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Living in the Biotech Century

News, Resources, and Commentary

March 17, 2005

Continuing to assess the downside of Ritalin…

Study Shows Methylphenidate Linked to Chromosomal Changes

“In a small but startling preliminary new study, Texas researchers have found that after just three months, every one of a dozen children treated for attention deficit/hyperactivity disorder (ADHD) with the drug methylphenidate experienced a threefold increase in levels of chromosome abnormalities—occurrences associated with increased risks of cancer and other adverse health effects.

“The researchers say that to their knowledge this is the first study addressing the potential chromosome-breaking effects associated with treatment of children with methylphenidate, the generic name for a group of drugs that includes Ritalin, Concerta, Metadate CD and others.

“Methylphenidate is the most widely prescribed of a class of amphetamine-like drugs used to treat ADHD, with more than 10 million prescriptions written for it in 1996 alone. Between 1991 and 1999, United States sales of methylphenidate increased more than 500 percent.

“Researchers at The University of Texas M.D. Anderson Cancer Center in Houston and the University of Texas Medical Branch at Galveston (UTMB) reported their detection of the chromosome abnormalities in the journal Cancer Letters. Their peer-reviewed paper is to be published several months hence, but the journal editors have made it available online in the journal’s ‘articles in press’ section….”

Medical News Today – February 28, 2005

An abstract of the paper, “Cytogenetic effects in children treated with methylphenidate,” is available at the website of ScienceDirect, the publishers of Cancer Letters. The complete paper is available to non-subscribers for a fee.

For an excellent overview and analysis of the dramatic increase in the use of Ritalin and other psychiatric drugs to medicate American children, see Mary Eberstadt’s essay, “Why Ritalin Rules,” in Policy Review (April & May 1999, No. 94).

“What the hell happened?  Why am I not dead?”

Again with Feeling, the Pills Didn’t Kill

by David Reinhard

“Oregon’s dirty little secret is getting out—finally and just in time for the Supreme Court to contemplate the regulatory and pharmacological netherworld our assisted-suicide law has created. Our dirty little secret: The pills used in Oregon’s assisted-suicide experiment don’t always kill.

“If that has a familiar ring it’s because critics of the state’s approach to assisted suicide had warned that the drugs wouldn’t always lead to the swift, sweet or sure death that assisted suicide’s promoters promised. For their pains, critics were called liars, but last week Oregonians learned that one terminally ill man awoke nearly three days after he took his kill-pill potion. ‘What the hell happened?’ Estacada’s David E. Prueitt asked his wife upon waking up. ‘Why am I not dead?’

“Excellent questions. Critics provided answers years ago, and last week assisted-suicide fans finally had to admit a truth they once deemed a lie. Said Barbara Coombs Lee, co-president of Compassion & Choices: ‘He just didn’t die.’

“Assisted-suicide supporters, and even some non-supporters, hasten to note that this is the first problem in 171 cases. But this betrays a ‘hear-no-evil, speak-no-evil, see-no-evil’ approach to our experiment. In fact, the problems with the assisted-suicide law—its reliance on drugs, its sham safeguards and feckless reporting regime—were apparent before last week’s news….”

The Oregonian – Thursday, March 10, 2005

Using genetics to help prescribe drugs…

Genetic Tests Could Prevent Drug Reactions

DNA analysis can identify potential health problems, experts say

“For most of her life, Eileen Marshall’s trips to the dentist offered the prospect of sweating, itching and a racing heart.

“Her affliction wasn’t a case of nerves before the drill. It was a genetic inability to process Novocain, something she learned last summer when she took a DNA test offered by Seattle-based Genelex Corp.

“‘I’ve never really taken medications, but when I’ve had to take little amounts, like at the dentist, I’ve always had adverse reactions,’ the 54-year-old Olympia resident said. ‘I just figured that this is what people feel when they get Novocain.’

“Medical experts say tests like the one Marshall took offer hope for people whose bodies have trouble processing certain drugs. In theory, such tests might help prevent some of the 100,000 deaths and the more than 2 million serious drug reactions in the United States every year—all the more significant given recent findings that popular pain pills may be associated with an increased risk of heart problems….”

The Associated Press/MSNBC.com – January 25, 2005

The advent of “do-it-yourself” genetic testing…

DNA Testing Goes DIY

“Commercials hawking prescription drugs directly to consumers have driven doctors crazy for years. Now comes a new kind of medical marketing that is already troubling some medical professionals: at-home genetic testing.

“An increasing number of online startups are marketing tests that can show predisposition to any number of maladies, from breast cancer to blood clotting. They are exploiting the blizzard of genetic discoveries reported almost daily since scientists published the complete map of all human genes five years ago.

“The tests are cheap, easy to administer, often just a cotton swab inside the cheek, and the results are available online, cutting out the visit to the doctor’s office.

“Plus, the companies note, the test results aren’t usually jotted down on official medical histories, which keeps sensitive information away from insurance companies….

“The company currently offers genetic testing, with a la carte prices ranging from $199 to $380, for a predisposition to cystic fibrosis, blood clotting, iron overload and a heightened risk for lung and liver diseases. Testing positive can help customers make lifestyle changes to prevent the onset of disease, the company says.

