It is refreshing to know that there are reputable people working at the FDA. The Vioxx whistleblower was one. Susan Wood, director of FDA’s Office of Women’s Health, is another. Unfortunately, she has resigned over the FDA’s decision to be indecisive. Yes, it’s Plan B again, better known as emergency contraception or the morning after pill. Wood just got so fed up that she quit.

CNN published the email that she sent to her colleagues at the FDA, and which was released by contraception advocates.

“I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” wrote Wood, who also was assistant commissioner for women’s health. “The recent decision announced by the Commissioner about emergency contraception, which continues to limit women’s access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women’s health.”

Not only has the FDA caved into political pressure from our merry band of neocons, but they have proven themselves to be liars. Case in point: Lester Crawford, now the pathetic commissioner, finally broke the stalemate in the Senate regarding his confirmation only after promising members of Congress to make a final decision by September 1. And guess what? No decision. Or I take that back–the fool made the grand decision not to make a decision. In other words, he lied in order to be confirmed. Nice going, Lester. It’s comforting to have guys like you playing around with our food and drugs.

As of 12:15 P.M., New Orleans local time, word from the Army Corps of Engineers is this: 1,200 sandbags that are 20,000 pounds each are being brought in to bridge gap…water level is no longer rising.

If the water is no longer rising, it means that the flooding will be stabilized, and they can start working on pumping it out. It’s so hard to pick out and find the good news, as most media just loves to focus on the negative and milk it for all it’s worth. Reading some of the reports, one would think that New Orleans was completely submerged, just like the lost city of Atlantis. There is SOME flooding in about 80% of the city, but the important word here is some. While there is extreme flooding that reaches rooftops, some of it is only ankle high or less. The French Quarter is relatively dry.

This is not to make light of the damage, but it does seem that a number of the articles flying off the press are intentionally worded to make the damage and situation more catastrophic than it actually is. And most of the coverage does seem to be focused on New Orleans. Understandably, it is a major US city, much beloved, historic, and a huge tourist attraction. But in reality, the worst damage was in Mississippi, in the Biloxi-Gulfport region. The area looks much like the pictures and videos of the areas that the tsunami hit back in December in Asia. I guess, though, that reporting on Mississippi isn’t as exciting as New Orleans, and in many reports, it often seems as an after thought.

Katrina swerved at the last minute, and did not make a direct hit on New Orleans. She did make a direct hit on the Gulf coast of Mississippi, with sea surges over 20 feet (highest reported is 28 feet although I’ve seen varying numbers), and in some places, the surges reaches 6 miles inland. So do the math and connect the dots.

There are some great resources for people who are trying to get updates on the hurricane damage, or information about family, friends, or their own homes. Here’s a few links that you may find useful:

New Orleans station WWL TV has a bulletin board where you can ask or answer questions about missing people, towns that were unfortunate enough to be in Katrina’s path, etc.

WWL TV has a Katrina Blog, with updates as they come in. And I really mean as soon as they arrive–the blog is updated every few minutes.

Weather.com has a Katrina Information Board up and running, where you can post questions and answers.

He who gets the most patents wins. Biotech monster firms are trying to patent everything from pigs (yes, I wrote about that already), seeds, traditional therapies which have been in use for thousands of years, body parts, and now rice. Rice.

Strange but true. The Swiss biotech corporation Syngenta has dreams of owning every rice paddy from California to Vietnam. Every little rice shoot will bear their name, and they will collect payment on every seed used to grow the little critters. Considering how much rice is consumed in Asia and elsewhere–well, the fortune to be earned is beyond comprehension.

Syngenta has filed patent applications on much of the genetic material found in thousands of varieties of rice, the staple crop of more than half of the world’s population. Syngenta is also attempting to patent the use of rice in plant and animal feed. “With these patents Syngenta is claiming the work of breeders and farmers from the past centuries as the company’s own invention. The attempt to monopolize thousands of gene sequences from most important crop plants in one rush is nothing less than a theft of common goods,” says Tina Goethe from Swissaid.

Cool. Don’t you just love these people? according to Syngenta patent experts, they are trying to claim as their own all gene sequences that could be of commercial interest. Cute. And by claiming this genetic information as their own, they may well achieve their aim of monopolizing all similar gene sequences in any other useful plants, enabling Syngenta and other companies to determine prices and access to all kinds of seeds.

