Al-Franken Foods

No, these foods probably won't hurt you, but they
may make you die from laughing...

They're called 'medical foods', now the idea of a food (or supplement) that
can help improve your well-being, and even help improve the
symptoms of specific diseases is nothing new, there have been very few
well run clinical trials that have shown cause-relationship, i.e. to put
it more bluntly, there's very little proof that most of them work.
So it may come as a surprise that the FDA has given their tacit approval
to an entire new industry of prescription! 'medical foods'. The big problem here is that while the FDA has given them the appearance of an actual approval in the form of their medical food regulations in reality there is no requirement that these 'medical foods' undergo any safety or efficacy trials that any normal FDA approved drug must undergo.

The FDA is an accessory to misleading the public and giving them a false sense of security by allowing these 'foods' to be distributed through a prescription program. Most people assume that anything prescribed by a doctor and filled by a pharmacy is an approved medication that has undergone clinical trials.

Just because these so called 'medical foods' may be engineered or designer 'foods' rather than naturally occurring foods or substances, does not automatically imply that they are effective at all. Without proof there is no truth.

Shame on the FDA.

Your socialist government at work

Here is a perfect example of the evils of government trying to
decide which companies and/or industries should be supported
instead of letting private industry do what it does best.
This is one of the companies that are getting money via the
"Qualifying Therapeutic Discovery Project Program, established under the Patient Protection and Affordable Care Act of 2010 for projects that showed significant potential to produce new and cost-saving therapies, support jobs and increase U.S. competitiveness":
Hemispherx Biopharma Receives Therapeutic Discovery Project Grant
from U.S. Department of Treasury

Yes folks, a Penny Stock! (50 cents as I write this),
and one with a very long and very unsuccessful history:
(see the history of Ampligen).

Obama IS a socialist.

This article that show precisely why the
government should not get involved in trying to invest in specific
industries or companies:

The NIH's New Drug Discovery Center: Heading Into the Swamp?

As Derek Lowe states:
"I'll make a prediction: if years of effort and billions of dollars thrown after genetic target-based drug discovery hasn't worked out, when done by people strongly motivated to make money off their work, then an NIH center focused on the same stuff will, in all likelihood, add very little more. It's not like they won't stay busy. That sort of work can soak up all the time and money that you can throw at it. And it will."

Sugar Pills Redux

The Wall Street Journal had an excellent
article today on new clinical research that suggests
that policosanol has no effect at all on cholesterol
levels.

http://online.wsj.com/article/SB115016002768278486.html?mod=health_home_inside_today_left_column

Can a Sugar-Cane Extract Cut Cholesterol?

By LAURA JOHANNES
June 13, 2006; Page D3

"new evidence suggests it may not work after all, and physicians say patients should stick to proven remedies."
...
"almost all the published work comes from Cuba, a sugar-cane producer that has been seeking to create a policosanol industry."
...
"However, two recent studies raise doubts about the efficacy of policosanol."
...
"cholesterol experts say that, unless further independent research shows policosanol works, it's probably a waste of money."

Here's an Idea: Let Everyone Have Options

In the article: "Here's an Idea: Let Everyone Have Ideas"
http://www.nytimes.com/2006/03/26/business/yourmoney/26mgmt.html?_r=1&oref=slogin
it discusses a novel method that Rite-Solutions came up with for finding,
encouraging and developing new ideas and products within their company.
They basically created an internal stock market where each proposal becomes
a stock that can be bought or sold. The value of a "stock" beomes a proxy for
the worth of the idea or product.

Sometimes that works great, but there is also great risk in the idea.
If the stock market always worked (i.e. was "efficient"), we'd all be rich.
But as anyone who lived through the internet bubble can attest, the
stock market doesn't always get it right, and there is no guarantee that
the same effect won't happen with an internal market for ideas.

http://www.fool.com/news/commentary/2006/commentary06030211.htm
The stock market crash following the Internet bubble destroyed portfolios and dreams. The Nasdaq alone fell from 5,000 to below 1,200 -- a nearly 80% decline. And that's only the average. Many stocks became essentially worthless. The tragedy wasn't in the numbers, though -- it was in the effect those losses had on people. Many investors were completely wiped out, losing money they'd been saving for years.

