Biotechnology

Listening to DNA

The genome project is getting the buzz. But the real breakthroughs may come from labs out of the limelight, like Gene Logic.

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Listening to DNA

Which organ do you want to look at?” asks Jeff Tomlinson.

I’m sitting in front of a laptop with Tomlinson, director of strategic marketing for a suburban Washington company called Gene Logic. We’re scrolling through a list of body parts — stomach, skin, heart, pancreas, etc. — in a remarkably sophisticated genetic database that the company believes can revolutionize biomedical research. Subscribers, such as scientists and drug companies, can conduct virtual research by tapping into this vast storehouse of knowledge about genes and disease.

“Uh — breast?” I blurt out, wondering as I do whether I’m thinking about the breast cancer in my family, or just being a guy.

“OK,” Tomlinson says, “that’s fairly standard.”

We click on breast, and it is like no breast I have clicked on before.

It isn’t an actual breast, but a list of all the genes active in the breasts of several dozen women. We have the option of looking at the breasts of alcoholics, tobacco users, pre- and post-menopausal women, blacks and whites — more than 100 variables in all.

Because I’m stymied about which to choose, Tomlinson does a quick search on about a dozen women in their 50s.

A human has about 100,000 genes. At any time, in any tissue, only a limited number of them are expressed, or “turned on” to send cells the messages that guide fundamental biological processes, like growth. In the breast sample, 7,300 to 8,600 genes are activated — and only about 5,000 of the genes are the same throughout the sample. When Tomlinson calls up a sample of breast cancer patients, their patterns of gene expression are entirely different.

It has often been noted that the DNA sequences of any two people are more than 99 percent similar. Even a chimpanzee’s DNA is close to 98 percent similar to that of the average human. Gene Logic seems to have captured something interesting, which could be valuable for treating disease. This database shows that people with nearly identical DNA can have vast differences in genetic expression.

It also shows how uninformative, for all its grandeur, is the raw sequencing of the 3 billion base pairs, the building blocks in our DNA. The Human Genome Project, which is getting massive media attention as its nears completion, is just a first, crude step. The research that has the potential to change medicine, to produce new treatments and alter our very notions of disease, is happening largely out of the limelight, at places like Gene Logic.

When the sequencing effort got officially underway in 1990, at the beginning of the Human Genome Project, it inspired awe. Nobel laureate Walter Gilbert said reading the genome would allow us to “know what it means to be human.” Newsmagazines fantasized about a “Gattaca”-esque future in which a doctor would swab your cheek for a DNA sample, pop it into a machine and produce a genetic readout of your future health and potential.

The genome project has sped discoveries about disease and human evolution and criminal forensics. But the completion of this encyclopedia has become a largely symbolic milestone — it’s come down to a horse race between a company, Celera, and a government-funded consortium. Neither the public nor the private versions of the genome will tell us what all that DNA does. The bracing truth about molecular biology is that the more we learn, the more we realize what we don’t know. To understand the contribution that a company like Gene Logic may yet make, you have to start with that deflating realization.

Although we now have the letters of this so-called human alphabet, we’ve identified only about a third of the genes it spells. Fully grasping what these genes do will take decades because most diseases and traits result from a combination of many genetic and environmental influences. Too, different genes are turned on in different quantities, in different tissues of the body at different times.

It’s no wonder, then, that the genome project has not yet had much impact on health. “The effect on clinical medicine has been small up to now,” acknowledges Francis Collins, the director of the genome institute of the National Institutes of Health. But he adds, optimistically, “There will be an explosion of clinical applications in the next 10 years.”

That is certainly an optimist’s view, yet many biologists hold it.

Gene Logic occupies two newish red brick buildings in Gaithersburg, Md. The company was founded in 1996 and completed the first version of its major database last fall.

Much of the information was compiled from public sources by brainy software developers hired away from Lawrence Berkeley Laboratory. Gene Logic adds a crucial element: information about gene expression, which the company generates by collecting thousands of tissue samples and tallying up the genes turned on in them.

To do the tallying, Gene Logic uses large numbers of gene chips — silicon chips upon which are glued thousands of fragments of DNA. The company produces or buys the chips from a Silicon Valley firm, Affymetrix. After a largely automated process that takes a few days, the DNA on the chips reads the DNA in the tissue samples and feeds
terabytes of data into computers.

Most of the work goes on in a low-slung building formerly occupied by Oncormed, a company that did diagnostic DNA testing for things like breast cancer. Gene Logic absorbed Oncormed last year, mainly to gain access to its tissue sample network. It dropped diagnostic testing, which turned out to have limited value because disease genes tend to have dozens or even hundreds of mutations, each with a potentially different medical significance.

“It would be impossible to do mutation detections for 42,000 genes,” says Christopher Alvares, a former Oncormed employee who oversees quality control for the Affymetrix chip processing part of Gene Logic. “To do a complete genetic profile of every person would take tremendous resources.”

Gene expression appears to be more promising for medicine. Expression patterns can suggest biochemical pathways that might be enhanced or muted by a new drug or therapy. Gene Logic has already landed Pfizer and another top-tier pharmaceutical company as full subscribers to its database, and has also established collaborations with a handful of academic researchers. To hear these scientists discuss the results, the Gene
Logic approach is yielding a new paradigm of biological research.

“The chips identified literally hundreds of novel genes. A large portion of the genes were not even thought to be associated with cancer,” says Reginald Lord, a University of Southern California surgeon who is studying esophageal cancer in a collaboration with
Gene Logic and other scientists. “If we had taken the rational approach, formulating a hypothesis and testing it, it would have taken decades to come up with these genes. With this chip study you go straight to the money.”

Previously, Lord and his colleagues had been examining the effects of a limited number of genes in esophageal cancer. Suddenly, they had a real-time profile of the performance of 42,000 genes in their patients. (The Affymetrix chips used by Gene Logic can test the
levels of 42,000 genes at a time. The new Affymetrix chip tests for 60,000.)

Gene Logic doesn’t intend to become a drug company. It worked on esophageal cancer as a sort of pilot study, says Michael J. Brennan, the company’s 42-year-old, South
African-raised CEO.

A wealthy man with esophageal cancer approached Gene Logic seeking information about the best chemotherapy approach to treat his disease. (Company officials are stingy with details, citing privacy concerns as well as pending publication of the data.) To help the scientists get a grasp on the biochemistry involved, the patient ended up funding a study of esophageal cancer, a disease that hits about 15,000 Americans each year and is said to be the fastest-growing cancer in the developed world.

On one of two mornings I spent at Gene Logic, Jeff Tomlinson asked the computer to select the 500 genes most commonly expressed in the esophagus. For any of these genes a click took him to references in the medical literature, to similarities to other known genes in the huge federal databank, to flow charts of the gene’s function in biochemical pathways. When he drew up a top-500 list for cancerous esophagus, many of the genes were different.

“Right now, cancer has all these chemotherapy cocktails, with each chemical aimed at intervening in a particular biochemical pathway,” Tomlinson said. “With this database we can look at a pathway, and if it’s not over-expressing a gene, we know that part of the cocktail isn’t needed.

“If I was a patient with cancer, I’d want to come here and ask that,” he added. “Maybe I can drop one drug, and double the dose for another — so that if I have to poison myself, at least I know I’m doing it in the right direction. But we’re not supposed to say that
because this hasn’t been used yet to stratify patients. For the
moment it’s just a research tool.”

Like most biotech stocks, Gene Logics soared early this year on news that scientists were close to finishing the genome project. Its stock went from $6 on Dec. 2 to $152.50 on March 2. At that point, the company was worth $4.5 billion — three times more than U.S. Airways. The stock price sank, with other biotech stocks, after President Clinton and Britains Tony Blair called March 14 for unfettered research access to genetic data.

The markets reaction to the Clinton/Blair statement revealed how ignorant the market is about genome science. The markets responded as if the statement would hurt the biotech industry, when in reality the Clinton and Blair were obliquely criticizing the practices of Celera and a few other companies that patent raw DNA sequence information.