In other words, control of the world’s food supply. Every time you take a bite, you drop a dollar or two into the gaping pockets of companies like Syngenta and Monsanto.

Read the entire article.

At this very moment, category 5 hurricane Katrina is taking aim at New Orleans, a wonderful city located in a very precarious spot. With 70% of the city below sea level, and surrounded on three sides by water, New Orleans is an accident waiting to happen. To say nothing of its location in a region prone to violent storms.

This season is predicted to be the most active yet, as far as hurricanes and tropical storms ago. Still only August, and there’s already been 3 major hurricanes. And we are already up to “K.” I believe that thus far, 1995 holds the record, when we actually reached the letter R–and lo and behold, a demon of hurricane named Roxanne (named for me no doubt) soaked Texas and created havoc.

Anyway, let’s hope and pray that New Orleans is able to tough this one out, and that the Big Easy will still be here come morning.

You just gotta love ‘em. Now, after over 2 years of debating (28 months to be exact) and receiving the nearly unanimous blessing of their advisory committee, the FDA has reached a decision on whether or not to make the morning after pill available over the counter. The verdict? Okay, get the ammonia capsules ready.

Our hallowed Food and Drug Administration hs announced that they have “indefinitely postponed its ruling” on whether women should be allowed to buy the “morning-after pill” Plan B without a prescription–despite assurances that it would act by Sept. 1.

The decision to embark instead on a new regulation-writing process was denounced by women’s health advocates and some lawmakers as a stalling tactic. A formal rulemaking generally takes years to finish.

“What we’re saying today is that there are unique regulatory issues here that need to be addressed before we can make a decision on this application,” he said, adding he could not estimate how long that might take.

It is really a shame that the FDA has transformed into such a sad joke, and that they are caving in to pressure from fanatical neocons–who quite obviously, prefer to see fetuses aborted rather than pregnancy prevented. But why should anyone be surprised? A few days ago I posted on how a biotech insider, one who advised investors, has landed a spot as a deputy commissioner. And now today, the FDA just can’t bring itself to to the right thing, the job that it was created for, and confirm that the morning after pill be made available over the counter.

The FDA, throughout its history, has always maintained an ultra-cozy relationship with the industries that it is supposed to be regulating. But now, it seems to be completely forgetting science, and is wimping out under political pressure.

Nice going, FDA. I’m so proud that you are looking after the health and welfare of the American people. It just makes me feel so safe!!!

Now, let me and puke.

Read the entire article on the Chicago Tribune.

I think I’m still decompressing–I know, I need the vacation from a vacation. But I guess that I didn’t sleep very much while traveling (strange how you need less sleep when out having fun) but now it is catching up. I’ve also got a lot going on aside from work, like trying to clear out clutter once and for all, decide where I want to live when I grow up, and stuff like that.

So hopefully, I will post tomorrow. I’ve got a lot of plans for the blog, including putting in more links, holding a weekly “grand rounds,” adding in reference material on different health subjects, and so on.

It is amazing that no paper, other than the Seattle Times, happened to take the initiative and point out Scott Gottlieb’s ties to the biotech industry. I have spent a little time searching the web, and nothing at all comes up. There may be other newspapers who did write on it, of course, but what I can say is that there is a considerable dearth of good reporting. Even a Reuter’s story just mentions Gottlieb as a “former AEI scholar.” Was the media just too lazy to go beyond the press release from the FDA?

Scott Gottlieb, MD, a former FDA and Centers for Medicare and Medicaid Services senior official, is returning as FDA’s new Deputy Commissioner for Medical and Scientific Affairs. In this position, Dr. Gottlieb will coordinate medical and scientific affairs for the Office of the Commissioner serving as senior policy advisor to the Commissioner in these areas. Dr. Gottlieb is a practicing physician who most recently worked as a Resident Fellow at the American Enterprise Institute (AEI), a prominent Washington, DC-based think tank and also spent time as an American medical correspondent for the British Medical Journal.

That is from the official FDA press release of July 29, 2005, annoucing new appointments. It took the Seattle Times almost a month to report that this new appointee has a questionable background (for someone who is supposed to be regulating the industry) but at least they ran the story. In fact, it was on the front page, to their credit. So where is everyone else? And why did the FDA’s official release conveniently omit Scotty’s career in biotech investing? I mean, if there’s no conflict of interest, then why not mention it? Surely it’s nothing to be ashamed of.

