Health

Justice Seizures: The case of the supreme seizure:…

July 31, 2007 on 12:24 pm | In Uncategorized | Comments Off Justice Seizures: The case of the supreme seizure:

Roberts, 52, fell on a dock after having a "benign idiopathic seizure," said Kathleen Landin Arberg, the court's public information officer. She said that Roberts has "fully recovered from the incident" but that he would remain at Penobscot Bay Medical Center here overnight for observation.

Arberg said that the chief justice, who has presided over the court for two terms, received minor scrapes from the fall but that a "thorough neurological evaluation . . . revealed no cause for concern."

She said he experienced a similar event in 1993 but had no recurrence until yesterday.

That last sentence is reassuring. If he's had seizures before, especially so long ago, then he likely has a benign seizure disorder (i.e. mild epilepsy). It's worrisome when an adult who has no prior history of seizures suddenly has one. It can be a symptom of something more serious - brain tumors or a stroke, for instance. But according to news reports they've checked for all of those things and all is well. There's no reason to expect this to interfere with his job, either. If he flew airplanes for a living it would, but a seizure disorder has no bearing on his ability to think.

Seizure disorders were once called "the sacred disease." Hippocrates knew they were caused by a brain malfunction, but that insight was lost by the Middle Ages. A good overview of the basic physiology and just about everything you might want to know about seizures can be found here at the Epilepsy Museum. Yes, the Epilepsy Museum! The famous people and art pages are especially enlightening.

F.D.A. Scientist Warns of Risk From Diabetes Drug

July 30, 2007 on 3:50 pm | In Uncategorized | Comments Off

GAITHERSBURG, Md., July 30 — A federal drug safety official recommended during an advisory committee hearing today that Avandia, a controversial diabetes medicine made by GlaxoSmithKline, be withdrawn from the market because it increases heart risks.

Dr. David Graham noted in a written preview of his presentation that Avandia is no better at controlling blood sugar levels than similar diabetes medicines like Actos, made by Takeda. With a clear risk to the heart, and nothing to recommend it over other therapies, Avandia should be withdrawn, Dr. Graham argued in written remarks.

Dr. Graham is scheduled to speak to the committee later today. But it is not clear that the advisory committee, or indeed the Food and Drug Administration itself, will agree with Dr. Graham, a drug safety official at the F.D.A. who has a long history of arguing against the use or marketing of some widely-used drugs.

The committee may instead recommend that Avandia’s label include stronger warnings about its heart risks.

A committee vote is scheduled for later this afternoon.

The F.D.A. called the advisory committee meeting today after a study, published in May in the New England Journal of Medicine, called into question the safety of Avandia.

Since then, the controversy about Avandia has wounded GlaxoSmithKline and led to severe criticism of the F.D.A., which has known for a year that Avandia might increase the risks of heart attacks but waited until May to warn patients about a possible risk.

This delay has helped to push through legislation on Capitol Hill that would provide the F.D.A. with more authority and money to police the safety of marketed medicines. Both the House and Senate have passed F.D.A. reform bills but a conference committee has yet to come to agreement.

About a million patients in the United States took Avandia last year, and a similar number took Actos. Since May, Avandia’s sales have plunged.

Many patients who take Avandia, and their doctors, have been presented with conflicting advice about whether to switch to other drugs.

The controversy largely revolves around whether several highly complex statistical analyses of dozens of studies of Avandia have shown that the drug is too dangerous to use.

There are fierce disagreements about the answer to this question not only among academic experts but within the F.D.A. itself.

The heart attack risk comes on top of a problem with swelling that has long been known to occur in those taking both Avandia and Actos. The swelling is especially risky for patients suffering from heart failure.

GlaxoSmithKline argued forcefully before the committee that its drug is safe.

Dr. Murray Stewart, a GlaxoSmithKline vice president, said that in recent months the company has examined data from several large managed care companies in the United States that altogether included 1.35 million diabetes patients.

The company’s analyses, he said, showed that patients who took Avandia suffered no greater risk of heart attack or death from heart problems than those taking other diabetes medications, including Actos.