When its stock price was surging in January, Gene Logic got $270 million in fresh financing and plans to use it to expand the collection of tissue samples in its database from 2,500 to 30,000.

Whether pharmaceutical companies use Gene Logic or other databases (there’s really no
competition for the company’s exact product), the major firms are sinking millions of research dollars into data mining. Some are collaborating with genome companies; other drug giants are leaping in on their own. They are all amassing thousands of potential drug targets by scanning the genome.

The question is, who will be smart enough to organize the data intelligently? And when all is said and done, will the automation of biological knowledge take us closer to self-knowledge?

Arthur Allen writes on health, science and other issues for Salon. He lives in Washington.

Lean, green gene-counting machine

Incyte CEO Roy Whitfield gives biotech investors and patent critics a few lessons on genomic research.

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Lean, green gene-counting machine

Whatever visions of fame and fortune British-born Roy Whitfield had in mind when he first headed west to mine California’s rich veins of venture capital, he has far exceeded them by now. Fortune came first to the CEO of Incyte Genomics, who helped co-found the company in 1991. Today, Incyte supplies 18 of the world’s 20 largest pharmaceutical companies with the genomic information that has come to play a vital role in drug discovery.

And, increasingly, Whitfield now also finds himself in the public eye. Distressingly so, in fact. Incyte Genomics has become one of the most visible players in a pitched debate between academics and entrepreneurs over how to share the knowledge that’s rapidly being gained into the workings of the human genome. Now, as a rough draft of the complete Human Genome Project appears likely to be released in just a matter of weeks, the voices of dissent have become shriller than ever. Even heads of state have felt moved to make their views known.

And at much of this, Whitfield can only shake his head in wonder.

When President Clinton and British Prime Minister Tony Blair recently took the position that genome data should be made freely available to scientists everywhere, people holding biotech stocks stampeded to the exits. You were quoted at the time as saying the panic owed largely to a failure to distinguish between genome sequences and gene sequences. What distinction should investors be making?

What Clinton and Blair were talking about was genomic data — the raw code. When you have that, you actually don’t have any genes at all. The genes have to be predicted from the raw code. And so what Incyte and other companies in the genomics field have been doing for the past five to six years is sequencing the genes themselves. And we’ve managed to compile an almost complete list of those genes. What Clinton and Blair were talking about was making the genomic sequence freely available. And that’s been happening right along. But that’s quite different from the genes themselves, which is where all the commercial utility lies.

For example, when Chromosome 22 was published last December, the Human Genome Project scientists predicted we’d find 545 genes on that chromosome. But because we’d actually sequenced the genes at Incyte, we knew that over 1,000 of our genes would match that chromosome. So they missed nearly half of them. Don’t laugh. They admit it. It’s not like they don’t know about this problem. In fact, they said in their paper that they wished they had a transcribed gene sequence database, which is exactly what we have. And that, of course, is why almost all the major drug and biotechnology companies subscribe to our database.

Now, there’s a lot of academic value in the genome. It gives you things like the gene structure, the promoter regions and all that. It really is the crowning glory from a scientific point of view. But there’s not a lot of commercial value in that. Still, for most people, you say “human genome” and they automatically think you’re talking about all the genes. But that’s not the case. To find all the genes requires a database like ours. And another thing: Once you’ve found the genes, what you then want are physical copies, or clones. And we’ve archived all those so we can make them available to medical researchers worldwide.

In the last few weeks, Tony Blair has come out to say that public opinion should be weighed heavily in the ongoing debate over biotech regulatory policies. That means Britain now joins Switzerland and Iceland, two other countries that have insisted the public’s voice be heard. Do you feel the general public should be part of that discussion?

Absolutely. And the fact of the matter is that they’re involved already. I’m on the board of directors for the Biotechnology Industry Organization, which works all the time with various government agencies on issues surrounding biotechnology. This sounds like an exhortation to do something that’s already happening.

But what that really signifies is growing public awareness. People suddenly want to know what it means to have a copy of every human gene. What does it mean to have genetically modified foods? And these are all legitimate questions, right? So I see these as promising developments — much better, certainly, than people making ill-advised comments or policy decisions based on ignorance.

Incyte describes itself as the leading genomic information company, and, indeed, a recent article in the Wall Street Journal indicates that you hold over 375 U.S. patents on human genomic structures (essentially three times as many as any other organization) and that you have another 6,500 patent applications pending. Are those numbers accurate? And do you plan to make all that information publicly available?

Let me just clarify: What you’re talking about are full-length gene patents, where the medical use of the gene has been described as part of the patent application. As for making that information publicly available, your question actually is a classic example of the general misunderstanding I was just talking about.

What do you suppose happens when a patent issues? Just by virtue of being patented, the information is put into the public domain. So the patents that have already been issued — and we now have 400, by the way — are all, by definition, in the public domain right now. And it’s actually even broader than that, since we’re releasing more than just gene sequence databases; there also are other types of information that are even more valuable. And all that will be put online before the end of the year.

That will solve a huge problem, since, until now, a customer pretty much had to sink $1 million into computer hardware just to be able to run the Incyte database. But by putting all that data on the Internet, everybody will be able to come and use our computer power to perform their searches. So even though the information has been publicly available right along, there was a barrier in terms of computer power. That’s why, historically, it’s only been the drug companies that have been able to work with us. But now we can finally eliminate that last barrier.

But if the information is patented, isn’t there still a cost barrier?

No. That’s another great misconception about gene patents. What the debate is really about is licensing strategy. It’s not about patents at all. When people get upset about a patent, it’s usually because they think they’re going to be barred from using the information. But that only rarely happens. If you look at companies like Intel and Motorola, you’ll find they have thousands of patents. But you very rarely hear anyone complain that they’ve been barred from doing something — and that’s because the high-tech companies generally just cross-license each other. They look at the patent system as a way of getting a financial return on their R&D. And that’s exactly our approach. We license our patents broadly, not exclusively. And so far, drug companies have taken out over 30,000 licenses to our intellectual property.

What about academics and nonprofits? As I understand it, Celera Genomics has announced its intent to make its human genome sequence information freely available to academics without any restrictions whatsoever. Is that your intent as well?

Well, let’s just step back and talk about Celera for a moment. Celera made that statement over two years ago, when they first started, and, as far as I know, they’ve still not put a single bit of human data in the public domain. So I think we should have these debates once people have actually done what they said they were going to do. But as to your question: We absolutely mean to make our information freely available for academic and nonprofit researchers. For us, it’s really just a matter of getting the Web-based distribution mechanisms in place.

What exactly is the basis for asserting patent protection over a gene sequence, since what we’re talking about here is something discovered, as opposed to something invented or created?

Well, now that’s a loaded question. So let’s step back just a bit. Gene patents have been around for 20 years. They’re the whole basis of today’s biotech industry.

Incyte is getting quite a number of gene patents now and, all of a sudden, people are paying attention — and somehow forgetting that this is something that’s actually been of great benefit to the economy for the past two decades. That’s point No. 1. Then all this business about discovery vs. invention — are you familiar with taxol, the breast cancer drug that comes from the yew tree? Well, there again, you have something that’s out there in nature, but has to be purified and isolated before you can make it usable.

If you look at all the genes in the human body, they’ve been around for — what? — 200,000 years. Yet only in the last couple of years have the technologies been developed to purify and isolate those genes for the good of mankind. You saw a trickle of that with Genentech and Amgen, and now you’re seeing much more of it from Incyte and all the other genomics companies. And that’s revolutionizing medical research.

You just look at all the things that are happening today. Doing 100,000 gene scans of patient samples, new ion channels — all that. And it’s just great for the human race. So to imply that these things were just lying around out there for somebody to come along and pick up — well, that’s just a complete mischaracterization of what’s actually happened. People have put a huge amount of capital at risk to purify and isolate all these genes so they can be used for medical research. That’s great for the economy. And that’s just exactly what the patent system was designed to encourage.