If you think the FDA hasn’t sunk to its lowest level yet, think again. With all of the heightened concern about conflict of interest, “experts” being paid to parrot corporate rhetoric rather than real science, and unsafe drugs slipping past the FDA’s pretense at regulation (while they stall and kick the dust around on emergency contraception), our hallowed FDA has hired Dr. Scott Gottlieb as a dputy commissioner.

Perhaps you aren’t gagging yet because you don’t know who Dr. Gottlieb is. Well, I’ll tell you. From the Seattle Times:

Until last month, Gottlieb was editor of a popular biotechnology investor newsletter, Forbes / Gottlieb Medical Technology Investor. Forbes touted Gottlieb’s stock-picking success on its Web site in mid-May–”Special Offer: In the last few months, Dr. Scott Gottlieb recommended two cancer cure stocks to subscribers that have already climbed 38 percent. Click here for the latest report from Forbes / Gottlieb Medical Technology Investor, ‘Three Biotech Stocks To Buy Now.’”

In his new job, Gottlieb will help oversee such major policies as the FDA’s fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry. Isn’t that a cozy relationship? Is this the only person that the FDA could have found for the job?

Gottlieb says that he “cut” his ties and doesn’t think there’s a conflict of interest. Isn’t that sweet. What a guy. And here’s some of the new and great ideas that Scott brings to the FDA. comes to the FDA with an agenda. He wants to speed up drug approvals, which can be a good or bad thing, depending on what you mean by speeding it up. But in Scotty’s case, I think his concern is more for the investor and the drug company, rather than getting an essential drug safely and quickly to the consumer.

Here’s the clinicher though. Scotty also thinks that “the FDA sends out too many “shotgun warnings” on any particular drug’s emerging side effects, which he said may cause patients to overreact.” My, my, imagine that. Imagine how many people might still be alive if more attention had been paid to the early warnings about Vioxx.

When the FDA announced Gottlieb’s hiring last month, it noted that he had been a practicing physician, a correspondent for the British Medical Journal, and a scholar at the American Enterprise Institute (a conservative think tank)But if there’s no question about conflict of interest, then why did they conveniently not mention his career as editor of the two popular biotech investment newsletters or his work with Wall Street firms.

This whole thing reeks, as does Gottlieb now trying to portray himself as a squeaky clean physician without any industry ties. Just when you think that the FDA can’t sink any lower, and make even a bigger fool of itself.

No, the title is not a typo. You read it right. Monsanto wishes to control the entire food supply (and water supply) of planet Earth, and they are doing their best to achieve that. Unfortunately, many farmers are dissatisfied with their franken seeds and the company’s brutish tactics, so world domination of agriculture has not gone according to plan.

So what next? Pigs.

Monsanto has filed patents in 160 nations for… pigs. The World Intellectual Property Organization in Geneva recently published the patent requests, which has left the pork industry squealing with contention. If approved, Monsanto would gain ownership of certain types of breeding techniques that are already in common use by farmers around the world. The patents also request Monsanto overtake of ownership of the pigs born of those breeding techniques as well as their related herds. Although controversial, the profit incentive of this legal maneuver for Monsanto is enormous, as annual pork sales in the U.S., alone, are $38 billion annually.

Read the whole article from Reuters. It’s enough to make you, uh, squeal in horror.

I don’t have very much information on this story, other than a brief press release, but it appears that several nurses were suspended for speaking up about staffing woes. If is unclear if they went to the press without first trying to work within their facility, or going through the chain of command, or what.

However, I have heard anecdotally, that nurses have been “ordered” by their facilities never to tell patients that they are short staffed. You know, a big smile on the face and everything hunky-dory. Of course, the patient may be wondering why their medication is 12 hours late, or why they’re sitting in a pool of piss for the past 24 hours and no one has answered their call bell–but the nurse is forbidden to say a thing.

Silver Spring, MD—At a press conference in Lexington Friday, August 12 at 10 a.m. (EDT), United American Nurses (UAN) Secretary-Treasurer Mike Nilsson, RN, Kentucky Nurses Association (KNA) President-elect Pat
Tanner, MPA, BSN, RN, and KNA Executive Director Sharon Eli-Mercer, MSN, RN CNAA BC will bring the message that the Appalachian Regional Healthcare nurses who spoke up for safe staffing should be applauded, not
disciplined.

