Lake Michigan Rising

Great Lakes water levels                                             reach highest point since 1998

Great Lakes water levels reach highest point since 1998

 July 10, 2015

 Image result for photos lake michigan high water chicago

METRO DETROIT — Water levels on the Great Lakes have not only recovered over the past two years, but as of June, they are higher than they have been since the 1990s.

All five Great Lakes and Lake St. Clair have passed their long-term averages as of October of last year — breaking more than a decade of low water levels — and they have continued to rise over time. The measurements come from the National Oceanic and Atmospheric Administration, the U.S. Army Corps of Engineers, and Environment Canada.

U.S. Army Corps of Engineers Chief of Watershed Hydrology Keith Kompoltowicz said the lakes along the southeastern side of Michigan — Lake Erie and Lake St. Clair — have both seen an 8-inch rise from May to June, in terms of the average lake level. Lake Michigan and Lake Huron, which are counted together, have gained more than that on the whole.

“If you look at the typical lake pattern (for those), the lake is usually leveling off instead of rising significantly this time of year,” Kompoltowicz said. “That’s a direct result of the extreme precipitation falling into the watershed of the southern Great Lakes in June.”

About 6.74 inches of water fell into the Lake Erie basin in June; normally, the lake receives an average of 3.47 inches of water. Kompoltowicz added that Lake Michigan and Lake Huron have seen the most dramatic increase in water levels since 2013: more than 4 feet. That is something that has happened on this scale only once in recorded history, back in the 1950s, he said.

Rainfall is not the only contributing factor to the lake levels. Andrew Gronewald, a hydrologist with the NOAA Great Lakes Environmental Research Lab, said that all the major drivers for lake levels have changed over the past few years.

In addition to over-lake precipitation, Gronewald said runoff entering the lake through tributaries and stormwater systems plays a factor, as does evaporation — where water in the lakes turns into a gas, lowering the overall water levels.

Evaporation primarily hits in the fall and winter, as temperature differences between the air and water — with colder air and warmer water — leads to evaporation and a drop in lake levels. Ice covers in the winter can reduce evaporation, as can colder water in the fall, Gronewald said.

“What we’re doing research on right now is trying to get a better understanding of what happened over the past two years that caused levels to rise so much,” Gronewald said. “It’s a combination of all the changes in all those drivers.”

In all, he said water levels are now the highest they have been since September 1998, though they should taper off the rest of the year. Typically, lake levels peak in June and hit their lowest point in January.

He said that at this point, there is no clear indication on what impact climate change is having long-term on the Great Lakes as a whole, due to all the variables involved.

“It’s unclear what the overall impact of climate change would be on all these different variables,” he said. “You have to look at them all at once. Increasing water temperatures could increase evaporation just as they did over the past 15 years, but it could also be that increased warming in general could increase precipitation, as well, and that’s something else we’ve seen.”

While the region has seen colder, snowier winters and more active storm systems in the past few years compared to the previous 15, Kompoltowicz said researchers do not know if this is going to be a long-term trend.

For the moment, though, Kompoltowicz said the rising water levels are beneficial for boaters wanting to get on the water, marinas trying to sell boat slips, and commercial shipping traffic, but for property owners along the shoreline, it can be more of a headache.

“Shoreline property owners are seeing smaller beaches, and there is more potential for erosion as strong storms affect the region,” he said. “I’ve talked to some folks that are watching their beach shrink from 20, 30, 40 yards of beach to 3-4 yards of beach because water levels have drastically risen over the past two years.”

 

 

Image result for photos lake michigan high water chicago

 

Higher water levels can also lead to water being pushed inland more easily during storm events — leading to increased flooding — though Kompoltowicz said that since each storm is different, a specific area would be affected differently by each one.

Gronewald said erosion also depends on how the water and waves interact with the coastline and any structures along it.

He said researchers are starting the 30-year adjustment for measuring equipment to account for isostatic rebound, a phenomena in which land at northern latitudes gains elevation as glaciers recede. This causes gauges in the northern end of the Great Lakes system to indicate water level increases more quickly than the southern end.

Every 30 years, researchers need to take new measurements using benchmarks on the lakes that coincide, roughly, with the sea level. Gronewald said all current and historical measurements are then adjusted against that new measurement point so that scientists can observe long-term trends.

When Preemies Were Freaks

 

Babies On Display: When A Hospital Couldn’t Save Them, A Sideshow Did

Lucille Horn and her daughter Barbara on a recent visit to StoryCorps in Long Beach, N.Y.StoryCorps

Close to a century ago, New York’s Coney Island was famed for its sideshows. Loud-lettered signs crowded the island’s attractions, crowing over tattooed ladies, sword swallowers — and even an exhibition of tiny babies.

The babies were premature infants kept alive in incubators pioneered by Dr. Martin Couney. The medical establishment had rejected his incubators, but Couney didn’t give up on his aims. Each summer for 40 years, he funded his work by displaying the babies and charging admission — 25 cents to see the show.

In turn, parents didn’t have to pay for the medical care, and many children survived who never would’ve had a chance otherwise.

Lucille Horn was one of them. Born in 1920, she, too, ended up in an incubator on Coney Island.

“My father said I was so tiny, he could hold me in his hand,” she tells her own daughter, Barbara, on a visit with StoryCorps in Long Island, N.Y. “I think I was only about 2 pounds, and I couldn’t live on my own. I was too weak to survive.”

She’d been born a twin, but her twin died at birth. And the hospital didn’t show much hope for her, either: The staff said they didn’t have a place for her; they told her father that there wasn’t a chance in hell that she’d live.