Getting more specific, though, my question has to do with how broad the definition of use is. The U.S. Patent and Trademark Office says now that it will grant patents for genes wherever applicants can describe a plausible function. But often those explanations are broad and sketchy. In fact, a highly publicized controversy currently swirls around the development of CCR5 drugs designed to inhibit the transmission of AIDS. While Human Genome Sciences currently holds the patent on the gene that CCR5 targets, the HGS patent application made no mention of the potential HIV connection. And four other research teams, meanwhile, have since filed patents on the same gene that make far more specific claims about the gene’s potential role in the fight to stop AIDS. Under these kinds of circumstances, who should properly be able to claim royalties from the sale of CCR5 drugs? That’s the kind of dilemma I’m looking at.

Again, part of the problem with this debate is that people want to make sweeping generalizations. But every gene patent that’s filed is totally different — different genes, different information, different arguments, different competitors, different research, different methodologies, different patent examiners, the works.

So to make a generalization from the CCR5 matter would not necessarily do the biotech industry any service. That patent has got to have its day in court. It can be challenged just like any other patent.

But one thing I will say about gene patents from Incyte’s perspective is that our customers aren’t expressing any of these concerns. And that’s true throughout the biotech industry. So that means the very people who have to pay these royalties aren’t complaining. And people who wouldn’t have to pay any royalties in any event — which generally are the academics — seem to be the ones who have a problem. So it’s a bit strange, if you don’t mind my saying so. A big part of the problem here is that people’s knowledge of genes is pretty dim. And their knowledge of patents is even dimmer. You put the two together and you get plenty of confusion.

It seems to me that the debate, from a public policy point of view, should turn on questions like: What evidence do we have that these patents are good for the economy? What evidence do we have that they’re bad for the economy? And, as I’ve just told you, the evidence that they’re good for the economy is pretty compelling. You’ve got this biotechnology industry which is growing extremely fast and creating lots of jobs. There are a number of products — human growth hormone, insulin, you name it — that are already out there. And huge pipelines of new products are lining up at all the drug companies. We’re making quantum leaps in medical research.

Now, on the negative side, I say to people: Name an example of how one of these patents has restricted research or led to some negative result. Or make me an argument for why it’s been bad for the economy. And, you know, I’m still waiting.

Princeton molecular biology professor Lee Silver wrote recently in a New York Times Op-Ed piece that the debate over gene patents should be “focused on fair business practices and regulatory issues, not on ethics.” Is that consistent with your view?

Yes. But I wouldn’t phrase it that way. I think the real issues here are about licensing. These are not patent issues, for all the reasons I’ve indicated. From our perspective, the patent system is fundamental to the well-being of the global economy. Issues about any patent, really, always come down to licensing anyway. I think there’s a statute that says if you’ve got a patent on something and you can’t produce it, you have to license it. I’m just using that as an example of the sort of remedies out there to ensure the patent system works for the public good. And it’s an example of how you can fix patent issues through licensing policy. I think we’re looking at all the same issues when it comes to gene patents.

In the Incyte database, for example, there are many new and exciting targets for fighting Alzheimer’s, cancer and the like. But we don’t develop those drugs ourselves. Our policy is to license the patents broadly for a low, single-digit royalty to drug companies — which turns out to be great for them. The genes have already been discovered, purified and isolated, so they save years in drug development. We collect a small royalty and license our information broadly. It’s a win-win all the way around. And that’s the way the system should work. Let’s say Incyte didn’t do that and wanted a 50 percent royalty off every drug, or would only allow its own researchers to work on a particular gene. Then, maybe some public policy issues would need to be discussed. But again, there’s nothing different between that scenario and any other type of licensing arrangement.

It turns out, actually, that one suggestion put forth by a legal scholar at the University of Michigan would have the Patent Office issue “cross-licensing arrangements” in lieu of broad gene ownership patents. Are you comfortable with the Patent Office exploring alternatives like that?

Again, if it ain’t broke, why fix it? I really think the lack of empiricism here is quite appalling. Where is the problem? We are licensing these things nonexclusively anyway. I just wish people would take an intellectually honest view of what’s actually going on instead of projecting problems before they occur. I mean, I keep on hearing academics say, “This is bad because it’ll inhibit research.” But I’m still waiting to see the examples. Where is research being stopped? The fact is, through access to our data, researchers now have thousands more genes to work with than ever before.

So, basically, the great debate amounts to a lot of hand-wringing over nothing?

Yes. At this point, that is empirically the case.

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Mark Compton monitors technology trends from a comfortable perch midway between the Silicon Valley and Oregon's Silicon Forest.

Mutant food

A lawsuit against the FDA reveals documents that show even the agency's own scientists have doubts about the safety of genetically modified foods.

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When Steven Druker filed a lawsuit against the U.S. Food and Drug Administration for its negligent oversight of genetically modified foods in May 1998, the act was written off as just another stunt by some anti-GM food activist trying to make a point. But now, the GM foods industry and the U.S. Food and Drug Administration have reason to be nervous.

A federal judge is reviewing witness statements and previously undisclosed FDA documents before issuing a summary judgement of a lawsuit Druker is leading on behalf of the Alliance for Bio-Integrity, nine university scientists and 12 religious leaders. The Washington-based International Center for Technology Assessment, a nonprofit organization that has brought previous lawsuits against government agencies on food and environmental safety issues, collaborated with Druker and has provided the lead counsel.

The suit charges the FDA with violating the very federal statute that created the agency, the U.S. Food, Drug and Cosmetic Act, because the FDA does not mandate the testing and labeling of GM foods. For its own part, the FDA asserts in its policy on GM foods that genetically engineered crops are no different than those created through traditional breeding methods. The agency bases its position on the fact that foods derived from traditionally bred crops have a history of safety. Thus the FDA takes the position that genetic engineering is just another traditional breeding method, and reasons that GM foods should be considered safe.

Whatever the judge’s decision, Druker’s actions have made public information that is very damning to both the FDA and the companies selling GM seeds simply because it highlights the central point in the controversy over GM foods: No one has proved beyond a doubt that GM foods and other products are not safe, nor has anyone proved beyond a doubt that these products are safe.

By now, most everyone in the U.S. has probably eaten GM foods in some form. According to the Biotechnology Industry Organization, genetically engineered crops accounted for 25 percent of the corn acreage planted in the U.S. in 1998, 38 percent of the soybean acreage and 45 percent of the cotton acreage. Because the FDA makes no distinction between GM crops and traditionally bred varieties, food producers are not required to separate or label their GM crops in the U.S. So without knowing it, you’ve probably eaten GM soybeans in the breakfast cereal you had this morning, in the chocolate bar you knoshed on this afternoon, and perhaps your baby has had it in his soy-based formula.

The very notion that people are eating foods derived from GM crops without their knowledge — or consent — offended Druker both as a lawyer and as a religious person when he realized this was happening back in 1996. He came upon this information while researching a book examining the relationship between science, religion and ethics. The more he researched, the more he became concerned about genetic engineering and the basic assumptions government regulators were making about the products of this science. Eventually, the 50-year old lawyer set aside his book and took up the cause of suing the FDA.

While he awaits the summary judgement of his lawsuit, Druker has kept a pretty packed schedule that has included an appearance before a panel selected by the FDA to discuss the safety and labeling issues of GM foods. Ironically, the agency has taken Druker’s arguments more seriously than much of the news media. What has made Druker’s lawsuit noteworthy to many editors is that it contends the FDA’s policy on GM foods infringes upon religious freedom rights and is in violation of the Religious Freedom Restoration Act.

This focus on the religious angle has had the effect of putting Druker in a camp with the anti-establishment fringe, a characterization that has stuck. In an Aug. 18, 1999, profile of the lawsuit, the Wall Street Journal covered only the religious aspects of the action, describing Druker as something of a small-town, Torah-thumping fanatic who was “gathering his Noah’s Ark of plaintiffs, many of whom share his mystical spirituality and distrust of authority.”