“This week, in a small but dramatic move validating the popularity of the online approach, DNA Direct will begin offering two popular breast cancer tests created and conducted by Myriad Genetics, the most visible player in the field of ‘predictive medicine.’

“DNA Direct’s breast cancer testing plans are modest. Initially, it will offer two of Myriad’s less-complicated tests, which screen for only a few mutations on the key genes. DNA Direct expects the tests to cost roughly $300 each….

“Until DNA Direct came along, Myriad made the breast cancer test available only to patients who visited a doctor’s office or a cancer clinic….

“Still, as the popularity of at-home genetic tests soars, so do questions about whether they will be correctly interpreted. Skeptics fret that the online companies don’t have the expertise to properly explain the often complicated results….”

Wired News/Associated Press – March 7, 2005

Even though it’s a non-binding declaration, it is a major victory for cloning opponents…

General Assembly Adopts United Nations Declaration on Human Coning by Vote of 84-34-37

“The General Assembly this morning adopted the United Nations Declaration on Human Cloning, by which Member States were called on to adopt all measures necessary to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life. 

“Acting on the recommendation of the Sixth Committee (Legal)…the Assembly adopted the text by a vote of 84 in favour to 34 against, with 37 abstentions. 

“By further terms of the Declaration, Member States were also called on to protect adequately human life in the application of life sciences; to prohibit the application of genetic engineering techniques that may be contrary to human dignity; to prevent the exploitation of women in the application of life sciences; and to adopt and implement national legislation in that connection….”

The United Nations Press Release – March 8, 2005

When human tissue becomes a market commodity…

Cloning Sparks Concern Over Egg Donors

by Paul Elias

“Of all the questions about California’s ambitious plans to publicly finance human cloning projects for medical research, one of the thorniest may be how scientists plan to gather the thousands of eggs they’ll need from women.

“It’s an ethical dilemma that has made unlikely allies of Christian groups—who believe cloning immorally creates and destroys life in the name of science—and women’s rights activists who fear that poor women will be exploited by commercial interests willing to pay thousands of dollars for human eggs produced by fertility drugs.

“The issue is not abstract. A small, nonprofit lab outside Boston has been quietly paying a handful of women for the last four years to take hormone injections to ‘superovulate’ several eggs at once and donate them for research.

“The Bedford Stem Cell Research Foundation has paid about 20 women about $4,000 each plus expenses to take fertility hormones. It is the only U.S. organization known to be actively collecting eggs for research purposes….”

NYPost.com – March 10, 2005

A warning concerning the risk to women who donate eggs for stem cell and cloning research…

An Open Letter from Suzanne Parisian, MD

“To whom it may concern:

“I am a former Chief Medical Officer of the Food and Drug Administration (FDA), as well as physician, Board Certified Pathologist, past researcher in genetics and developmental biology, author of FDA Inside and Out, and President of Medical Device Assistance, Inc., a regulatory and clinical consulting firm. I personally have been involved in drug, biotechnology and device human clinical trials and am familiar with United States requirements for ethical biomedical conduct. I write this memo for scientists, physicians, legislators, press, and public health advocates who have an interest in SCNT [cloning] research. I strongly urge that sound ethical and medical practices are adopted regarding the manner in which eggs will be extracted from healthy women donors. Important facts for you to consider:

1. Although it is common practice in IVF facilities to extract eggs as part of infertility treatment, many of the drugs used during these procedures have not been adequately studied for long term safety, nor do some of these drugs have FDA approval for these specific indications. This is not widely understood and has led to significant misunderstanding about the risks involved for women who donate eggs, whether for reproductive purposes or for SCNT [cloning] research….

    

2. The long term health risks for a woman receiving IVF drugs for egg retrieval are unknown.

“A woman undergoing IVF stimulation today to conceive a child has accepted that there are ‘unknown’ long term health risks to her body from the stimulation drugs but accepts the risks in terms of a potential benefit to conceive a child. The risk versus benefit calculation for a healthy woman providing her eggs for stem cell research is not the same….

“Risks of the egg retrieval procedure, although rare, include death, respiratory or cardiac arrest, brain damage, paraplegia, paralysis, loss of function of a limb or organ, hemorrhage, allergic reaction, and infection. Bleeding or other injuries, which occur during retrieval, may require an invasive surgical procedure to correct and could affect future fertility.

“Regarding the unknown long-term risks, studies to date have not ruled out a possible link between stimulation drugs and an increased risk of ovarian cancer. All stimulation drugs are Pregnancy X—which means they are contraindicated for use in women that are pregnant due to a lack of information regarding the safety of these drugs during pregnancy….

“In conclusion, there is an unfortunate and false assumption of the public, legislators, press and physicians that all current IVF stimulation drugs have been scientifically recognized as ‘safe’ by the FDA and suitable for use in healthy women for multiple egg extraction. That simply and sadly is not correct….”