“They didn’t have any help for me at all,” Horn says. “It was just: You die because you didn’t belong in the world.”

But her father refused to accept that for a final answer. He grabbed a blanket to wrap her in, hailed a taxicab and took her to Coney Island — and to Dr. Couney’s infant exhibit.

Dr. Martin Couney holds Beth Allen, one of his incubator babies, at Luna Park in Coney Island. This photo was taken in 1941.

Dr. Martin Couney holds Beth Allen, one of his incubator babies, at Luna Park in Coney Island. This photo was taken in 1941.  Courtesy of Beth Allen

“How do you feel knowing that people paid to see you?” her daughter asks.

“It’s strange, but as long as they saw me and I was alive, it was all right,” Horn says. “I think it was definitely more of a freak show. Something that they ordinarily did not see.”

Horn’s healing was on display for paying customers for quite a while. It was only after six months that she finally left the incubators.

Years later, Horn decided to return to see the babies — this time as a visitor. When she stopped in, Couney happened to be there, and she took the opportunity to introduce herself.

“And there was a man standing in front of one of the incubators looking at his baby,” Horn says, “and Dr. Couney went over to him and he tapped him on the shoulder.”

“Look at this young lady,” Couney told the man then. “She’s one of our babies. And that’s how your baby’s gonna grow up.”

After all, Horn was just one of thousands of premature infants that Couney cared for and exhibited at world fairs, exhibits and amusement parks from 1896 until the 1940s. He died in 1950, shortly after incubators like his were introduced to most hospitals.

At the time, Couney’s efforts were still largely unknown — but there is at least one person who will never forget him.

“You know,” she says, “there weren’t many doctors then that would have done anything for me. Ninety-four years later, here I am, all in one piece. And I’m thankful to be here.”

Audio produced for Morning Edition by Jasmyn Belcher Morris.

StoryCorps is a national nonprofit that gives people the chance to interview friends and loved ones about their lives. These conversations are archived at the American Folklife Center at the Library of Congress, allowing participants to leave a legacy for future generations. Learn more, including how to interview someone in your life, atStoryCorps.org.

New Alzheimer’s Drug

 

Early signs that drug ‘may delay Alzheimer’s decline’

Couple with dementia

The first details of how a drug could slow the pace of brain decline for patients with early stage Alzheimer’s disease have emerged.

Data from pharmaceutical company Eli Lilly suggests its solanezumab drug can cut the rate of the dementia’s progression by about a third.

The results, presented to a US conference, are being met with cautious optimism.

A new trial is due to report next year and should provide definitive evidence.

The death of brain cells in Alzheimer’s is currently unstoppable. Solanezumab may be able to keep them alive.

Current medication, such as Aricept, can manage only the symptoms of dementia by helping the dying brain cells function.

But solanezumab attacks the deformed proteins, called amyloid, that build up in the brain during Alzheimer’s.

It is thought the formation of sticky plaques of amyloid between nerve cells leads to damage and eventually brain cell death.

Infographic showing difference between early and advanced Alzheimer's disease

Silver lining

Solanezumab has long been the great hope of dementia research, yet an 18-month trial of the drug seemingly ended in failure in 2012.

But when Eli Lilly looked more closely at the data, there were hints it could be working for patients in the earliest stages of the disease.

It appeared to slow progression by around 34% during the study.

So the company asked just over 1,000 of the patients in the original trial with mild Alzheimer’s to take the drug for another two years.

And positive results from this extension of the original trial have now been presented at the Alzheimer’s Association International Conference.

They show those taking the drugs the longest had the most benefit.

Dr Eric Siemers, from the Lilly Research Laboratories, in Indiana, told the BBC: “It’s another piece of evidence that solanezumab does have an effect on the underlying disease pathology.

“We think there is a chance that solanezumab will be the first disease-modifying medication to be available.”

The company also started a completely separate trial in mild patients in 2012, and these results could prove to be the definitive moment for the drug.line

Analysis

Today is not the day to jump up and down proclaiming a breakthrough in slowing the pace of Alzheimer’s.

The limited data which has been released is the scientific equivalent of a poll before a general election or a trailer ahead of a movie.

It provides captivating clues, hints and teases, but nothing definitive.

At the moment there is no medication that can slow down dementia. If such a drug was developed it could transform how the disease is managed.

People would still get worse, but they would spend more time in the milder phase of the degenerative disease rather than needing constant care.

In a field that has been plagued by repeated disappointment, even a hint of such a drug is an exciting moment.

Next year, when further trial results are due, we will know for certain whether solanezumab is the breakthrough everyone hopes it could be.

line

Potential breakthrough

Brain
Loss of tissue in a diseased brain compared with a healthy one

Dr Eric Karran, the director of research at Alzheimer’s Research UK, told the BBC News website: “If this gets replicated, then I think this is a real breakthrough in Alzheimer’s research.

“Then, for the first time, the medical community can say we can slow Alzheimer’s, which is an incredible step forward.

“These data need replicating, this is not proof, but what you can say is it is entirely consistent with a disease-modifying effect.

VIDEO INTERVIEW:  “I think we could be on the verge of a radical breakthrough” – Dr Eric Karran, Alzheimer’s Research UK

“We’ve never ever had evidence that we can affect the disease process.”

Clare Walton, the research manager at the Alzheimer’s Society, told the BBC: “The data hints that the antibodies are having an effect, it is promising and it’s better than no effect, but it’s inconclusive.

