as 200 million girls may have been killed worldwide in this way, mostly in Muslim and Asian countries. The rate is increasing because of ultrasound technology that permits sex identification around 18 weeks.

Using data from the U.S. 2000 census, researchers have noticed a male sex bias in U.S.-born children of Chinese, Korean, and Asian Indian parents. The effect of birth order is striking. There is a normal sex ratio, 106 girls to 100 boys, for first births. If the first birth is a son, the sex ratio of second children is also normal. But if the first child is a girl, the
second child tends to be a boy. And if the first two are girls, the third is 50% more likely to be a boy.

Authors Douglas Almond and Lena Edlund conclude that sex-selection abortion was being practiced in America as early as a decade ago.

According to a Zogby/USA today poll, 86% of Americans favor banning this practice, which is seen by many as the ultimate form of sex discrimination. Every year that he was in the U.S. Senate, Jesse Helms introduced a bill providing that “it shall be illegal to perform an abortion for the sole purpose of sex selection” (Population Research Institute Weekly Briefing 4/15/08).

The American College of Obstetrics and Gynecology (ACOG) states that “helping patients to choose the sex of their offspring to avoid serious sex-linked genetic disorders is considered ethical for doctors, but participating in sex selection for personal and family reasons, such as family balancing, is not.”

Since, however, it would be unethical to withhold medical information, such as the sex of the fetus, from patients who request it, it “may be impossible to avoid unwitting participation in sex selection.”

ACOG reassures physicians that “they are not obligated to perform an abortion, or other medical procedure, to select fetal sex” [emphasis added], according to a Feb 1, 2007, news release.

The ACOG Committee on Ethics Opinon No. 360, February 2007, is silent on the issue of whether physicians ought to refer patients to other providers who do not have qualms of conscience about such abortions.

A controversial later opinion, No. 385, issued November 2007, entitled “The Limits of Conscientious Refusal in Reproductive Medicine,” states that “conscientious refusals should be limited if they constitute an imposition of religious or moral beliefs on patients, negatively affect a patient’s health, are based on scientific misinformation, or create or reinforce racial or socioeconomic inequalities.” Pro-life physicians, it asserts, should not practice in “resource-poor areas,” but rather “in proximity to individuals who do not share their views.”

Parenthetically, this opinion is being reconsidered because of concerns that pro-life physicians could be decertified for “violation of ACOG rules and/or ethics principles,” say for failure to assure timely access to abortion or emergency contraception (AM News 4/14/08).

Trying to adhere to ACOG directives could create dilemmas. Sex-selection abortions would be unethical if they reflect the belief that males are “inherently more valuable than females” and thus violate the “ethical principle of equality between the sexes,” or perhaps because “the very idea of preferring a child of a particular sex may be interpreted as condoning sexist values and, hence create a climate in which sex discrimination can more easily flourish.” Yet, “it is often impossible to ascertain patients’ true motives for requesting sex-selection procedures.” Perhaps there are “financial” or “cultural” reasons that are not “personal and family reasons.” In any event, the committee concluded that the position of never participating in sex selection was “too restrictive.” And of course there is always the possibility that a woman also has a reason for abortion that is not related to sex selection.

Sex-selection abortion could create a major challenge for the hierarchy of ACOG values and “core” elements of the practice of medicine. According to Committee Opinion No. 385, these include patient autonomy; “maximum accommodation” to “authentic claims” of conscience; distributive justice; sexual equality; and safe, timely, and financially feasible access to abortion.

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