Category: FDA

Bugs R Us: STD edition

~ Pharmer ~ 1 Comment

Bummer.  Another Drug Shortage.  This time Bicillin L-A, the top drug used to inject sufferers of syphilis who come into the ER, is in shortage.   It’s  particularly important for pregnant ladies infected with the little corkscrew Treponema pallidum, as babies being born with the bug is the absolute WORST. Yes, it seems amazing that benzathine penicillin still works on syphilis after all of these years, and wouldn’t it figure that somehow Pfizer can’t make enough to meet demand.  A ‘manufacturing delay’ is cited.

How about that Zika virus??  Now it is claimed that it can be a sexually transmitted disease, passed by just about any kind of sex.

Listen up.  HIV isn’t impressive enough to chill people down just a little bit with with their risk taking behavior. Do you think they’ll care about Zika virus?  Naaaaah.  No one is going to give up SEX for that, however there is one bicyclist Teejay Van Garderen, who has decided to stay home from the summer Olympics in  Brazil this summer because his wife is pregnant, and he doesn’t want to risk transmission.

 

 

Non-news: Obama Administration Complies with Judge Lifting Restriction on Plan B Sales

~ Pharmer ~ 2 Comments

The Obama administration will, as expected, comply with Judge Edward Korman’s order to allow all underage girls, and their rapists to purchase Plan B without restrictions.

The latest news incorrectly states that “If a girl or woman already is pregnant, the pill, which prevents ovulation or fertilization of an egg, has no effect.”

This misrepresentation conflicts with the manufacturer’s own provider information shown below, which recognizes that the pill has multiple mechanisms of action, some of which act AFTER fertilization.  You are not being well served, in matters of science and medicine, by the news media.
Another misrepresentation  involves word play with the term “pregnancy”.  This is now said to begin about a week after embryonic development starts, in order to disguise the fact that Plan B can operate to kill an early human embryo by affecting its ability to implant in the uterus.
Plan B One-Step Mechanism
Note:  Over the counter Plan B, which demonstrates <60 percent effectiveness in actual use, is like condoms with holes in them.

Why are autologous Adult stem cell treatments being Outsourced?

~ Pharmer

Patients from the U.S. have to go to other countries for autologous stem cell treatments  (using the patient’s own cells) because of FDA regulations.

No, it’s not because of any restrictions by President Bush, (which limited funding for  embryonic stem cells, not adult stem cells).

The FDA considers the use of the patients’ own cells as a new drug, because they go through processing for the purpose of increasing their numbers.   Use of such cells would require a new drug application to the FDA, therefore the procedures have to be done in other countries.

A court has recently ruled,  against the interest of Regenerative Sciences, a clinic that treats orthopedic patients, that the FDA retains the authority to regulate stem cell treatments.

Yes, it is the FDA, not President Bush, which is causing  the outsourcing of autologous stem cell treatments.

Read more by Rebecca Taylor @ Lifenews:

Why Don’t Patients Stay in the U.S. for Stem Cell Treatments? | LifeNews.com.

Whoopsie Baby! Sandoz recalls Generic BC pills: Introvale

~ Pharmer ~ 1 Comment

Sandoz  has voluntarily recalled Introvale  brand of birth control pills,  because the placebo pills are in the wrong position of the pack.

If you have lot number : LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C  or  LF01261C,  distributed only in the US between January 2011 and May 2012,  your pills could be less effective than usual for whatever reason you were taking them.

Click the top for the FDA warning.

Raw Milk Suggested As Reason for Low Incidence of Allergies in Amish Children

~ Pharmer

Amish farm kids remarkably immune to allergies: study – Yahoo! News Canada.

The FDA, which shut down Farmer Dan Allgyer’s raw milk business, for health reasons, apparently hasn’t seen  the study which finds a remarkably low rate of allergies among Amish children.   These kids were  compared to  cohorts of other farm children and those who are not raised on farms.  U.S. Amish kids were compared to Swiss kids  in an attempt to control for common genetic factors, and still a considerable difference was seen.

Other studies point to the farm environment, exposure to certain microorganisms, and to cows.   Raw cows milk is also associated with the reduced allergy incidence.