“After a decade of no treatments and many drug failures, it’s exciting to get promising news, but it doesn’t really tell us either way, and we need to wait for the phase-three study, and that is in 18 months.”

In the first stage of the original trial, which ended in failure, half of the patients with Alzheimer’s were given solanezumab and half were not.

A reanalysis of the cognition scores of the patients with mild Alzheimer’s suggested taking the drug had cut the rate of the disease’s progression by about 34%.

The implication is that the amount of cognitive decline normally seen in 18 months would take 24 months with the drug.

In the extension of the original trial, all of the 1,000-plus mild Alzheimer’s patients participating were given solanezumab.

So, at the end of the extension, half of them had been taking the drug for three and a half years while the other half had been taking it for two years.

The latest data shows those taking solanezumab for the longest time still had better scores of cognitive function.

This suggests the course of the disease was being slowed.

If the patients’ brains had continued to decline at the normal pace and the drug had been merely helping with symptoms, then all of the patients participating in the extension of the original trial – whether they had been taking solanezumab for three and a half or two years – would have had similar scores of cognitive function.

Oldest Roadside Attraction

Elephants Never Forget — And At 6 Stories Tall, This One’s Unforgettable

 

Lucy the Elephant has weathered a few storms in her home on the New Jersey shore. Many believe she is the oldest roadside attraction in America.  Brian Branch Price/AP

Roadside attractions mostly appeared in the U.S. with the rise of the automobile. Think of the massive Paul Bunyans in the Midwest, or all the oversize foodstuffs along highways throughout the country — most of which are designed to get people to pull their cars over for a closer look.

But the oldest surviving roadside attraction dates all the way back to the era of the horse and buggy. Her name is Lucy the Elephant.

At six stories tall, Lucy is hard to miss. The gray pachyderm towers over the main drag in Margate City, N.J., a sleepy beach town south of Atlantic City. Lucy has welcomed generations of visitors since she was dreamed up by a real estate speculator in 1881 to get people to stop by his otherwise empty section of beachfront property.

Richard Helfant grew up in Margate in the 1960s, when his favorite restaurant stood in the shadows of the decaying elephant.

“There was this hot dog stand called Lenny’s, and it was right here on the corner and that was open 24 hours a day,” Helfant says. “They had the best, the best hot dogs on the planet.”

Helfant and his friends would ride their bikes to the hot dog place at 2 or 3 a.m., buy hot dogs, break inside the elephant’s stomach and eat them.

In those days, Lucy was in such bad shape that she had been condemned to demolition, before being narrowly saved by a local citizens committee. Today, a reformed Helfant has his own key. He’s the executive director of the team that maintains the elephant, which has been restored and reopened with help from residents.

Lucy predates a lot of the roadside giants that went up as growing numbers of cars hit the road in the 1920s and ’30s, according to Brian Butko of the Senator John Heinz History Center in Pittsburgh.

“Early on, probably the most common were cafes that were trying to let people know exactly what they offered, and they were built in the shape of a coffeepot or a teapot,” Butko says.

More went up after World War II, with the most impressive collection to be found in California. Butko says that’s because of California’s combination of sunny weather, Hollywood fantasies and the state’s car culture.

But Lucy has outlasted many of her descendants.

_______________________________________________________________________Image result for roadside attractions photosThere are a half-dozen books available on roadside attractions.  The most recent is Amazing and Unusual USA  by Jeff Bahr and Janet Friedman, which “… (takes) you on a thrill-packed look at the weirdest, silliest, tackiest, and most amazing things in the country. You ll discover a side of America that you never knew existed, one that s filled with enormous animals, bizarre museums, odd events, and oversized furniture.”                 Call your public library.                ______________________________________________________________________

In the ’50s and ’60s, interstate highways literally bypassed many of the roadside attractions on the older roadways. A great number have fallen to development. Indeed, even Lucy was affected: She was moved two blocks away from her original spot to make way for condominiums.

Paradoxically, Butko thinks that the disappearance of many roadside attractions has rekindled interest in those that remain. Websites and apps nowadays, like Roadside America and Atlas Obscura, allow people to learn about and plan visits to roadside oddities.

Lucy the Elephant gets about 130,000 visitors a year. In addition to the price of admission, Richard Helfant raises money with the gift shop, which sells stuffed elephants, elephant jewelry and more. At one point, they even sold Lucy themed underwear — called Lucy’s Trunks.

The funds are important, because a tin elephant near the ocean requires constant, expensive maintenance. During Hurricane Sandy, for instance, the water flooded her toes.

But Lucy’s outlook is good. This landmark at least has supporters now who will fight for her survival.

source

A Kid’s World . . .

. . . As It Used to Be

Baby Blues

by Jerry Scott and Rick Kirkman
 __________________________
In the old days, a kid could say, “Bye Mom, I’m going to the park” and be entirely free for the day, with a stop back for lunch.  We could go anywhere on our bikes, arranged our own ball games,  snooped in interesting places like houses under construction.  Our world may have been safer then.  It was certainly less organized than a  kid’s world today.  We  liked it that way.  rjn

SmallZee, a Dog

In Memory of SmallZee

by George and Linda Lynch

On 12/30/03 a runty little female puppy was born to Sire Jargus and Dam Eva. She was one of three in the Z- 20 litter. She was diagnosed with a heart murmur which disqualified her for the guide dog program. We were asked to care for her in our home until she could have an ultrasound to determine the true functioning of her heart. She would then become a pet; in fact, she was already spoken for. She didn’t have a name so we called her SmallZee.