Missing in Action

Well actually, Fundamentally...
If monitoring can prevent the condition from becoming fatal, then proper monitoring should have been in place. and where was the FDA when the trial was approved??
The fact is there are no "good" treatments available for ITP, and all the available treatments have potentially significant harmful side effects themselves.
It seems unlikely that monitoring alone could prevent the problems seen in the trial since the side effects from this drug were already well known - unless the trial design (or follow-through) was bad to begin with.

http://www.thestreet.com/_yahoo/stocks/robertsteyer/10243104_2.html
Among the Campath patients, three suffered from a disease, nicknamed ITP, that can cause abnormal bleeding due to low blood-platelet counts. Two of these patients received high doses of Campath, and one received a low dose. One patient died. "Investors could have flashbacks to the fatal Tysabri side effect," says Thomas Shrader of Harris Nesbitt, in a note to clients. "But we see the situation with Campath as fundamentally different in that ITP is not a fatal condition if proper monitoring is in place. Importantly, Genzyme believes that the ITP side effect can be properly managed by physicians."

http://biz.yahoo.com/bizj/050916/1165703.html?.v=1
"Campath, approved in 2001 for leukemia, already carries the FDA's toughest warning related to the risk of serious and sometimes fatal side effects. That includes a form of the condition found in the multiple sclerosis study."

http://www.campath.com/safety.html
Important Safety Information
"Hematologic Toxicity: Serious and, in rare instances fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia have occurred in patients receiving Campath therapy. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week should not be administered because these doses are associated with a higher incidence of pancytopenia."

Kill Bill

WE hold these Truths to be self-evident,
that all Men are created equal

In a commentary article on MSNBC yesterday
by Arthur Caplan, the director of the Center for Bioethics at
the University of Pennsylvania:
"Advances in prenatal genetic testing pose tough questions"

There is a discussion of genetic testing and autism, with the
emphasis on what might happen if a genetic test for milder
forms of Autism were developed soon, and speculates on what might
happen if geniuses who are suspected of having Asperger’s syndrome
(a milder form of Autism) were prevented from ever being born
in the first place.

While it's commendable that the article actually brings up the
issue of genetic testing and abortion, it's inexcusable for
a "bioethicist" to leave the impression that there's any valid
choice in such situations other than to allow a child to be born.

The article questions whether or not there may be a greater reason
not to prevent a child from being born if there's a chance they might
become a genius.

This is the sad state of ethics today. Even the remotest implication
that someone is more worthy of being born because they might grow up
to become a genius is pathetic, or conversely, that someone is less
worthy because they're not a genius - or more to the point, simply
because they're not perfect.

One might wonder how an article like this could avoid using the
term "abortion". Perhaps it's to avoid the truth. The truth
is that abortion based on genetic testing is nothing less than a form of
Eugenics, and there is a very slippery slope from allowing the personal
"choice" of abortion to state-sponsored Eugenics.

Before you think that's an extremely ominous admonition, remember that
the nation that had the largest eugenics movement after Nazi
Germany was the United States. Genetic testing has made it
all too easy for people today to rationalize abortion.
See another article by Arthur Caplan
"Predictions for a new millennium
Breaking Bioethics offers a look into the crystal ball"
for his own wary prediction regarding Eugenics.

Yet another ominous example of the trend today can be found in a
recent article:
"Abortion is Primary Direction for Obstetricians After Down's Diagnosis Study Finds".

Great Expectations

In an article today on Forbes.com by Matthew Herper:
Study Questions Crestor Safety
He writes:

"Researchers at Tufts University, writing in the journal Circulation, found that doctors were significantly more likely to report serious muscle, kidney and liver side effects during Crestor's first year on the market than they were for other cholesterol-lowering drugs, such as Lipitor, Zocor and Pravachol".

What could possibly have led to such reports?

First of all, and most importantly, all of the other Statins (Zocor, Lipitor, etc.) were introduced before Baycol was withdrawn from the market, so obviously doctors are going to have more expectations of seeing side effects now than they did before Baycol was withdrawn and it is reasonable to believe were more diligent in both looking for and reporting them.

Secondly, As it states at the end of the article:

"There was already controversy about Crestor's safety when it was launched, and doctors may have been more likely to report side effects for it than for the other drugs."

The original journal article can be found here

The authors themselves state that the extent to which negative publicity contributed to their findings is uncertain.

Apparently they also did a concurrent time period analysis, but since you would expect more side effects to show up during the initial introduction of a drug, that analysis is as flawed as their first year of marketing analysis.

In other words, nothing new here...

In the dark

In the news today, "Scientists Say Sunshine May Prevent Cancer".

Contrary to long-standing and well-founded warnings to minimize exposure to the sun to prevent skin cancer, Dr. Edward Giovannucci, a Harvard University professor of medicine and nutrition is apparently espousing the idea that additional sunlight is good for you based on some very tenuous epidemiological associations and very preliminary laboratory studies.