To be sure, 12 clergy leaders from a variety of established denominations are co-plaintiffs in Druker’s lawsuit — along with nine university scientists. Druker says the university scientists and the clergy leaders were each aware of both the religious and scientific aspects of the lawsuit before signing on. The religious aspects are important, Druker says, but have been overblown. The overriding concern of both clergy and scientists is that the FDA’s handling of GM foods has been unethical.

The lawsuit seeks to force the FDA, at the very least, to label GM foods, to inform consumers of the genes that have been inserted in their foods so they can make a informed dietary decision. At most, Druker and the others would like to see a recall of these products and mandatory testing. To achieve even part of their goals, Druker and the CTA counsel must prove that the FDA has not followed the law to ensure the safety of consumers regarding GM foods.

Druker and the CTA may have already won the war, even if the battle is still undecided. As part of the lawsuit, the FDA was required to turn over to Druker some 44,000 internal documents. These include memos from agency scientists criticizing the FDA’s developing policy on GM foods.

The policy, which was published in the Federal Register in May 1992, is regarded even by the FDA’s own scientists as an industry cheat sheet: “The initial intent of the document was to present scientific considerations and to avoid telling industry what tests to run and how to go about doing it,” said Louis J. Pribyl, an FDA microbiologist in a February 1992 memo.

Yet a major part of this policy is a flowchart that effectively tells a company not only what to test in a crop but what results will be needed for the product to be considered safe. By including the flowcharts and telling the companies what to test and what results to get to meet safety standards and by listing all the tests and the answers, Pribyl felt that the FDA made it possible for companies to tailor their tests to get the results they would need.

Prior to Druker’s lawsuit, evidence that FDA policy was written largely to favor industry was a set of loosely connected dots. Besides the published policy in the Federal Register, there were Bush administration statements about the FDA regulations between 1991 and 1992. Vice President Dan Quayle in particular said the policy was part of a “regulatory relief program” that was intended to ensure the dominant position of the U.S. biotechnology industry.

And finally, there was a special investigation by the General Accounting
Office, the investigative arm of Congress, of the FDA in 1994 that focused on potential conflicts of interest regarding several agency officials who had once been employed by the agro-pharmaceutical
corporation Monsanto. Chief among the targets was Michael Taylor, whose job it was at the FDA to oversee and approve the very policies that would regulate GM products. Prior to joining the FDA, Taylor was a partner at King & Spalding, Monsanto’s external counsel on regulatory issues. The GAO report found no improprieties on Taylor’s part. But the document did make the connection between Monsanto and one of the main authors of FDA policy.

Now, with the newly disclosed FDA documents in Druker’s hands, the holes in this picture are filling in. The published policy is based on the idea that genetically engineered crops are no different than those created through traditional methods. Yet in previously undisclosed FDA memos, at least 10 of the 17 scientists who took part in shaping the Federal Register document along with other FDA researchers invited to comment — including head scientists from the agency’s Division of Food Chemistry and Toxicology, Center for Veterinary Medicine, Biological and Organic Chemistry Section — cast serious doubts on the scientific evidence for this assumption.

As Linda Kahl, an FDA compliance officer, noted in a memo dated Jan. 8, 1992, the FDA’s approach to writing the policy was the equivalent of “putting a square peg in a round hole — are we asking the scientific experts to generate the basis for this policy statement in the absence of any data? It is an exercise in hypotheses forced on individuals whose jobs and training ordinarily deal with facts.”

Even the FDA official with approval authority over the policy, Biotechnology Coordinator James Maryanski, raised questions about the agency’s assumptions. In a letter to a Canadian government official dated Oct. 23, 1991, Maryanski acknowledged that there was no scientific consensus about the safety of GM foods. He also admitted that the potential for genetic engineering to introduce new compounds into foods that could trigger allergic reactions “is particularly difficult to predict.”

In these documents, Druker and the CTA counsel believe they have proved that the FDA disregarded warnings of many of its own scientists about the unique risks posed by genetically engineered foods; that it covered up these opinions; and took a public stance that was entirely the opposite in tone and message than the private, internal memos.

In October 1999, the FDA announced a series of meetings around the country to discuss the safety of GM foods. Maryanski, who participated in these panels, asserted, “We are meeting our goal of ensuring that these new products meet the same safety standards as traditional foods.”

One model GM product that agency officials like Maryanski hold up as proof of the safety of GM foods is the Flavr Savr tomato, but the new memos have bruised the product’s reputation. The Flavr Savr tomato was engineered to ripen slowly, to give tomatoes a longer shelf life. It had to undergo more stringent food testing because its developer, California-based Calgene, had applied for market approval prior to the enactment of the FDA’s new policy on GM foods.

In 1994, Flavr Savr failed as a consumer product because all the genetically engineered advantages were lost in the shipping and packing stage, which bruised the tomatoes and gave them an aged appearance. According to an FDA internal memo, Flavr Savr also failed to meet the agency standards of safety.

In an assessment that went to Maryanski and others, Robert J. Scheuplein, director of the agency’s office of special research skills, found a problem with some of the testing data on the Flavr Savr. Scheuplein was unsatisfied with the explanations of Calgene scientists about one difference between regularly bred tomatoes and the Flavr Savr.

Although he regarded the effect as small, Scheuplein did say: “The data do not show the Calgene product to be unsafe but the data fall short of ‘a demonstration of safety’ or of ‘a demonstration of reasonable certainty of no harm’ which is the standard we typically apply to food additives.”

With regard to how the agency was instructing its scientists to regard GM foods in testing, Scheuplein said, “It has been made clear to us that this present submission [the Flavr Savr] is not a food additive petition and the safety standard is not the food additive standard. It is less than that, but I am not sure exactly how much less.”

The chilling implication revealed in this memo is that all other GM crops have undergone less stringent testing. In fact, testing is handled not by the agency but through voluntary consultations between the companies and the FDA with company scientists running the tests.

Previously undisclosed papers such as these tell the story of how the FDA flouted its own laws and ignored the advice and warnings of its own scientists in the process of pushing through a food technology that seemed to have immediate benefit only for the producers — namely agrochemical companies including Monsanto, DuPont and Novartis.

The ramifications stretch far beyond the U.S. borders. Together, these documents with the resulting FDA policy confirm the very fears expressed last November by WTO protesters in Seattle: that globalization will lead governments to speed up industry growth at the expense of thorough public health precautions. This is precisely what has happened with GM foods.

“Before Druker, we had no hard evidence that our regulatory system was favoring industry,” explains Gabriela Flora, program associate on Agricultural Biotechnologies, at the Minnesota-based Institute for Agriculture and Trade Policy.

By connecting the dots between U.S. regulators and industry, the hard evidence from the Druker case along with public outcry could put the breaks on the once fast-moving industry that the U.S. government has tried so hard to foster. Already, GM crop producers are reeling from partial and complete bans of GM crops throughout the European Union and Asia.

And in the U.S., where GM food fights have paled in comparison to sentiments expressed by Europeans, the tide is turning. Major food producers like U.S.-based Archer Daniels Midland have cut back on the use of GM foods or agreed to segregate and label these foods in their exports to Europe. The recent failure of the WTO negotiations, which were intended to reduce trade barriers, has forced the Clinton Administration to step back from its goal of broadening markets for GM products.

“People from the U.S. Trade Representative’s office stand up and say we have the safest food supply and the strictest regulation in the world, but Druker is showing this isn’t the case,” says Flora. So countries that once questioned the integrity of the U.S. food supply and the integrity of U.S. regulators now have ample ammunition, thanks to Druker, to prevent GM foods — produced mainly by U.S. corporations — from entering their borders.

It is somewhat remarkable that an individual such as Druker would eventually have such an impact on the high-stakes development on the GM foods industry. As he describes it, his involvement began with a simple realization of serious ethical concerns. “What I could see was that there were plans to very quickly restructure a large percentage of the world’s living organisms and that the U.S. government had given it a green light,” Druker says.