Right away there was the problem with wetting. Naturally you expect a dog to have accidents but this dog was something else! It got to the point where we started wondering if there was a medical condition so we began recording her activity. Our records for the second night (bearing in mind that we pulled her water at 6PM) show wetting and/or “dumps” at 10:30 pm; 1130 pm; 1:00 am; 2:30 am 4:30 am; 7:15 am; 8:30 am; 8:45am; 10:00 am; 11:15 am; 11:50 am; 12:00 n; 1:00 pm; 1:25 pm; 2:00 pm; 2:15 pm; 2:24 pm; 3:05 pm; 3:15 pm; 3:20 pm; 4:30 pm; 4:40 pm; 4:45 pm; 5:00 pm; 5:10 pm; 6:30 pm; 7:45 pm; 8 pm; 9:30 pm; and 10:00pm. I don’t care how many dogs you have had – that is a lot of rain. Even Robbie was impressed. Robbie suggested that we bring her down to the kennel and she would put her in a room covered with newspapers to see how much water there actually was based on the size of the wet spots. I suggested that if it was a small room SmallZee would soon be doing the dogpaddle. In addition to the wetting, she excreted more than she weighed – certainly more than she ate.

Like most puppies, she was intrigued by the electric cords to the television and the telephone and those little knobs that sit on the bolts holding the toilet to the floor. Of course, she also got into the paper. She chewed our step stool so we put it on top of the crate. We also kept a coat on top of the crate, ready for emergency service. SmallZee pulled the coat off the crate and the stool along with it, breaking the handle. We like to hang dish towels over the edge of drawers to dry. She is the only dog we ever had that pulled them off, whipping them about as she ran past you.

We taught her to go up and down stairs. She got the “up” part pretty quickly but “down” was a bit scarier because she didn’t have full control over her legs. Her back legs were wobbly and would sometimes veer sideways when she moved. After a while, with treats, she overcame her fear and then she became relatively brave. Sometimes in the snow, she would outrun her front legs and go down with a “whoof” and slide on her chin in the snow.

She took to barking, high little ear-penetrating yips. She would tear across the kitchen floor and go under the table and stop which immediately caused concern. Sometimes she would bark to get you to play with her, sometimes making a running leap to get into your lap. If you were on the floor scratching her ears, she would make several strikes at your nose to take it off your face.

She seemed to be a happy dog – delighting in her toys and meeting people.   Her tail was always wagging. She loved her plastic milk carton, working patiently to maneuver it into her crate. She loved peanut butter in a bone.

 

On March 10, SmallZee went in for her ultrasound to get a final diagnosis on her heart. We expected to pick her up after 4 PM. Our understanding was that we would keep her for a few more days and then pass her on to her permanent owner. Sometime during the afternoon, Robbie called. They were putting SmallZee to sleep. Her heart had too many malfunctions.

We have been associated with the guide dog organization for a number of years and this news was by far the saddest moment we have experienced. We quietly picked up the stuffed dog that SmallZee  had brought home from the kennel. We cleaned the small crate, and collected the toys and the leash that she would chew on, oblivious to the hot sauce we had soaked it in. We took down the gates and picked up the water bowl. We washed her food dish and put it away. Then a profound sadness settled over us. Her “bad” moments were set aside, replaced by memories of the funny things she did, the way she was startled when I barked back at her, methodically taking the toys out of her Rubbermaid box and then climbing in it and going to sleep, the way she annoyed Linda by grabbing on to her pant cuffs when she walked. We were unaware that she had worked her way into our hearts. Now she is gone, not to another master, but really gone. She never did get to do what she was bred for. She never even got to play with other puppies after she left the kennel. We won’t see her again. Somehow there is a difference between not seeing her again because she is guiding or being a pet and not seeing her again because she is dead. I hope she had some fun with us. We loved her.

 

Coming Drug Disaster

Drug companies are pushing through Congress a new law that would be “…  a give-away to the pharmaceutical industry, removing many of the safety mechanisms in place that are supposed to keep the public protected from unsafe drugs and medical devices.

Source

“The 21st Century Cures Act” Is On Its Way – Here’s Why You Haven’t Heard About It

money

The 21st Century Cures Act is going through the U.S. Congress right now, and it will likely pass into law unless some opposition materializes (it passed through the House of Representatives Energy and Commerce Committee with a vote of 51 to 0).  The Act is a give-away to the pharmaceutical industry, removing many of the safety mechanisms in place that are supposed to keep the public protected from unsafe drugs and medical devices.

The 21st Century Cures Act allows drugs to be rushed to the market, removes phase 3 testing as a requirement for drug approval, bases drug approval on biomarkers rather than actual health outcomes, and encourages the production of new antibiotics at a time when microbiome destruction is increasingly being linked to chronic diseases.

Rushing Drugs to Market

With the passage of the 21st Century Cures Act, drugs will be rushed to market with little testing required. A New York Times piece, “Don’t Weaken the F.D.A.’s Drug Approval Process” notes that the 21st Century Cures Act “could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death.” The Act weakens an already weak regulatory process that is currently doing a poor job of protecting the public from adverse reactions to drugs and medical devices. (In the currently weak system, preventable medical errors in hospitals are the third leading cause of death in the United States, and, “between 210,000 and 440,000 patients each year who go to the hospital for care suffer some type of preventable harm that contributes to their death.” source)

The End of Evidence Based Medicine

Modern medicine is supposed to be “evidence based medicine” backed up by replicable, placebo controlled scientific experiments that show that a drug or medical device effectively treats the disease or symptom that it is purported to treat. This standard of evidence will no longer exist if the 21st Century Cures Act passes into law. The Act will allow drug approval to be based on biomarkers and surrogate measures rather than health outcomes. This has been disastrous in the past and it will be even more disastrous in the future. For example, we’re now seeing that statins do well at reducing cholesterol, but despite improving that biomarker, they don’t improve health outcomes for large portions of the population (notably, the female portion of the population).