Thank you,

Suzanne Parisian, MD

Center for Genetics and Society – February 2005

Another lesson on what we don’t know about early embryo development…

Embryo Cells Not Like Peas in a Pod

“In a mammalian embryo, all cells are equal—or so biologists believed. But a series of studies suggest that the fate of individual cells might be determined much sooner after conception than previously thought.

“In some non-mammals, such as fruit flies, there are different concentrations of certain molecules in different parts of the egg. When the egg cell divides, the ‘daughter’ cells use this as a kind of grid reference to work out where in the egg cell they have come from and what they should become. This pattern is inflexible: split an insect egg by pinching it in the middle and you don’t get twins; you get a front end and a back end of the insect.

“Mammalian embryos appear to be much more flexible. If you take a mouse embryo at the two-cell stage and destroy one of the cells, you still get a complete mouse. This originally led to the idea that cells in early mammal embryos are totipotent—able to form any cell type.

“But recent studies have raised doubts. And now, after a painstaking set of experiments, Magdalena Zernicka-Goetz of the Wellcome Trust/Cancer Research UK Gurdon Institute in Cambridge and her team have shown that cells in four-cell mouse embryos are different from one another (Development vol 132, p 479)….”

NewScientist.com – March 12, 2005

Assessing the health risks to children conceived through in vitro fertilization…

IVF Embryos May Be Starved of a Vital Ingredient

“The lack of natural growth factors in the fluid in which IVF embryos are grown could have lifelong effects on people conceived this way. That is the implication of a study on mice by Australian researchers, who say preliminary studies of human embryos back their claims.

“Although the latest review of IVF safety found no differences between 8-year-olds conceived normally and those conceived by IVF or ICSI, the possibility of long-term health effects still cannot be ruled out. There are certainly differences early on: singleton babies conceived by IVF or ICSI are more likely to have a low birthweight and to die soon after birth (New Scientist, 23 October 2004, p 10).

“Could these problems have something to do with the process of IVF or ICSI, such as growing the embryos in a dish for two to five days? Growth media have been developed by trial and error, and contain only a few amino acids and other nutrients. They have been kept simple in the hope of avoiding unanticipated effects….”

NewScientist.com – February 19, 2005

At Harvard, research and business trump ethics, but there are some pro-life lights shining through the moral fog…

Celling & Building a Culture of Death

by Bronwen Catherine McShea

Life and death at Harvard

“At Harvard, one can easily develop a skewed perspective on political reality amidst the hegemonic fog of left-liberal campus ideologies. For example, on crucial life issues such as embryonic-stem-cell research, campus ‘dialogue’ is largely determined by the monolithic enthusiasm of the deans and faculty for, say, the Harvard Stem Cell Institute (HSCI), launched last spring, which is busily developing stem-cell lines by destroying human embryos. It is telling that, in the wake of HSCI’s opening for business, Harvard faculty members hosted not a single public forum to engage the pressing ethical issues to which the rest of the nation—and the rest of world, given the U.N.’s new resolution recommending a ban on all forms of human cloning—seems very much alive.

“As a pro-life student on campus, I could rest content with the fact that Harvard is way out of step with the rest of the country on all such issues. But I also know that Harvard wields great power in public-policy debates. In February, Harvard scientists lobbied heavily with Massachusetts legislators and testified at a state senate hearing on this very issue. Many in the statehouse are committed to actively partnering with HCSI and other private research and biotechnology enterprises.

“Harvard’s power also extends greatly, if not so evidently, into abortion politics. In particular, Harvard Law School produces a large number of lawyers each year who go to the federal bench and state judiciary systems, and also into legislative politics and other forms of legal activism. And this year, partially in reaction to the election, the abortion lobby has seen renewed life on campus. Many young lawyers are committing themselves to the cause of ‘reproductive rights,’ with some planning career strategies for years down the line….”

National Review Online – March 2, 2005

Worth considering…

From After Virtue, Chapter 18

It is always dangerous to draw too precise parallels between one historical period and another; and among the most misleading of such parallels are those which have been drawn between our own age in Europe and North America and the epoch in which the Roman empire declined into the Dark Ages. Nonetheless certain parallels there are. A crucial turning point in that earlier history occurred when men and women of good will  turned aside from the task of shoring up the Roman imperium and ceased to identify the continuation of civility and moral community with the maintenance of that imperium. What they set themselves to achieve instead—often not recognizing fully what they were doing—was the construction of new forms of community within which the moral life could be sustained so that both morality and civility might survive the coming ages of barbarism and darkness. If my account of our moral condition is correct, we ought also to conclude that for some time now we too have reached that turning point. What matters at this stage is the construction of local forms of community within which civility and the intellectual and moral life can be sustained through the new dark ages which are already upon us. And if the tradition of the virtues was able to survive the horrors of the last dark ages, we are not entirely without grounds for hope. This time however the barbarians are not waiting beyond the frontiers; they have already been governing us for quite some time. And it is our lack of consciousness of this that constitutes part of our predicament….

After Virtue: A Study in Moral Theory, by Alasdair MacIntyre (University of Notre Dame Press, Second Edition, 1984), p. 263.

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