The hearing began today with a presentation by Dr. Robert Ratner of the MedStar Research Institute in Washington, about the epidemic of diabetes.

He noted that each day in the United States, there are 4,100 new cases and 810 deaths from diabetes. In addition, 230 patients suffer amputations, 120 suffer kidney failure, and 55 go blind because of the disease every day.

He said that while controlling blood sugar levels has proven health benefits in the short term, no study has proved that diabetes drugs extend lives.

“We’re not keeping people alive with our drug therapy because our drug therapy isn’t adequate,” he said. And he said that no diabetes medicine has conclusively proven that it helps protect the heart. He also noted that diabetes patients often fail to take their medicines properly, and doctors often fail to treat the disease aggressively enough.

“Why do we need new therapies for type two diabetes?” Dr. Ratner asked. “We have an epidemic of diabetes and its complication that will soon swamp our medical delivery system.”

Most diabetics die from heart disease, since diabetes has severe effects on the heart. If Avandia actually increases the risks of heart attacks, that “denotes a serious limitation” of the drug’s usefulness, an F.D.A. reviewer concluded in a report before the meeting.

Advances Cited in Research on Multiple Sclerosis

July 30, 2007 on 3:17 pm | In Uncategorized | Comments Off

Medical researchers have made a significant advance in understanding multiple sclerosis, a common neurological disease that causes symptoms ranging from muscle weakness to paralysis.

The disease is one in which the body’s immune system mistakenly attacks the electrical insulation of nerve fibers. The cause is part genetic and part environmental, but researchers trying to identify the relevant genes have endured repeated frustration. Their approach has been to guess what genes might be involved and see if patients have abnormal versions.

This guesswork has produced more than 100 candidate genes in recent years, none of which could be confirmed except for long-known variants in the mechanism used by the immune system to recognize proteins that are foreign to the body.

In three articles published online yesterday in The New England Journal of Medicine, three teams of researchers say they have identified, by separate routes, new genetic variants that contribute to the disease.

One team used a new, advanced gene-hunting method called Whole Genome Association, which has racked up a string of successes with major diseases in the last few months. The other teams used the candidate gene approach, but because all three teams identified the same gene, the researchers say they are confident they have opened a new window into the cause and possible treatment of multiple sclerosis.

The gene makes a substance called the interleukin-7 receptor, a protein that enables cells of the immune system to respond to a control agent. Researchers believe the receptor is part of a biochemical pathway involving many genes; defects in any of these genes may lead to the disease. It is now possible to explore the pathway, they say, in the hope of devising treatments to correct the disease-causing process.

The new research is the product of several large teams at universities in the United States and abroad who have coordinated their publications and pooled their data for analysis.

The leaders of the Whole Genome Association Study include David A. Hafler of Brigham and Women’s Hospital in Boston; Stephen L. Hauser of the University of California, San Francisco; and Jonathan L. Haines of Vanderbilt University Medical Center in Nashville. The two candidate gene studies were headed by Dr. Haines and Jan Hillert of the Karolinska Institute in Stockholm.

Because the course of the disease is unpredictable, clinical trials are hard to conduct, said Dr. Kári Stefánsson, chief executive of Decode Genetics in Reykjavik, Iceland. “But once you have an ironclad discovery, as I believe the interleukin-7 receptor is,” Dr. Stefánsson said, “then you have the motivation to endure the expense of a long clinical trial.”

The full list of principal investigators participating in the Whole Genome Association study is as follows: David A. Hafler of the Brigham and Women's Hospital; Eric S. Lander and John D. Rioux of the Broad Institute and Massachusetts Institute of Technology; Stephen L. Hauser and Jorge R. Oksenberg of the University of California, San Francisco, Alastair Compston and Stephen Sawcer of the University of Cambridge School of Clinical Medicine; Margaret A. Pericak-Vance of the University of Miami School of Medicine and Jonathan L. Haines of the Vanderbilt University Medical Center.

Without U.S. Rules, Biotech Food Lacks Investors

July 30, 2007 on 2:55 pm | In Uncategorized | Comments Off

This little piggy’s manure causes less pollution. This little piggy produces extra milk for her babies. And this little piggy makes fatty acids normally found in fish, so that eating its bacon might actually be good for you.