A New England Journal of Medicine (NEJM) article, “The 21st Century Cures Act — Will It Take Us Back in Time?” notes that:

But though a drug’s effect on a biomarker can make approval quicker and less costly, especially if the comparator is placebo, it may not always predict the drug’s capacity to improve patient outcomes. Bevacizumab (Avastin) delayed tumor progression in advanced breast cancer but was shown not to benefit patients. Similarly, rosiglitazone (Avandia) lowered glycated hemoglobin levels in patients with diabetes even as it increased their risk of myocardial infarction. In 2013, patients began to receive a new drug for tuberculosis approved on the basis of a randomized trial relying on a surrogate measure of bacterial counts in the sputum — even though patients given the drug in that trial had a death rate four times that in the comparison group, mostly from tuberculosis.

Representative Diana DeGette (D-CO), one of the co-sponsors of the 21st Century Cures Act, bragged on Twitter that, “In 120yrs we have gone from #snakeoil to mapping the #humangenome. W/your help #Cures2015 is ready to take us further.”  But if pharmaceuticals are no longer required to have evidence that they improve health outcomes, how are they any better than snake oils? One only needs to look as far as the recent history of psychiatry to see that the line between snake oils and “evidence based medicine” is already woefully thin.  Removing regulatory and procedural requirements from the drug approval process, via the 21st Century Cures Act, will just encourage the production of more dangerous pharmaceuticals that are no better or safer than snake oil.

Diminishing requirements for evidence of efficacy is bad for the medical system too. Basing medicine on scientific inquiry and actual evidence of efficacy is a bedrock of medicine, and without it the medical system will lose credibility.

The Loss of Informed Consent

The 21st Century Cures Act will diminish another bedrock of modern medicine – informed consentThe NEJM articlenotes that:

“Informed consent by patients in drug trials has traditionally been sacrosanct, with exceptions made only when consent is impossible to obtain or contrary to a patient’s best interests. But another clause in the proposed law adds a new kind of exception: studies in which ‘the proposed clinical testing poses no more than minimal risk’ — a major departure from current human subject protections. It is not clear who gets to determine whether a given trial of a new drug poses ‘minimal risk.’”

Informed consent is crucial not only for the credibility of modern medicine, it is crucial for liberty.

Dangerous New Antibiotics

One of the least controversial, but in reality most dangerous, parts of the 21st Century Cures Act is its encouragement of new antibiotics. Before I go into why this part of the Act is dangerous, let me acknowledge that bacterial resistance to antibiotics is a huge problem, and antibiotic resistant infections are causing many deaths. Without being able to keep pathogenic bacteria in check, many medical procedures will be impossible, and many lives will be lost.  But we got into the predicament of bacteria being resistant to antibiotics by over-using antibiotics in both agriculture and medicine, and to encourage increased use of antibiotics will only perpetuate the problem. The solution to antibiotic resistance is prudent use of available antibiotics and finding sustainable ways to reduce harm caused by pathogenic bacteria (perhaps by using healthy bacteria to keep the unhealthy bacteria in check), not doubling down on the “kill all bacteria” tactic that led us to the problem of antibiotic resistant bacterial infections in the first place. Bacteria will continue to adapt in us and around us, and increasing the intensity of the war between us and bacteria is beyond foolish.  We will lose any war that we wage against bacteria because we need bacteria – they are not separate from us – and they play a larger role in human health than we can currently imagine.

A healthy and balanced microbiome (“the ecological community of commensal, symbiotic and pathogenic microorganisms that literally share our body space”) is crucial for all areas of health, and a disturbed microbiome has been linked to all of the diseases of modernity, including mental health disorders, neurodegenerative diseases like Parkinson’s and Alzheimer’s, autoimmune diseases, inflammatory bowel disease and Crohn’s disease, mysterious diseases like fibromyalgia, autism, etc. And while there is acknowledgement of the role that a healthy microbiome plays in these diseases, researchers and journalists alike have been loath to acknowledge the role antibiotics have played in contributing to these diseases of modernity. No one wants to be anti-antibiotic. Everyone knows that antibiotics have saved millions of lives, but that doesn’t mean they are without consequences. And the good that penicillin has done doesn’t mean that all antibiotics are equally safe or effective. I can make a pretty thorough argument that fluoroquinolone antibiotics, like Cipro/ciprofloxacin and Levaquin/levofloxacin, drugs that work by “inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination,” are at least partially responsible for many of the diseases of modernity (more information can be found HERE, HERE andHERE). Fluoroquinolone antibiotics do not have the same safety profile as amoxicillin, and to assume that they do because both are categorized as antibiotics, is foolish on multiple levels.

The 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. Doctors Avorn and Kesselhem note in the NEJM that:

The proposed legislation would make immediate changes with respect to new antibiotics and antifungals by enabling their approval without conventional clinical trials, if needed to treat a “serious or life-threatening infection” in patients with an “unmet medical need.” In place of proof that the antimicrobial actually decreases morbidity or mortality, the FDA would be empowered to accept nontraditional efficacy measures drawn from small studies as well as “preclinical, pharmacologic, or pathophysiologic evidence; nonclinical susceptibility and pharmacokinetic data, data from phase 2 clinical trials; and such other confirmatory evidence as the secretary [of health and human services] determines appropriate to approve the drug.” Antimicrobials approved in this manner would carry disclaimers on their labeling, but there is no evidence that such a precaution would restrict prescribing to only the most appropriate patients. If passed in its current form, the bill would also provide hospitals with a financial bonus for administering costly new but unproven antibiotics, which could encourage their more widespread use. The bill gives the secretary of health and human services the authority to expand this nontraditional approval pathway to other drug categories as well, if “the public health would benefit from expansion.”