This latest study, led by Dr. Mark Holbreich  showed 7 percent of Amish kids testing positive for a skin prick allergy test,  while  25 percent of Swiss farm kids, and 44 percent of other Swiss children tested positive.

Allergies are big medical business.  Perhaps crony capitalism is the reason that the FDA felt such a need to shut down Dan Allgyer’s farm. 

Drug Shortages Are Speeding Cancer Deaths, Survey Says

~ Pharmer ~ 1 Comment

Drug Shortages Are Speeding Cancer Deaths, Survey Says.

The above claim comes from the results of an Epocrates survey of prescribers. The participants are paid a bit for their time, but the input is stirred up to make the submissions anonymous. What they found is that slightly less than half of the oncologists think that the drug shortages of chemotherapeutic agents have caused recurrences of tumors in their patients. This is due to the inability to properly schedule their treatment regimens due to short supplies. About 40 percent of the respondents think that some patients have died sooner as a result.

This article attributes most of the problem to economics: inadequate reimbursement for generic injectables, which discourages production. Pharmer recognizes the contribution of tax rates and government regulatory burdens from employment, to work place, environment, and production to the problem. The documentation of compliance imposes a dizzying cost, preventing new starts into production of pharmaceuticals.

There’s a Drug Shortage Prevention Act being pushed through to address this problem. It appears to address the manner of FDA oversight of drugs on the market to prevent that agency from causing more shortages, but apparently not the reimbursement issue. This might be best, if the cost of drug production is significantly reduced.

Pharmer likes to watch Medscape, because a lot of useful information is distilled there, though by no means without bias. In order to see most of the articles, you have to join. Check it out.

FDA is Too Busy Going After Small Farmers to Effectively Deal With Drug Shortages.

~ Pharmer

FIRST THINGS FIRST!!

That Dangerous Daniel Allgyer guy, Amish, capitalist seller of unpasteurized milk must be STOPPED, and his farm shut down!
That kind of regulatory activity is top priority.

Meanwhile, there are shortages of vital medications like never before. Afflicted health care institutions must promulgate politically correct excuses for these shortages, but we know that the role of government in exacerbating this situation has been predominant.

The U.S. has some of the highest corporate tax rates in the world. Big Pharma has many incentives, from this, to the OSHA and environmental regulations, to push its production to other countries.
Inside the U.S., if a company wishes to change the site for manufacturing a product, a two year approval process awaits. This means that adapting to drug recalls and shortages is painfully slow. There are tight constraints on production quantities and schedules imposed by the FDA.
A gray market has grown around the shortages. If you know how ticket scalping works……. there are analogous drug scalpers. Since reimbursement for drugs is fixed by medicare and medicaid and other health insurers, health care institutions and providers really can’t afford the gray market prices. There is a need to allocate a team of specialists to manage adaptation to the shortages and a website for clinicians to keep current on the day to day changes and substitutions. The administrators at Pharmer’s workplace have resolved to continue to deal with the shortages without resorting to purchases from the gray market.
Who are the biggest losers? The patients!

The long term result will be to reduce the load on medicare and medicaid, and the government needs that cost containment, especially since the designers of Obamacare have admitted that their cost projections were totally wrong.

So the FDA has more incentive to attend to those dastardly small farmers, than they have to deal with the GINORMOUS drug shortage problem.

Pfizer: Whoopsie Baby!

~ Pharmer

Pfizer Recalls Birth-Control Pills – WSJ.com.

Pfizer recalls Birth Control Pills: Lo/Ovral-28 and the generic Norgestrel and Ethinyl Estradiol tablets due to a packaging error. Over a million dose-packs are recalled, but the company states a belief that only 30 packs are affected. One user alerted the company on Oct 19, that her blister pack had a pink (inactive) pill where a white (active pill should have been. The recall was announced at the end of January.

The recall has the ambulance chasers drooling and people wondering how to blame their pregnancies on the drug manufacturer, regardless of the real reason for failure.

The FDA lists the lots numbers and products involved in the recall.

Is Judge Ed a Ped?

~ Pharmer

Judge to Determine if Pre-teens Can Buy Morning After Pill | LifeNews.com.