The three pigs, all now living in experimental farmyards, are among the genetically engineered animals whose meat might one day turn up on American dinner plates. Bioengineers have also developed salmon that grow to market weight in about half the typical time, disease-resistant cows and catfish needing fewer antibiotics, and goats whose milk might help ward off infections in children who drink it.

Only now, though, do federal officials seem to be getting serious about drafting rules that would determine whether and how such meat, milk and filets can safely enter the nation’s food supply.

Some scientists and biotechnology executives say that by having the Food and Drug Administration spell out the rules of the game, big investors would finally be willing to put up money to create a market in so-called transgenic livestock.

“Right now, it’s very hard to get any corporate investment,” said James D. Murray, a professor at the University of California, Davis, who developed the goats with the infection-fighting milk. “What studies do you need to do? What are they looking for?” he said, referring to government regulators. “That stuff’s not there.”

But some experts caution that even if the F.D.A. clears the regulatory path in coming months, investors and agribusiness companies might still shy away. Many fear that consumers would shun foods from transgenic animals, sometimes referred to as genetically modified organisms, or G.M.O.’s.

“The companies we have spoken to have gone organic, and they are very concerned, at least up to the present time, of having G.M.O. associated with their name,” said Cecil W. Forsberg, a professor at the University of Guelph in Ontario, Canada, who helped developed the “Enviropig” with the cleaner manure. Smithfield Foods, for one, the world’s largest hog producer and pork processor, says it is doing no research on genetically engineered animals.

Critics say changing the genes of animals could lead to potentially harmful changes in the composition of milk or meat, like the introduction of a protein that could cause allergic reactions. They say there could also be risks to the environment if, for example, extra-large salmon were to escape into oceans and out-compete wild salmon for food or mates. Some also say that some of the processes used to create transgenic livestock can harm the animals themselves.

The federal guidelines would come after more than 15 years of talks and false starts at the F.D.A., a delay irking not only developers of the transgenic animals but also critics of biotechnology.

“The fact that the agency has sat there for years staring this problem in the face and really hasn’t come up with a clear way to regulate this is abdicating its responsibilities,” said Joseph Mendelson, the legal director of the Center for Food Safety, a Washington advocacy group.

Even now, the F.D.A. will not say when the rules will be ready.

“We want to get it out, but we also want to get it right,” said Julie Zawisza, a spokeswoman for the agency, which declined to make any other officials available for comment.

Some industry executives and former and current government officials say one reason for the delay was that some government officials, in part because of a preference for fewer regulations, wanted less stringent rules than the F.D.A. is considering.

Meanwhile, the biotechnology industry is actually pushing for the tougher standards.

“Our overarching goal is to have public confidence in our products,” said Barbara Glenn, the managing director for animal issues at the Biotechnology Industry Organization, a trade group. “We won’t have that unless we have a very strong review process.”

The F.D.A. is turning to transgenic animals after having tentatively declared in December that milk and meat from livestock that is cloned — but not otherwise genetically manipulated — was safe for people to eat.

The F.D.A. considers clones to be less biologically radical than genetically engineered animals — which instead of being mere replicas of naturally occurring animals are given foreign DNA, usually from another species.

Larisa Rudenko, a senior biotechnology adviser in the F.D.A.’s veterinary drug division, said in a May presentation at the biotechnology industry’s annual convention that each new type of genetically engineered animal would require approval for use in the food supply. That will be done, she said, under the umbrella of existing rules for drugs used in treating animal diseases.

While the implanted gene is somewhat like a drug, the existing rules would have to be stretched to fit.

But industry executives and some former agency officials said it was unlikely that Congress would enact totally new laws for transgenic animals. And using the drug laws, they say, would provide tighter control than an alternative approach of using the rules governing food additives. Agency officials have said that the veterinary drug rules would be used, and they have already been overseeing some experimental work on that basis. But they continued to debate the issue, and the policy has never been made official.