Fluoroquinolone antibiotics like Cipro and Levaquin, some of the most popular antibiotics on the market, cause a chronic illness known as fluoroquinolone toxicity syndrome or, colloquially, “floxing,” that includes damage to connective tissue (tendons, ligaments, cartilage, fascia, etc.) throughout the body, damage to the nervous systems (central, peripheral, and autonomic), and more. Rather than putting mechanisms in place that help victims of iatrogenic antibiotic poisoning, or to prevent their pain and suffering in the first place, the 21st Century Cures Act opens the door for more damaging antibiotics to flood the market.

The Ever-Increasing Power of the Pharmaceutical Industry

The current medical system lacks the mechanisms required to protect consumers from the dangers of pharmaceuticals. The FDA is failing to protect people from dangerous drugs, the justice system is failing to compensate people for harm done by dangerous drugs, doctors, pharmacists and even research scientists are so indoctrinated in the “there’s a pill for that” culture that they fail to question it, and the drug-consuming public ends up poisoned and sick because no one is keeping the pharmaceutical companies in check. All powerful entities need checks and balances, the pharmaceutical industry is no exception.  The 21st Century Cures Act gives the too-powerful pharmaceutical industry even more power, power that will undoubtedly be abused.

Pros and Cons

There are a couple good elements to the 21st Century Cures Act. It increases the NIH budget, which some can argue is an improvement. It also focuses on finding pharmaceutical solutions to rare diseases, which many people with rare diseases will find to be cause for hope.

I fear though, that people with rare diseases will be turned into guinea pigs because the pharmaceutical companies seeking cures for their rare diseases will have no limits put on what they can do to the people suffering from them.  I also find it objectionable that there is no mention in the Act of investigating the causes of “rare” diseases or “rare” adverse drug reactions.

The potential harm that can be brought on by the 21st Century Cures Act far outweighs its potential benefits, and I encourage all Americans reading this to contact your Congressional Representatives to voice your concerns about this bill.

Human Health is Too Important to Leave to Congress 

The human body is amazingly, beautifully, mind-bogglingly complex and intricate. New discoveries about our biology are being made every day. For example, it was recently discovered that the brain has a lymphatic system, a discovery that may have huge implications for human health. Additionally, the burgeoning fields of epigenetics andmicrobiome research have far more questions than answers within them, and exciting discoveries are being made within those fields every day. Though there are undoubtedly brilliant scientists working in the biological sciences, even they are far from knowing “enough” about unforeseen consequences of messing with a biological system (through use of a drug) that connects to all other biological systems.  Any doctor or scientist who is worth his/her title realizes how little anyone knows about the complex workings of the human body, is aware that medicine is constantly changing as new discoveries are made, and has humility about the consequences of what he/she doesn’t yet know.

If scientists can’t possibly know “enough” about human biology to produce pharmaceuticals that are exact and without side-effects (aka collateral damage), the shills and corporate-whores in Congress certainly don’t know “enough” about human health to legislate major changes that affect how medicine is implemented. They have that power though, and the 21st Century Cures Act is a consequential piece of legislation that is going to have major effects on the entire medical system if it is signed into law. Most of those effects are negative.

The 21st Century Cures Act diminishes the rocks on which modern medicine are based – informed consent, individual body autonomy, the Hippocratic Oath, and basing medicine on scientific evidence. The people of America, and the world, need to fight to keep those bedrocks in place. If all medical decisions, and all medical legislation, were made with informed consent, individual body autonomy, the Hippocratic Oath, and scientific evidence in mind, the world would be a much better place. Don’t assume for a second that current medical and legislative decisions are being made with those basic principles in mind. They are constantly being eroded.  Diligently protect them to the best of your ability – and call your Representatives.

Resources:

  1. New York Times, “Don’t Weaken the F.D.A.’s Drug Approval Process
  2. The New England Journal of Medicine, “The 21st Century Cures Act — Will It Take Us Back in Time?
  3. Medscape Medical News, “Bill Aims to Expand Drug Indications Minus Randomized Trials
  4. Modern Healthcare, “Beware a 21st Century Quackery Act
  5. Public Citizen, “Cures for the 21st Century: Five Simple Ideas Congress Has Ignored

 

Supreme Court Surprises

In the  past, the 4 “liberal” justices on the Supreme Court have lost decisions to the 5 “conservative” justices.  In the session just ended, one or another conservative has joined the liberals to decide important issues. In this piece,  As always, Nina Totenberg brings the court to life in this piece, Totenberg brings the court to life with the legal arguments and judicial personalities that set the law of the land.  She reports frequently for NPR when the court is in session.    rjn

Liberal Minority Won Over Conservatives In Historic Supreme Court Term

An American flag flies over the U.S. Supreme Court June 29, 2015 in Washington, D.C. This past term, the liberal position won in 19 of the 26 closely-divided ideological cases and eight out of 10 of the most important ones.  Mark Wilson/Getty Images

It was a historic term, a surprisingly liberal term — and a nasty term.