Unfortunately we have been allowing too many medically ignorant people to make  legal decisions regarding health. (We’ve also seen some of their writing invade the medical journals.)  Pharmer sometimes  speaks  with  politicians about drug issues. Even the ones who are making a sincere  effort to understand  get the glazed-eyes look when pelted with too much medicinal chemistry and pharmacology.  Others are simply disinterested in  drug mechanisms of action and their  relative risks and benefits.  A third group overlaps,  which has an agenda of increasing sexual access to younger girls, and increasing abortion business by this means.  They  have  political supporters to pay off.

A New York Federal Judge, Edward Korman has agreed to hear a case from from the Center for Reproductive “Rights” on whether the morning after pill should be placed out on store shelves.  This case was filed before the Sebelius decision regarding Plan B.

Judge Edward Korman had previously ordered the FDA to let seventeen year olds obtain the medication without a prescription, so Pharmer already feels that he likes them pretty young, at or just after the legal age of consent.

The next question is whether or not Judge Ed likes them VERY young, before they have the ability to form the first dimple of cellulite in the adipose padding of the female curvatures. Is Judge Ed a Ped?

Pro-life people have to pay a social price for not wanting to participate in killing humans.  We are ostracized,  less employable,  and pelted with every sort of obscene epithet and accusation.  Some do jail time for peaceful protesting, while the much more violent leftie protesters are left to trash public and private property as they please.    There is one law for pro-lifers and another for the lefties.

The usual response from our side  is to try to be sooooo nice and hope that the lefties learn to love us.   Someone needs to tell the USCCB , the Republican party, and various other pro-life groups that this will never happen. (Soon they might  be where the Egyptian Coptic Christians  are now.)

Pharmer is not in the mood to be nice to sexual  predators, and those who profit from them.

Maybe Judge Ed will wake up and determine that it is just too sick to let guys buy or steal these pills so easily  and use them on drugged out pre-teen runaways who have been pressed into prostitution.

But if he doesn’t…. it would mean that there’s  something hugely wrong with him and his family, that they’re abnormal.   Should your kids be allowed anywhere near such people?  Would you want to be known to socially prefer the company of sex perverts?  Would  you then  feel safe in Judge Korman’s  neighborhood or want him at your school functions?

These are the things which need to be decided. What kind of world to you want to live in?  What will you do to adjust your environment so that it doesn’t deteriorate any further?   People who are interested in the well being of their children should be protecting them from the ones who think that it’s OK for an 11 year old to be having sex and buying plan B with their school lunch money, or being fed with the pills by sexual predators.

Mental Meanderings– The 180 Degree Turn on Plan B

~ Pharmer

Yesterday was interesting. There was a call from “Maggie” who wanted to know if the Pharmer would speak with ABC News reporters (for Diane Sawyer’s program) concerning the FDA’s idea to allow Plan B to be sold on store shelves. This was said to be a followup to a story from LONG ago featuring yours truly.

The ever agreeable Pharmer said “yes”, and mentioned that the FDA should be concentrating on the rampant shortage of essential medications, rather than messing around with Plan B. “Maggie” said there would be a call back to time the interview. ………. That, of course, was not to be, because VOILA!! The story changed radically and they likely no longer wanted to parade the weird pro-life pharmacist , who does not wish to kill humans at any stage of development.

So. to those who think the lefties are not happy with the results, and their party was squashed, and they need a Waaaaambulance…….. You are CORRECT, and that includes the mainstream media.

The lefties are wailing and gnashing their teeth about pre-teens and men not being able to purchase or steal Plan B from the shelves. It’s been fun to read their comments on some of the news sites.

Pharmer originally thought Sebelius possibly felt she had collected enough barnacles and “bad Karma” in Kansas, with respect to facilitating the abuse of minors, abusing Phill Kline, and “losing” documents. She perhaps no longer wanted that to be highlighted and discussed everywhere she looks. So perhaps she decided to give her agenda a rest for once.

Another alternative idea is that Sebelius is actually recalcitrant, and wanted to allow the FDA decision to fly. Perhaps she was ordered from above to countermand the FDA recommendation, and WAIT TILL AFTER THE ELECTION to allow it.

From a practical standpoint, the items which are often stolen wind up being locked up in stores. Plan B One-Step would be one of these, because a person can easily break into the box, take the pill and leave the empty container with it’s little alarm device still inside. So perhaps it would not be placed out with the condoms after all.