The regulatory guidelines would indicate how the drug rules would be interpreted for transgenic animals, and what types of data would be needed to prove safety and efficacy. But there are open questions about how the drug rules would actually translate. While a chemical drug must be shown to be consistent and stable, for instance, it is unclear how that standard would apply to a gene passed from generation to generation. Some critics say that while the drug rules do provide fairly strict regulation of food safety, there are drawbacks to adapting that approach. Because applications for approval of drugs are confidential, for instance, there would be no opportunity for public comment before the agency acted.

“In order to create confidence in a new technology, you really don’t want behind-closed-door proceedings,” said Margaret Mellon, director of the food and environment program at the Union of Concerned Scientists.

Another worry is that the F.D.A. might not have enough expertise or authority to conduct a vigorous review of the environmental impact of transgenic animals. The F.D.A. has dismissed this concern, however, saying it has sufficient expertise and can consult with other agencies.

The biotechnology regulatory branch of the Department of Agriculture created an animal division last December to figure out what its role should be.

Genetically engineered animals are often created by injecting the gene of interest into a single-cell embryo. A more recent technique that is more efficient is to put the gene into a skin cell and create an embryo from that cell by cloning.

In both cases, the embryo with the foreign gene is then implanted into the womb of a surrogate mother. After some transgenic animals are born, additional ones can be made by conventional breeding, because the foreign gene generally will be passed on to some of the offspring, as would any other gene.

The fast-growing salmon is the transgenic animal that has been swimming upstream the longest at the F.D.A. Its developer, Aqua Bounty Technologies of Waltham, Mass., has been working to win agency approval for about 10 years. Aqua Bounty’s fish are Atlantic salmon that have been given a growth-hormone gene from the Chinook salmon. They have also been equipped with a genetic on-switch from a fish called the ocean pout, a distant cousin of the salmon.

Normally, salmon produce growth hormone only in warmer months, but the pout gene’s on-switch keeps the hormone flowing year round. That enables the Aqua Bounty fish to grow faster, reaching their market weight in about 18 months instead of 30.

Elliot Entis, Aqua Bounty’s chief executive, said the company had already given the F.D.A. studies showing that the fish were healthy and that the implanted gene remained stable over generations.

He said the company also had tests done to show that its fish contained the same level of fats, proteins and other nutrients as other farmed salmon and would not set off unexpected allergic reactions in people who eat them. The fish also taste the same as other farmed Atlantic salmon, Mr. Entis said.

“Nobody has ever analyzed salmon as closely as we have had done,” he said. But the F.D.A. is asking for more data on safety and potential environmental effects on wild salmon.

Industry executives say the Enviropigs would be the next candidate for F.D.A. approval. The pigs contain a bacterial gene that allows them to produce an enzyme that helps them more fully digest a vital nutrient, phosphorus, in their feed. That means less phosphorus in the manure, which in turn could mean less phosphorus running off into lakes and oceans, where it can cause algal blooms and fish kills.

MaRS Landing, a technology promoting organization in Ontario, is trying to find a corporate partner for the pig, said John Kelly, the agency’s executive director.

Less far along in the approval pipeline are pigs that contain a gene from the roundworm allowing them to produce omega-3 fatty acids, a nutrient normally found in fish that is good for the heart. That, in theory, could make eating pork or bacon healthier, although that has yet to be tested.

Jing X. Kang, an associate professor at Harvard Medical School who helped direct the project, said the researchers were looking for corporate backers while also trying to raise the level of omega-3 in the meat.

Carol Tucker Foreman, director of the Food Policy Institute at the Consumer Federation of America, a consumer advocacy group in Washington, said regulations might not assuage consumers, many of whom object to the genetic engineering of animals on humane or ethical grounds, more than on safety concerns.

“The fact that the F.D.A. has a powerful regulatory process for reviewing genetically engineered animals, far greater than they apply to genetically engineered crops, may not make any difference at all,” Ms. Foreman said. “Because that’s not what it’s all about.”

Race Based Medicine: A convincing argument against…

July 30, 2007 on 2:13 am | In Uncategorized | Comments Off Race Based Medicine: A convincing argument against basing drug treatment on race.