That’s the essence of the tea-leaf reading about the U.S. Supreme Court term that just concluded. Astonishingly — though the court is dominated by conservative justices — the liberal minority, disciplined and united, drove the direction in a startling number of cases, while the conservatives splintered into multiple factions.

The numbers tell the story. The liberals won in 19 of the 26 closely-divided ideological cases and eight out of 10 of the most important ones. Those numbers were compiled by SCOTUSblog, the go-to Supreme Court online journal.

“This is, by the numbers, the best term for the left in at least a quarter century,” observes publisher Tom Goldstein.

Time after time, the liberals stuck together and managed to win over one or more conservatives — as they did in the case holding that states may refuse to issue Confederate flag specialty license plates. In that case, the court’s most conservative justice, Clarence Thomas, joined the liberal four, providing the fifth and decisive vote.

Goldstein says that even taking the most centrist of the conservatives, Justice Anthony Kennedy, out of the equation, one or more members of the conservative bloc crossed over to join the liberals in 14 of the most ideological cases, while the reverse was true for the liberals only three times.

But as Goldstein observes, the liberals are, for the most part, just trying to preserve the status quo.

“A lot of what’s going on with the left is that it’s much easier to stick together on defense, when you’re not calling plays and going for bombs and slants and trying to make a big difference and change the law,” he says.

Court watchers cite other reasons for the liberal success this year — among them, that conservative activists just pushed their agenda too far.

“Several of the most important [liberal] victories that you see, are simply the court blinking at the extremism of certain [conservative] claims that were being put before it,” says Yale Law School’s Akhil Amar.

Another explanation is that the five conservative justices on the court have very different legal philosophies, and the cases this term showed those splits in vivid color. In all, the court’s four most conservative justices wrote 78 dissents and concurrences, versus only 27 for the liberals.

Supreme Court advocate Walter Dellinger says the split among the conservatives is between “ideological, professorial conservatives” — Clarence Thomas, Samuel Alito, Antonin Scalia — and John Roberts and Anthony Kennedy, “who are more economic conservatives, which makes them more pragmatic and more realistic about what works.”

Dellinger adds that 3-2 split “in some ways reflects the split within the larger Republican Party politically.”

Or as Amar puts it, “The Reagan coalition is beginning to fray as the world turns, time passes, new issues arise.”

The outcomes this term were so much of a turnaround that the liberal justices looked positively serene, even perky, in June, while the tone of the conservative dissents was unusually harsh.

“The bombastic tone of the dissents this term was over the top, even for Justice Scalia, who has a blood-soaked pen at his desk,” Goldstein says.

“He wrote the nastiest thing I have read in any Supreme Court opinion,” says Charles Fried, who served as the government’s chief advocate in the Supreme Court during the Reagan administration.

Dellinger, who had the same job in the Clinton Administration, agrees.

“I’ve never seen that kind of really, deeply personal attack that basically says ‘The author of the opinion is not just wrong as a matter of law, he’s a jerk,’ ” says Dellinger.

That’s pretty much what Justice Scalia wrote about Justice Kennedy’s soaring rhetoric in the same-sex marriage case, calling it “pretentious,” and “egotistic,” and comparing it to “the mystical aphorisms of a fortune cookie.” If I had ever joined such a vague opinion, said Scalia, “even as the price to be paid for a fifth vote, …. I would hide my head in a bag.”

Fried, now a professor at Harvard Law School, says that in some ways, Kennedy’s opinion provoked that reaction. He says that Kennedy should have focused on legal precedents instead of poetic passages. In particular, the court’s 1967 decision striking down state bans on interracial marriage, and two more recent decisions dealing with same-sex relations and marriage.

Those three court precedents dictated the result, Fried maintains, adding, “That is the law. Suck it up!”

Even those who don’t like the way the decision was written, however, see it as historic. The kind of decision that comes along only once in a half century.

Amar likens it to Brown v. Board of Education barring segregated public schools, though he points to critical differences. This time, he says the court was not leading the charge.

“It was just riding the wave, keeping up with the tide,” he says.

In contrast he says the court in Brown was actually ahead of its time.

“Brown in 1954 comes along, before Martin [Luther] King [Jr.] appears on the scene, before a massive civil rights movement. So Brown actually starts the political avalanche,” whereas “this time the court is actually following the lead of activists” and rapidly changing public opinion.

The court’s other major decision at the end of the term upheld nationwide subsidies in the Affordable Care Act. And as Dellinger observes, Chief Justice John Roberts’ opinion for a 6 to 3 majority was “surprisingly favorable” to the law.

“The first five pages of the chief justice’s opinion … is the best articulation of the case for the Affordable Care Act anybody has written,” Dellinger says.

The decision did something else important. It sided with the liberal view that legislation should be interpreted in terms of its overall purpose and not by flyspecking a phrase here and there. And it said that the judiciary, not executive agencies, has the last word on such interpretations.

This was Roberts’ 10th year as chief justice, and this term he proved to be something of the justice he said he would be at his confirmation hearings: restrained and deferential to legislative bodies where possible.

“In both the Affordable Care Act case and the same-sex marriage case, John Roberts was the only justice who took the minimalist position,” says Supreme Court advocate Dellinger, now professor emeritus at Duke Law School. “He neither inserted himself in the Affordable Care Act process by derailing it, as his conservative colleagues would have done, and he didn’t take the judicially ambitious stance, correct in my view, of invalidating the same-sex marriage position of all the states.”

Indeed, observes Dellinger, Roberts was the only justice of the nine who took that minimalist position in both of these cases.