EC. Emergency contraception. Morning after pill. I thought that this would be resolved already. But lo and behold, when I looked through the news for the first time in weeks, it seems that the FDA is still sitting on their fat ass, hemming and hawing over whether to make EC available over the counter. They still seem to be forgetting that they are supposed to be working for the good of the population–they are not a political organization, are not supposed to be caving in to political pressure or special interest groups, and above all, they are supposed to make their decisions based on science.

I know, I’m dreaming.

Well, the latest is that the FDA will reach a decision by Sept 1st. Should we hold our breath?

Anyway, here is a really good website on EC that is operated by the Office of Population Research at Princeton University and by the Association of Reproductive Health Professionals. Not exactly a band of immoral and ignorant folks on the fringe. The website is designed to provide accurate information about emergency contraception derived from the medical literature, and is really is a treasure chest for anyone looking for the real story.

One exceedingly valuable aspect of this website is that is gives information on where to find provider, state by state in the US, who are willing and qualified to prescribe emergency contraception.

For those of you interested in infectious diseases, and especially, mystery illnesses which plagued populations centuries ago, today is a rather important date in the great annals of health history. On this date in 1485, initial rumors about a strange illness known as “sweating sickness” or “sudor Angelicus,” began to circulate in England.

In the summer of 1485, a rapidly fatal infectious fever struck England. A newe Kynde of sickness came through the whole region, which was so sore, so peynfull, and sharp, that the lyke was never harde of to any mannes rememberance before that tyme.(Don’t you love to read good old-fashioned English??)

English sweating sickness, was characterized by high fever, delirium and high mortality. Patients first suffered from headache, nausea and fever, then broke out within 24 hours into a smelly sweat, labored heartbeat and breathing. Four additional epidemics were reported in the summers of 1508, 1517, 1528, and 1551, after which the disease abruptly disappeared. Chroniclers at the time noted that healthy young males were most often afflicted.

The first outbreak occurred at the end of the Wars of the Roses, which has led some to believe that it may have been brought to England from France, by the French mercenaries which Henry VII used to gain the English throne. The mercenaries seemed to have been immune to the disease. Another interesting fact is that the disease, unless most others at that time, appears to have been more virulent among the rich than the poor. That may be why is was so well documented and outbreaks carefully recorded.

So what exactly is the English sweating disease? Good question, and one that hasn’t yet been figured out. Medical historians have distinguished this epidemic from diseases such as the plague, malaria, and typhus, and have suggested that it may have been a severe form of influenza, food poisoning, an arbovirus, or an enterovirus. Others have speculated whether it was encephalitis, an outbreak of relapsing fever (carried by ticks and lice), or a relative newcomer to the roster–hantavirus (which is carried by rodents).

Only two physicians of the time period provided recorded eyewitness accounts of the outbreaks in England. They were Thomas Forestier and John Caius. Dr. Caius of Gonville Hall, Cambridge, who was president of the Royal College of Physicians, eventually devoted an entire book to the 1551 epidemic, which is the first monograph in English to deal exclusively with one disease. It includes the following vivid description (again, with their delightfully difficult spelling):

First by peine in the backe, or shoulder, peine in the extreme parts, as arme, or legge, with a flusshing, or wind as it semeth to certaine of the patientes, fleing the same. Secondly by the grief in the liver and nigh stomach. Thirdly, by peine in the head, and madness of the same. Fourthly by a passion of the hart . . . it lasteth but one natural day

In modern language, Caius described what many contemporary physicians see as a typical viral prodrome of myalgia and headache, progressing to abdominal pain, vomiting, increasing headache, and delirium. That is then followed by cardiac palpitation, rapid heart rate, and worsening tachypnea with chest pain, prostration, possible paralysis with increasing breathlessness, and ultimately death — sometimes within 12 to 24 hours of the onset of symptoms.

The other physician, Forestier, emphasized “the panting of the breath” and the “difficulty of breathing,” in his writings, suggesting that the lungs were intricately involved in this disease. If it really was a viral pulmonary disease, then its clinical and epidemiologic features seem most closely to resemble those of the hantavirus pulmonary syndrome, which was first recognized in the southwestern United States in May 1993.

But of course, this is all speculation. Unless someone digs up the graves of known victims of the sweating sickness, and does some fancy molecular testing, we will never really know what deadly little germs were responsible for this mystery illness–which vanished nearly as suddenly as it first appeared.