While there are tantalizing hints that Vitamin D may play a role in cancer prevention, it is far from proven that either supplementation or additional sun exposure can prevent cancer. On the other hand, the association between sunlight (UV) exposure and cancer is well established.

This story has gotten wide distribution in the general media, and it may be extremely dangerous - news outlets are already reporting that using sunscreen make cause more cancers than it prevents.

What are some of the extremely tenuous reasons listed in the article for believing that more sunlight/vitamin-D might be beneficial?

1. Cancer is more common in the elderly, and the skin makes less vitamin D as people age.
   
   
2. Blacks have higher rates of cancer than whites and more pigment in their skin, which prevents them from making much vitamin D.
   
   
3. Vitamin D gets trapped in fat, so obese people have lower blood levels of D. They also have higher rates of cancer.
   
   
4. Diabetics, too, are prone to cancer, and their damaged kidneys have trouble converting vitamin D into a form the body can use.
   
   
5. People in the northeastern United States and northerly regions of the globe like Scandinavia have higher cancer rates than those who get more sunshine year-round.
   

They're so ridiculous that it's worth going over them one-by-one:

1. Well, yes, Cancer of all causes is more common in the elderly as genetic damage accumulates and the immune system runs down, so even if their skin does make less vitamin D, that's no reason to believe there's any association there.
   
   
2. Blacks may have higher rates of cancer than whites, but that could be entirely due to genetic or epidemiological factors, there's no evidence that it's due to a difference in vitamin D.
   
   
3. There is an alternaive prevailing view of the link between obesity and cancer, obesity and inactivity can cause the body to release high levels of insulin and other hormonal growth factors, cells exposed to high levels of these substances over an extended period of time may begin to reproduce so quickly that cancer becomes more likely. That may be much more important that any effects of vitamin D.
   
   
4. There is evidence that diabetics may be prone to cancer, but that hasn't been proven. Diabetes is often linked to obesity, and obesity itself is known to increase the risk of cancer.
   
   
5. Stating that people in the northeastern US and northerly regions of the globe have higher cancer rates is a gross exaggeration of the facts:
   http://dceg.cancer.gov/cgi-bin/atlas/mapview2?direct=accswm70
   http://dceg.cancer.gov/cgi-bin/atlas/mapview2?direct=acccwm70
   http://dceg.cancer.gov/cgi-bin/atlas/mapview2?direct=accswf70
   http://dceg.cancer.gov/cgi-bin/atlas/mapview2?direct=acccwf70
   

There's a bug in my study !

In an article yesterday at Medpage Today:

"Aspirin Risks Outweigh Benefit in Elderly"
(http://www.medpagetoday.com/tbindex.cfm?tbid=1071&topicid=38)
The results of a computer model that was used to predict the risks/reward of using low-dose aspirin in people 70-74 years old were presented.

Fortunately, this "news" item doesn't seem to have gotten wide distribution, but it's pseudo-science like this that adds to the confusion among the general public about what health claims to believe.

There's no way to determine exactly how people will respond to a given treatment without a good randomized double-blind clinical trial.

While you might come up with some interesting hypothesis via a computer model, it's no substitute for an in-vivo clinical trial in humans.

They should not have used a title that implied that there was any certainty to their results.

Sugar Pills !

Or in other words: Policosanol.

Policosanol is an extract from sugar cane, which has been suggested to be a natural cholesterol lowering agent.

Now one of the biggest pharmaceutical companies in the world (Bayer Corporation) has come out with a new vitamin (ONE-A-DAY Cholesterol Plus)
http://www.one-a-day.com/products/cholesterol.shtml
that is touted as being able to "help maintain healthy cholesterol levels" due to the inclusion of Policosanol.

What's the problem with that? Well, apparently all of the clinical studies of Policosanol have been done by just a handful of researchers in Cuba.

You can view the actual abstracts here: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=PubMed&term=policosanol

Interestingly enough - sugar is still one of the biggest industries in Cuba, and Policosanol is an extract from sugar cane....

While those studies might have been well done, surely there should be more confirmatory studies done by other independent researchers before touting Policosanol to the general public.

While it might be a non-toxic natural substance with few or no side-effects, if people don't see a doctor because they think policosanol will cure or prevent their problems, or even worse, if they stop taking their prescription cholesterol medications, then people can in fact suffer potentially serious effects.

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ONE-A-DAY and ONE-A-DAY Cholesterol Plus are registered trademarks of Bayer Corporation.