Roberts has not always demonstrated such a hands-off or deferential approach. He wrote the 2013 decision striking down the key provision of the Voting Rights Act, a law Congress had enacted and re-enacted by overwhelming votes. And he has repeatedly joined and written decisions striking down most of the laws that regulate money in election campaigns.

In short, just because the liberals happened to win a lot this year, doesn’t mean they will in the future.

“There are liberal terms, there are conservative terms, and it largely depends upon what the case mix is,” observes Stanford Law professor Michael McConnell.

Indeed, next term the court has accepted a mix in the heartland of a conservative legal agenda — cases that seek to overturn or cut back past Supreme Court rulings on abortion, affirmative action and labor union rights.

Illinois Bison Herd Grows

 

ILLINOIS BISON BUSY AS RABBITS
14 calves born this spring on restored stretch of prair
By Ted Gregory Chicago Tribune     July 3, 2015
VISITING  Nachusa Grasslands
Bison calves lie in tall grass near their mothers Wednesday at the Nachusa Grasslands in Franklin Grove, Ill.   ANTHONY SOUFFLE/CHICAGO TRIBUNE 
 Since wild bison were reintroduced to an Illinois prairie after being absent from the region for nearly two centuries, the animals have been multiplying a bit like another more prevalent prairie mammal: rabbits.   A total of 14 bison calves were born this past spring at Nachusa Grasslands, a prairie restoration project about 95 miles west of Chicago that is fostering the relationship between two fledgling entities — Illinois’ prairies and the iconic animals that help sustain them.
The most recent calf was born Wednesday.   “They’re doing well,” Nachusa project director Bill Kleiman said of the herd, which has 43 members. “They look just like they belong, which they do.”   The births are an obvious, promising outgrowth of the bison’s return to the area east of the Mississippi River.
And there are other encouraging signs.   Researchers have found, for example, that smaller mammals , including mice and voles, are building nests of bison hair, said Nachusa restoration ecologist Cody Considine. He also has noticed swallows hovering over the bison herd, feeding on insects attracted to the bison.   These developments suggest healthier, growing animal and insect populations, which are expected to attract a wider array of species to Nachusa.
Species diversity is a key reason the bison were brought to the 3,500-acre grasslands owned by The Nature Conservancy.   Apart from ecosystem benefits, the bison charm and inspire people, said the conservancy’s Illinois director, Michelle Carr.   The conservancy had been promoting the return of bison to Nachusa for years, which created “pent-up, emotional support,” Carr added. Since the animals’ arrival, the number of donations has increased 50 percent, she said, enough to fund almost all of the $1.3 million effort to bring the animals to Nachusa and prepare the prairie for them.  
Image result for bison calf photosMore bison calf photos.
 The conservancy began acquiring land in the area in 1986 with the goal of creating a vast prairie in a state that had lost nearly all of that native landscape. The national organization has an active team of volunteers and staff at Nachusa who have conducted more than 105 prairie restorations there and gathered thousands of pounds of seeds to plant more native prairie species.   Those seeds will have a better chance of thriving in the presence of bison. Researchers have noticed that the animals, as expected, are eating almost exclusively non-native grasses, which allows native plants to take over the landscape.  
Bison disappeared from Illinois and much of the land east of the Mississippi in the 1830s, victims of hunting and mass slaughter that nearly wiped out the population throughout the U.S. Conservation efforts that began in the 1900s brought the numbers back   — current estimates hover around 450,000 — and a few populations sprouted in Illinois and elsewhere in the region before the Nachusa herd arrived by truck in October from Broken Kettle Grasslands near Sioux City, Iowa. 
  But the newcomers possess several traits that distinguish them from bison already here.   The Nachusa bison have not been interbred with other species, namely cattle, and are genetically diverse within the bison species. They also are direct descendants of the original herd saved from extinction and are touched by human hands only once a year for about a minute during a veterinary checkup.  
The bison are viewed by human eyes more often, Considine and Kleiman said. Although Nachusa doesn’t track precise figures, Considine said the number of visitors to Nachusa has climbed “tenfold” since the bison arrived. After the first calf was born in April, “people have been going crazy about” them, he said.   Motorists stop him three or four times a day to ask where the bison are, he said, but it’s a tough question to answer.
The 500 acres the animals roam are closed to the public. Some days the bison wander next to the fence along two roads, making for easy viewing. Other days, the animals roam deep into the prairie, out of sight from the road.
   Considine is “swamped with giving tours” to interested groups and individuals, he said. Recent visitors have included the AudubonSociety, Sierra Club and a staffer from the office of U.S. Rep. Adam Kinzinger, an Ottawa Republican. Considine said.
In addition, Considine has met visitors from Spain and France who took time from their trips to Chicago to drive out to see the bison, he said.  
The next step at Nachusa is to expand the prairie where the bison roam. Workers are building fences around an additional 1,000 acres, which is expected to be complete in October, Kleiman said.   Staff also is planning an “observation station” that would make Nachusa more accommodating to visitors, Kleiman added. That project is scheduled to be finished in spring.
In addition, Considine said the staff is working on establishing a schedule for tours.  
A dozen bison are expected to arrive this fall from Wind Cave National Park in South Dakota, part of a tentative, five-year plan calling for 100 to 150 bison at Nachusa, Considine said. The Nature Conservancy will sell some bison to, and swap them with, other conservation herds.   The objective is to strengthen the healthy synergy between bison and prairie.   “As exceptional as bison are as conservationists,” said the conservancy’s Carr, “they also are incredible ambassadors for the prairie.”tgregory@tribupub.com