In fact, a large community of government officials and scientists — including Gordon Conway and Gary Toenniessen of the Rockefeller Foundation — seemed to hold the same, favorable view. Druker said he was surprised to find that “these presumptions appeared to be dubious to eminent scientists who were not indentured to the biotech industry.” Druker sought out these scientists, many of whom hold faculty positions at some of the most prestigious universities in the U.S. and Europe — including the University of Minnesota, Northwestern University and the University of Leeds.

Before long, nine of these same scientists became plaintiffs in Druker’s lawsuit. What makes their action unusual is that the atmosphere inhabited by molecular biologists and other scientists engaged in biotechnology research is a clubby one. Dissenting views about genetic engineering are discouraged, says Phillip Regal, professor of ecology, behavior and evolution at the University of Minnesota.

Regal is one of the plaintiffs in Druker’s lawsuit. Having a negative view of biotechnology, Regal warns, can cost a researcher his chances at tenure, future employment in industry, and certainly can dry up his resources for research funding. The scientists joining Druker in suing the FDA have done so at great personal and professional risk.

Why are these scientists and Druker doing this? Because they take issue with the way in which the government, corporations, and a significant portion of the scientific community, appear to speak with one voice. That one voice consistently tells the public that the industry must move forward quickly to preserve the U.S. dominance in biotechnology. At the same time, it tells us not to worry — government and industry have already taken care that public health and the environment will not be endangered as we move forward with this technology.

By suing the government, Druker feels he is getting at the major source of the biotechnology juggernaut. The publication of these documents, which Druker has gradually added to the Alliance for Biointegrity Web site since last summer, will have the effect for biotechnology that the tobacco papers had for the cigarette industry: Others will gain ammunition that can be used in later litigation and export restrictions on GM foods.

So in many ways, Druker has already won even before the final judgement is in on his case. “[The FDA memos] are out, and they can never be covered up again,” he says. “If we cannot turn the tide against genetic restructuring within the bounds of science and law, perhaps economic realities will come into play.”

Economic realities have struck. Last month, Novartis and AstraZeneca announced plans to spin off and then merge their agricultural businesses into a new company called Syngenta and Monsanto followed suit nearly two weeks later with Pharmacia Upjohn. The message in these moves is clear: The companies have taken enough of a financial bath with their investments in GM products and are, in a way, washing their hands of these ventures.

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Kristi Coale is a San Francisco freelance journalist who covers science. She is currently working on a project on the environmental impact of agricultural biotechnology for the Center for Investigative Reporting.

Bill Gates pledges $4 billion for third-world medicines

Vaccines are not unlike software: They require a big investment up front, but then they're cheap to make.

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In February 1998, as Microsoft founder Bill Gates was began to plot how to unload some of his billions on charitable causes, his dad met with Dr. Gordon Perkin, who headed a Seattle-based health charity and knew from his contacts in the World Health Organization that many vaccines weren’t getting to the children they could help the most — kids in the third world.

“I brought the vaccine gap to the attention of Bill Gates Sr. Children in poor countries don’t get shots we take for granted here,” Perkin says. “And he said ‘I think this would be something my son would be interested in.’”

Last month, Perkin’s pitch to Gates culminated in a $750 million gift by the Bill and Melinda Gates Foundation to a global fund for children’s vaccines. Last week, at a Seattle love fest with Nelson Mandela and his wife Graca Machel, Bill Gates Jr. said the vaccine fund would eventually top $4 billion.

Gates’ gift could transform the world’s health. It could save millions of lives. And it has thrilled infectious-disease specialists, who see the initiative as potential leverage to prod states and drug companies into action against the microbial ills of the tropics.

“It’s a remarkably generous offer,” says Dr. Carole Heilman, director of the microbiology and infectious disease division at the National Institutes of Health.

Currently, the entire pharmaceutical industry earns only about $240 million per year from vaccine sales intended for poor countries — a fraction of what Eli Lilly earns from Prozac. The global fund that the Gates money helped create is expected to spend an additional $200 million a year for childhood vaccines in the third world.

Gates had already committed major funds for vaccine research, including $100 million for the development of an AIDS vaccine, a gift that dwarfs the estimatted $50 million that goes into AIDS vaccine product development each year.

“His gifts have completely revitalized the field,” says Dr. Seth Berkley, president of the International Aids Vaccine Initiative, which has received $26.5 million from Gates. Not all AIDS vaccine specialists are as ebullient about Gates as is Berkley, but they all appreciate the help. AIDS killed an estimated 2.3 million people last year, the majority in sub-Saharan Africa.

A key question is the extent to which Gates’ vaccine gifts will help create a market that stimulates the pharmaceutical industry to develop and produce vaccines for diseases like malaria and tuberculosis, which together killed 3 million people last year.

“What we’ve heard from industry is that implementation needs to occur for them to feel that it’s worth pursuing other vaccines,” says Heilman. By implementation she means the developing countries need to be able to buy vaccines at a price the drug companies can live with.

The drug industry has shown no great interest in remedies for third-world ailments. Of the 1,233 drugs licensed between 1975 and 1997, according to one report, only 13 were for tropical diseases — and only four of those were developed by the pharmaceutical industry.

UNICEF and the Pan American Health Organization currently are the main purchasers of vaccines for the third world, but they don’t have unlimited budgets. As a result, new vaccines take years to reach most third-world children. Vaccines against hepatitis B and meningitis, in use since the 1980s in the West, are infrequently used in Africa though they could save thousands of lives there.

Recently, a pair of Harvard economists, Jeffrey Sachs and Michael Kremer, proposed the creation of what amounts to multibillion-dollar prizes, contributed by governments and charities, for drug companies that deliver safe and effective vaccines for maladies plaguing the developing world. The idea is that while research money helps, the only true incentive for the drug companies is to have a full-price market for their products.

“The Gates initiative will hopefully achieve two goals,” says Kremer. “One is to get the existing vaccines out to people who need them. The second is to convince these companies there will be a market if they develop vaccines for malaria or TB or African strains of HIV.”

Africans have benefited little from the new AIDS drug cocktails, which cost about $15,000 per patient per year. Nor is it certain that the AIDS vaccines currently in clinical research trials — few enough as it is — would work on African strains of the disease even if they work on strains common in the United States and Asia.

Tuberculosis, which kills nearly 2 million people each year in the third world, languished as a research backwater for years until resistant strains of the bacteria appeared in U.S. hospitals. It still gets only about $60 million a year from the NIH compared to billions for cancer research.

Although the genome of the tuberculosis bacterium was recently sequenced, offering a juicy target for research, the pharmaceutical industry has shown little interest in developing a vaccine.

But Gates recently gave a new foundation headed by microbiologist Carol Nacy $25 million to develop effective drugs and vaccines for TB. The seed money could get the pharmaceutical industry interested. “To the extent that funding from the Gates Foundation increases incentives to tackle problems, it’s got to help,” says Ann Ginsberg, chief of the NIH’s tuberculosis branch.

Gordon Perkin now directs the foundation’s global health program, which has begun raiding universities and the NIH for talent. Regina Rabinovich, a senior administrator at the National Institute of Allergy and Infectious Diseases, was recently hired to head the foundation’s malaria vaccine program.

Biotechnology, particularly its computer-enhanced, digitized forms such as the effort to decode the human genome, has long fascinated Gates. “Bill is almost as excited about biotech as he is about information technology,” says Trevor Neilson, spokesman for the Gates Foundation.

In 1996, Gates enticed brainiac Leroy Hood, whose automated DNA-cloning machines made the Human Genome Project possible, to leave the California Institute of Technology to head the University of Washington’s biotechnology department. UC-Berkeley geneticist Mary-Claire King, who did groundbreaking work on breast cancer, followed shortly after. (Gates’ mother died of breast cancer in 1994.)

Vaccines are especially interesting to Gates, his associates say, because they can offer the kind of push-button public-health fix that appeals to technology wizards. But then, what software maker wouldn’t appreciate a killer app to fight viruses?

“Gates understands technology, and vaccines are the best preventive-health technology,” says Berkley. “In a lot of ways it’s similar to making software. You invest a lot of money up front but once you have it, it can be produced cheaply.”