I found this interesting bit of trivia a few months ago, and now seems as good a time as any to post it. There are several interesting facts pertaining to health, such as the education of physicians and that a few of the leading causes of death 100 years ago still haven’t moved off of the list.

What a Difference “A Century Makes”

“THE YEAR 1904″

Where we were a century ago. This ought to boggle your mind.

The year is 1904 , one hundred years ago…

what a difference a century makes..

Here are the U. S. statistics for 1904 ….

The average life expectancy in the US was 47.

Only 14% of the homes in the US had a BATHTUB.

Only 8% of the homes had a TELEPHONE.

A three-minute call from Denver to New York City cost $11.

There were only 8,000 CARS in the US and only 144 miles of paved ROADS.

The maximum speed limit in most cities was 10 mph.

Alabama,

Mississippi, Iowa, and Tennessee were each more heavily

populated than California. With a mere 1.4 million residents, California

was only the 21st most populous state in the Union.

The tallest structure in the world was the Eiffel Tower.

The average wage in the US was $0.22/hour.

The average US worker made between $200-$400/year.

A competent accountant could expect to earn $2000/year,

a dentist $2,500/year, a veterinarian between $1,500-$4,000/year,

and a mechanical engineer about $5,000/year.

More than 95% of all BIRTHS in the US took place at HOME.

90% of all US physicians had NO COLLEGE education. Instead, they

attended medical schools, many of which were condemned in the press

and by the government as “substandard.”

Sugar cost $0.04/pound. Eggs were $0.14/dozen. Coffee cost $0.15/pound.

Most women only washed their HAIR once a month and used BORAX or EGG

YOLKS for shampoo.

Canada passed a law prohibiting POOR people from entering the country

for any reason.

The five leading causes of death in the US were: 1. Pneumonia

&influenza 2. Tuberculosis 3. Diarrhea 4. Heart disease 5. Stroke

The American flag had 45 stars. Arizona, Oklahoma, New Mexico, Hawaii

And Alaska hadn’t been admitted to the Union yet.

The population of Las Vegas, Nevada was 30.

Crossword puzzles, canned beer, and iced tea hadn’t been invented.

There were no Mother’s Day or Father’s Day.

One in ten US adults couldn’t read or write.

Only 6% of all Americans had graduated from HIGH SCHOOL.

Coca Cola contained cocaine.

Marijuana, heroin and morphine were all available over the counter at

corner drugstores. According to one pharmacist, “Heroin clears the

complexion, gives buoyancy to the mind, regulates the stomach and the

bowels, and is, in fact, a perfect guardian of health.”

18% of households in the US had at least one full-time SERVANT or

domestic.

There were only about 230 reported MURDERS in the entire US.

This info comes from LibertyPost.org

Yes, I have returned and the blog will be up and running again. It is strange not to have instant access to email and the Internet, and after the first few days of withdrawal pains, it was kinda nice–in the sense that there really is more to life than sitting in front of my computer. It is good to take a break from things, but I did miss blogging.

So, stay tuned.

Yes, big ideas, like the idea that I was going to catch up on my blog. No such luck. I’m home only for three days, with a pile of work to get done. And then off again for part 2 of my vacation. While I was in Hawaii, it was amazing how many people just didn’t understand the meaning of vacation–that I was not plugged into my email, I was not answering a cell phone, and that I had no intention of doing any work. One of my clients forgot to send me a revision the week before I left, and then thought that I could just take “a quick look” while I was away. Uh, I don’t think so.

It is rather sad how so many of us just cannot disconnect, cannot relax, cannot stand the suspense of going two minutes without checking email or phone messages. No wonder xanax, Prozac and antacids are all best selling drugs.

Anyway, I am leaving again in the am, and will return to blogging on Aug 20. Have a good one!

Hey, I’m back. But alas, too jet lagged and facing a deadline for work that I didn’t complete before I left to do any serious blogging. But I do have some health related anecdotes to share about my vacation (no, I did not suffer from Montezuma’s revenge or any other type of lower GI problem).

Anyway, I will post tomorrow, but I just want you all to know that the blog is still very much alive. I thought I would post while I was away, but my only Internet access was very expensive, and besides, it was really nice to be away from a computer. Once the withdrawal pains disappeared, that is.