Which is why the much-maligned Bill Gates, fresh from his whipping in Washington, could sit at a forum in Seattle last week and bask in the praises of Nelson Mandela, the Nobel laureate freedom fighter. “As long as we have men and women of this caliber,” Mandela said, “our country, the world, is safe, and we are going to continue making progress whatever the problems.”

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Arthur Allen writes on health, science and other issues for Salon. He lives in Washington.

Letters to the Editor

Will staying unmarried save your relationship? Plus: Camille Paglia sparks new "Sensation" debate; should technology change the way we have children?

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The case against matrimony
BY LARISSA PHILLIPS

(11/18/99)

How does Larissa Phillips think that by not getting married her child (or children) will be protected from the trauma of losing a live-in parent?
Most parents, married or not, are intensely committed to their children
for the long term. But children need their parents to be committed to each
other in the same way. And marriage is nothing if not a long-term, intense
commitment.

Marriage is a tough gig. So is being a child in a family where adults
just can’t seem to stay committed to their spouses.

– Anne Lewis

Larissa Phillips concludes her rant against her boomer parents’
narcissism by blaming them for the rise in divorce. Actually, the rise in the
divorce rate in the United States occurred in the 1940s, not the 1970s. The World War II
generation, not the boomers, were the first to break their marriage vows on a
wide-scale basis. The boomers were just following their parents’ example.

Secondly, the rate of divorce, like the rate of marriage, is down.
Divorced peaked in the early 1980s and has slowly, steadily declined. Many
boomers, having learned how dreadfully painful divorce was the first time, have
worked hard to avoid being repeat offenders.

Don’t get me wrong: The boomers have plenty to be held accountable for
in screwing up the social fabric. They have, in their incompetence, created
blissfully ignorant creatures like Phillips. If she has a child and a mortgage and is
living with the father of the child, she is, in the state of New York, a common-law wife —
whether she likes it or not. In the eyes of the state, she already are married.

– Carl Steidtmann

New York

Larissa Phillips thinks marriage is outdated and passi. She should try
being a divorce attorney. Do you know what I’ve seen in the last 10 years? Marriage, even if it ends in divorce, still protects women to a certain extent. It allows the less financially secure spouse,
usually the woman, to put in a claim for property division, spousal support
and child support upon the relationship. If Phillips has never been married, she
will lose many legal rights that married people now enjoy. If the father of
her child dies and he hasn’t made up a will, guess who gets the property
through intestate succession? It won’t be her. It may not even be their
child if they’ve never bothered to establish paternity. I hope that distant
cousin of her boyfriend enjoys her boyfriend’s interest in their house after
the boyfriend “kicks off.”

Obviously, I’m being a little flippant — but like it or not, Phillips is
losing out and is causing her child to lose out on some legal protections by
not tying the knot.

– Karen Moskowitz

Little Rock, Ark.

I am a 28-year-old from a “broken home.” I view the institution
of marriage with deep reservations, and currently am too emotionally exhausted to even date. I think that Phillips’ observation that the boomers taught by example
is valid; I also don’t think it’s the whole story.

For those of us who went
through our parents’ divorce, there is reluctance to go through that
ourselves. But from a generational viewpoint, I think we really don’t know
what marriage is really for. Commitment is not the problem; most of us want
long-lasting relationships. But we also know the reality: Not all relationships
are long-lasting and there are no absolutes. I think my
generation does not view marriage as something that either establishes such
a bond, or promises that such a bond will hold. So the real question is, “What does the institute of marriage do for us?” Until we redirect the premise of those time-honored vows, there
will continue to be grave doubts about the usefulness of blowing thousands
of dollars on a ceremony that just doesn’t seem to buy what it used to.

– Matthew Williams

Though some will undoubtedly be alarmed by Larissa Phillips’ explanation
for America’s falling marriage rates, she represents over 11 million of us
who live with unmarried partners in the United States today. Some
unmarried couples will get married eventually. Some are unable to marry
their partners (same-sex marriage, for instance, is illegal in every state
in the country). And others, like Phillips and myself, choose not to marry
because we are troubled by an institution with a failure rate as high as
marriage’s, and because of a wide variety of other political, religious,
philosophical, and financial reasons.

Despite our considerable numbers, people in unmarried relationships rarely
see ourselves as a community with common interests and experiences. Tired
of having our fulfilling relationships attacked by outsiders’ moral
stigmas, religious judgments, flawed social science research and
institutionalized penalties and discrimination, last year we decided to do
something about it. Our national organization, the Alternatives to Marriage Project is working to create space for
people like Phillips to connect — and eventually to earn respect and
support for our relationships and families.

– Dorian Solot

Boston

Whither marriage?

(11/15/99)

I have been extremely disappointed with the “Whither
Marriage” series. I was expecting an in-depth look at
marriage, with perhaps demographic information on how marriage is
changing in our culture; interviews with people about the challenges and
joys of marriage; conversations on how to make marriage work; maybe
something on the growing movement to legalize same-sex marriages. (A
topic dear to my queer little heart.)

Instead — with the exception of “A Cooler Head Prevails” — the articles have all been shallow, flippant and predominately concerned with sex, infidelity and dysfunction.
And the right-wingers think they need to protect the institution of
marriage from people like me? It needs more protection from the
cynical attitude of people like you.

– Eris Weaver

San Rafael, Calif.


Hillary, Naomi, Susan and Rush. Sheesh!

BY CAMILLE PAGLIA

(11/17/99)

Camille Paglia glibly accepts the analogy from a reader that compares the Virgin Mary piece in the “Sensation” exhibit to a seder plate made of swastikas. Are we to take it then that elephant dung is the preferred symbol of a movement that depicts Catholics as less than human and which celebrates a genocidal murder of millions of Catholics that took place only two generations ago? Perhaps it’s true that some explanation is in order for the “Sensation” exhibit, but elephant dung is clearly not to Catholics what swastikas are to Jews. Paglia’s obliviousness to this obvious fact shows that she is no longer any different than those whom she criticizes when it comes to embracing any simplistic argument that’s available in order to justify her pet pronouncements.

– David Lichtenberg

The supposedly anti-Catholic “Dung Madonna” was created by a Catholic artist, not by the collector who owns it or the museum which displayed it. The remarks about the near impossibility of a “Seder plate made of swastikas” being shown at a publicly funded museum are a red herring for a very simple reason, what one might call the “N-word principle”: Just as African-Americans are free to use the N-word but whites are not, for obvious reasons, criticism from within the group is tolerated while criticism from outside the group is resisted. If such a Seder plate were created by a Jew, it would be disturbing in the extreme, but it would inevitably lead to the kind of discussion that it was intended to provoke. If it were created by a Catholic, however, it would inevitably lead to accusations of anti-Semitism, which would hardly be surprising. In creating his art, Chris Ofili, as a Catholic, had something to say about his Catholicism, regardless of how puerile some people may feel it to be. His art is not the fault of the Jews.

This all boils down to the question of what people believe the purpose of art should be. Is it something pretty to hang on walls or is it a medium for challenging people intellectually and provoking discussion about important topics? It is clear where Paglia stands on this — a surprising position for someone who prides herself on skewering sacred cows. Paglia rejoices over dead sacred cows only as long as they are someone else’s cows.

– Earl Hartman

No regrets
BY ANNA SORELLI

(11/17/99)

Like the author, I searched the Net after the end of my affair to find an article that spoke to my particular situation. Like Sorelli, I found many stories aimed at adultery-plagued couples trying to
repair their broken marriages to which I could not fully relate. I,
too, struggled with my “lack of guilt” since the breakup of my affair last
summer. Society says I should feel awful, but I don’t. I, too, prayed for
my lover’s life: not so much for him to live, but for him to live happily.
I, too, passed many hours alone or at work, afraid to return to the house
full of people and the loneliness I felt there.

Like the author of this article, I thank my former lover
for giving “me back my life when I didn’t even know I’d lost it.”

– Lynn Townshend

I‘ve been noticing lately how so many religiously inclined people claim to
have no problem with cheating on their spouses. Some even use their religion
to justify their deception: “In fact, [my religious faith] grew stronger,
reinforced by what I saw as a real-life demonstration of the tenet that
Jesus loves the sinner more.” Now I’m not very religious at all, nor do I
believe that monogamy is necessarily desirable or realistic for most people,
but I do believe in moral accountability. Jesus may love your lying,
cheating soul more because of your indiscretions, but in the immediate world
of emotions and consequence, you’re still a scumbag. And all the Bible-thumping in the world won’t change what you’ve done to someone who trusted you.

– Bryan Keller

New York

Sympathy for the Devil

BY DONNA MINKOWITZ

(11/18/99)

The real tragedy is that Donna Minkowitz has to defend her position.
The people who criticize her empathic take on outrageous situations are not liberals, but radical conservatives with different causes.
People don’t want to believe that normal people — like themselves — can
become what they consider “monsters.” It’s so much better to assume that
there is a wrongness about these criminals. It makes us feel safe. After all, we
could never do that — right?

– Bill Stiteler Jr.

What an outrage to suggest that “we all have something
in common with Matthew Shepard’s killers.” Honey, I have nothing in common with
the brutal, sadistic thugs who murdered Shepard. Maybe Donna Minkowitz does! I
find Minkowitz’s “method acting” form of journalism utterly repulsive.

– Tom Gordon

New York

Playing God
BY KRISTI COALE

(11/17/99)

What the author blithely overlooked was the actual day-to-day life experience of families where there are disabilities. As a social worker in District of Columbia a few years ago I had a mother
of three children, the youngest son autistic, as a client; she fantasized about
getting on a bus and leaving home. A neighbor’s son requires round-the-clock nursing; his father and mother have changed careers so that they can work out of the home.

It’s time we stopped romanticizing parenthood. In a world with too
many people, it’s great when people choose not to reproduce but instead
open their lives to others’ children.

– Vickie Leonard

Why does everyone seem so surprised and appalled by the drastic steps
some people take to create a more advantaged baby? Everyone knows that
beautiful, intelligent people get further in life (cruel but true). For a parent to want
to give these advantages to a child seems a natural reaction. We should be more shocked by the
fact that our society perpetuates the idea that if you’re not attractive,
intelligent and athletic, you’re not going to be happy. If there wasn’t
such a value placed on these birth-given traits (rather than ones achieved
though hard work) parents would wouldn’t go to such extreme measures to
try to give them to their children.

– Amy Crosby

Kristi Coale misses one key point: the connection between such invasive and manipulative pseudo-science and fascism. During the early part of the 20th century, concern about the “racial
health” of society was by no means limited to America. Our German
counterparts were also hot on the trail of the perfect human specimen, and
their conclusions continue to haunt us. One look at the article’s link –
to a bizarre, cold-blooded site that auctions off genetic material from
supermodels — provides a vulgar glimpse into our Brave New World. Despite
claims of an equal-opportunity egg- and sperm-donor policy, the stud
animals are all — you guessed it — lily white.

Genetic manipulation represents the last gasp of the poisonous, ethically
bankrupt farce known as Western medicine. The tiny dreams of tiny men
envision a fluorescent-lit dystopia in which neither warts, wrinkles nor
sagging tits need ever remind us of who we actually are — human. When we
steel our hearts to that unpleasant reality is when we truly attain immortality.

– Robert Arellano

Brave new world or future shock?
BY JON BOWEN

(11/17/99)

Jon Bowen writes: “Diabetics will wear sensors under
their skin to monitor glucose levels, with an internal reservoir dosing out insulin when the
levels drop.” In that case, I predict that there will be a lot of dead diabetics; when blood glucose
drops, the last thing you want is more insulin! Low blood sugar is caused by an excess of circulating insulin, and the usual treatment is to eat some sugar, fast. The fundamental symptom of diabetes is high blood sugar, and the reason that diabetics suffer from episodes of low blood sugar
is that treatments for high blood sugar (insulin and oral medications) are difficult to control
precisely and aren’t as flexible as the body’s own feedback system.

I looked up the BMJ editorial that apparently inspired this sentence of Bowen’s article. It
opens by describing a woman using what basically amounts to a surgically implanted insulin pump
paired with a continuous blood glucose sensor in some sort of automatic feedback loop. This idea
is nothing particularly new — it’s an extrapolation of diabetes-management technologies that exist or
are in development now. But when the author of the editorial says that this futuristic technology
is “almost here,” he probably means that he guesses that it may be perfected within the next 25 years.
For one thing, testing such a system is likely to be a long, tortuous process. I’m not eager to be
an “early adopter” of a technology when a bug in the software could easily kill me.

Bowen wonders whether “these new technologies will … strip away some of the mystery of living day to day in the sway of the natural world.” For some of us, this is already a moot point — there’s nothing particularly “natural” about giving yourself five injections every day. For that matter, most people’s everyday, normal activities, from wearing clothes to eating creme brulee, aren’t “natural” in any meaningful sense. No human beings, even the most “primitive” hunter-gatherers, live in a state of
nature unmodified by culture or technology.

These issues may also be moot because doctors’ and
medical researchers’ predictions about the pace of
developing technology are often overly optimistic.
For several decades, researchers have been predicting
a cure for diabetes “in five years.” I’m not holding
my breath.

– Janet Lafler


“Sleeping With Extra-Terrestrials” by Wendy Kaminer

BY ANDREW O’HEHIR
(11/17/99)

Andrew O’Hehir seems to praise Wendy Kaminer for her ability to
write sagely yet with humility of American susceptibility to
superstition and the accompanying hypocritical behavior of
our leaders and others who ought to know, and act, better. Then, with New Age-ish peeve, he takes it all back. “Maybe” he concludes, “it’s because Kaminer is completely
immune to the fluid, almost erotic allure of religious or
magical thinking that she has no real feeling for it. But
absent such fundamental sympathy, her book feels unhappily
reminiscent of a civics lecture: For all the excellent
points it makes, it’s earnest, self-righteous and easy to ignore.”

What is this? Her salient critique discounted because she
withholds soft and fuzzy “understanding” from the
criticized? Why need she be “sympathetic” with the
believe-anything boobies and religious non-rationals who
persist in foisting a murderous set of magical beliefs on
each succeeding generation? And since when is dry analysis
less valid simply because it disdains such mushiness?

Perhaps O’Hehir is one of those who fears to cut his
undoubted intellectual capacity and potential loose from
magic-based belief systems because he has been persuaded
that without a comfortably father-like God, mystically
powerful faeries, or some handy alien substitute, there will
be no “soul,” no beauty of spirit or mystery.
Gosh. We might have to grow up, see the magnificent,
awe-inspiring, truly beautiful universe for the stunning
question mark it is, instead of making up childish stories
about what it isn’t. We might actually find a compelling
need to make a religion that celebrates life instead of
condemning most of it to ignorance, repression or bland,
banal platitudes. We might actually become intellectually and morally responsible,
instead of hiding our ethical laziness behind some
all-excusing, all-explaining package of magical notions,
“erotically alluring” or not.

– David Yancey

O‘Hehir is quite right in calling Kaminer’s book “Sleeping With
Extra-Terrestrials” sanctimonious and elitist. Kaminer certainly has a point
about public displays of piety, especially with the current presidential
candidates vying with each other to be religious and righteous.
However — from my perspective as a pagan — most of “Sleeping With Extra-Terrestrials” bogs down in elitism and left-brain excess. I wonder if Kaminer is one of those curmudgeons who
critiques every TV show and movie she sees for “realism.”

Not all spirituality is mindless fluff; one couldn’t accuse the Dalai Lama, St.
Francis of Assisi or Mother Teresa of being lightweights. Similarly,
scientists can be every bit as corrupt, power-hungry and capable of deceit
as anyone else; Robert Anton Wilson’s “The New Inquisition” explored this in
depth.

– Crystal Di’Anno

Oakland, Calif.

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Brave new world or future shock?

Medical scientists predict technologies such as animal-to-human organ transplants and toilets that send info to your doctor.

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How will you know when you’re sick in the next millennium? When your toilet tells your doctor to tell you that you’re sick. Post-Y2K, your high-tech toilet, using sensors embedded in the bowl, will automatically analyze your urine for bacteria and shoot off a daily report via modem to your physician.

Other predictions are just as revolutionary without being part of your bathroom routine. Patients who are going blind will have biochip photosensors implanted in their eyes to act as artificial retinas. Diabetics will wear sensors under their skin to monitor glucose levels, with an internal reservoir dosing out insulin when the levels drop. And once scientists piece together the genetic jigsaw known as the human genome, they’ll forecast your health problems years in advance and design personalized treatments to get you back on your feet.

This is the future of health and medicine as envisioned by scientists peering into the next millennium from the brink of 1999. Forty-two international medical journals, led by the Journal of the American Medical Association (JAMA) Journal of the American Medical Association (JAMA) and the British Medical Journal (BMJ), are dedicating their pages this month to a “global theme issue” on new medical technologies and their impact on health care.

Scanning the articles is like hopping a time machine to a better, smarter world — a medical “Futurama” where doctors use “electronic noses” to sniff out ear, nose and throat infections, where “smart” pacemakers monitor a patient’s blood oxygen levels and cardiac wall pressure, adjusting the heart’s pace from moment to moment. And there will be souped-up wheelchairs that can climb stairs and go barrelling through sand and gravel like Humvees.

And, in a bit of news guaranteed to prick up ears everywhere, doctors will grow artificial penises and vaginas and use them to replace worn-out or disfigured parts. Dr. Myron Murdock, director of the Impotence World Association recently told Reuters that within 25 years genetic research will make it possible for scientists to construct male and female genitalia by culturing human cells and growing them over a mold.

In other words, expect the bizarre in medicine’s brave new world. Hospitals are going to change drastically, according to Dr. Charles B. Wilson, a neurosurgery professor and director of the Institute for the Future at the University of California San Francisco. As part of the admission process, Wilson predicts in his BMJ article, patients will be implanted with sensors that automatically perform more than 40 laboratory tests.

Wilson predicts that ceiling vents in hospitals will be equipped with air monitors to scan incoming visitors and sniff out anyone who could transmit an infection to a patient. Intensive care units will disappear, and we’ll see the emergence of “transportable intensive care beds” complete with sensors to monitor patients’ vital signs and deliver ventilation.

And in a scene straight out of “Star Wars,” robots will go tooling around our hospitals like automated candy stripers, running supply services and filling pharmacy orders.

Gazing through the pages of this month’s medical journals, the future looks exciting. But, as Dr. David H. Mark writes in JAMA’s introduction to the global theme issue, “Technological progress, even when it is real progress, often leads to new problems, difficult choices, and unforeseen dilemmas. Clearly, technology is not an unequivocal savior. With it often come difficult social, ethical, and economic choices.”

A prime illustration of the progress-problem dichotomy — and the attendant ethical and economic issues — is the thorny debate over xenotransplantation. The chronic shortage of human organs has compelled some doctors to promote the use of animals — pigs and primates, mainly — as an alternative source for organ transplants. Research is now underway to determine the viability of cross-species transplantation, with scientists looking at the immunological barriers, physiological functions and the risk of infectious diseases.

But opponents are calling for a moratorium on the research, saying that xenotransplantation — “Frankenscience,” some call it — is expensive, unethical and ridiculously dangerous due to the high risk of transmitting animal viruses to humans.

This gulf of dispute has separated supporters and critics since the first animal-to-human experiments at the turn of the century. For a long time, though, the debate raged on a mostly hypothetical level. But with recent advances in genetic manipulation and the development of immunosuppressive drugs, xenotransplantation is looking less like science fiction and more like medicine’s next big thing.

One of the more radical prophecies put forth in Wilson’s article is the idea that animal-to-human transplants will become quite commonplace in the near future — so common, he says with tongue only partly in cheek, that pig farms will sit next to hospitals for easy access. Wilson says, “By 2010, xenotransplantation will be available.”

It shouldn’t be, says Alix Fano, director of the Coalition for Responsible Transplantation and author of the 1998 book “Lethal Laws: Animal Testing, Human Health, and Environmental Policy.” “The risks are way too great,” she says. The FDA has acknowledged the risk, and yet the research goes on. In Fano’s view, “it’s inconsistent for agencies to continue to invest in a technology that could spread disease.”

Dr. Harold Vanderpool, a professor in philosophy of medicine at the Institute for Medical Humanities at the University of Texas Medical Branch in Galveston, serves on the FDA subcommittee on xenotransplantation. Vanderpool, who authored a BMJ article on xenotransplantation for the global theme issue, doesn’t deny the risks.

“The possibility of passing on diseases — many of which we haven’t identified yet — is a real concern,” he says. “The risks are great enough to require vigilant oversight. We have to be somewhat paternalistic about saying when trials can go forward.”

Vanderpool says that scientists are nowhere near ready to begin clinical trials on humans, but he believes the genetic research should continue, with the hope that xenotransplantation can someday be proven safe and effective. He says, “The probable benefits outweigh the probable risks.”

For Fano, “probable” is the key word. “The benefits have never been proven,” she argues. “Since 1906, 83 people have received animal organs and they’ve all died — most within a few hours or days.”

Still, the push for progress goes on. Fano believes that, if you follow the money trail, you can trace that push to the biotech companies who stand to cash in if xenotransplantation develops into a full-fledged industry. It’s a simple case of misplaced priorities, she says. “Is it fair to commit $35 billion a year to xenotransplantation when 50 million American lack basic health care and 50 million more are uninsured?”

Maybe not fair, Wilson says, but medicine must continue its forward march regardless of money issues. “Cost concerns cannot prevent the advance of science,” he says. And if the wealthy have a better chance of reaping the rewards of expensive high-tech medicine, that’s just the inevitable consequence of a society divided into haves and have-nots. “Someone who’s poor is less likely to get a new heart — or a new car. In a perfect world, this wouldn’t be true.”

But the xenotransplantation debate raises questions that go beyond financial nitpicking to the very core of what it means to be a human being. We tend to view the human heart as the locus of personality and soul; of our humanness. And that doesn’t bode well for the spiritual well-being of cross-species transplant recipients.

“How will the recipient feel,” Vanderpool wonders, “when he realizes that inside him beats the heart of a pig? Is he not fully human? A chimera of some kind? The whole notion of humans walking around with animal organs is an idea that most people haven’t come to terms with.”

But for scientists at work at century’s end, Vanderpool says, playing God just comes with the territory. “On all levels of truly innovative scientific advances, human beings are manipulating nature in ways that are surprising and, for some people, alarming. Xenotransplantation will raise a new specter for people who feel it’s unwarranted to cross boundaries in nature with impunity.”

For Wilson, those boundaries fluctuate with the societal climate. “When I was in med school,” he says, “people would die before they’d take blood from a black person.” Our cultural qualms can’t interfere with progress, he says, and in the case of xenotransplantation, “We’ve been given the wisdom to do what is a step forward for humanity. There will always be people who talk about the immorality of progress,” he says. “To get full accord is an unattainable goal.”

The only thing as inevitable and obdurate as the advancement of science may be the debate over the advancement of science.

Vanderpool takes a historical view. When the idea of in vitro fertilization was first introduced to the public, he points out, “There was enormous outrage and controversy, a great wringing of hands. But when Louise Brown [the first test-tube baby] was born in 1978, and she was healthy and normal, the controversy died down. The controversy tends to settle when you see the wonderful human results right before your eyes.”

It’s too early to tell whether we’ll see wonderful human results from xenotransplantation — or smart toilets, or electronic noses, or artificial penises — or if these new technologies will instead strip away some of the mystery of living day to day in the sway of the natural world. Science marches forward now, history steps in later to judge.

“Only the future will tell if this is for the betterment of humankind,” Vanderpool says, “or if it’s destructive.”

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Jon Bowen is a frequent contributor to Salon.

Page 13 of 14 in Biotechnology