Tag: FDA

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.

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.

Indiana Senate Bill 72

~ Pharmer ~ 2 Comments

Since the time Pharmer was first informed of current Indiana legislation to regulate the use of abortion drugs,  there have been significant changes to the bill.

Of special concern is that no longer a  requirement to report adverse events associated with abortion drug use.
Existing  forms and services can be used  for such reporting with respect to drugs and medical devices,  for example:
http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf

Adverse events associated with or related to childbirth are reportable as such to  include the whole period of pregnancy, childbirth and the year after delivery, at the recommendation of the ACOG.
The non reporting of abortion related adverse events and deaths, combined with the more readily reported pregnancy related or associated deaths has led to false statistics comparing the relative risk of childbirth and abortion.
Senate Bill 72 is now structured in such a way as to facilitate a means to convince women  that abortion is safer than childbirth.   The lack of requirement for reporting abortion drug adverse events  serves to worsen the current  skewing and misrepresentation of facts, which denies patients the opportunity of giving informed consent.

Useful parts of the bill worth noting:  The definition of abortion inducing drug includes “off-label use of drugs known to have abortion inducing properties if the drug is prescribed with the intent of causing an abortion”.  (Ch.3 sec.1a)
The bill also requires that the abortionist  “follows the drug label protocol for the abortion producing drug. (Ch3. sec 3a-2)
Expect a firestorm from planned parenthood which utilizes mifepristone, RU-486, in an off label manner by using less of the drug  (a single 200mg tab) than recommended on the label, (three 200mg tablets)  and by using it up to, or at 63 days gestation instead of 49 days.
According to the Mifeprex label, U.S.,  three x 200mg tabs are to be administered in a single dose, and the patient returns to the clinic in 2 days to take 2 tabs (400mcg) of misoprostil, to expel the human embryo or fetus.   Planned Parenthood of Indiana is sending the patients home with four tablets (800mcg) according to their own info.

From Drs Gary and Harrison at Medscape:  “The US clinical trial demonstrated a failure rate of 8% at 49 days or less from the last menstrual period (LMP), increasing to 17% at 50-56 days from the LMP, and further increasing to a 23% failure at 57-63 days from the LMP, as established by sonographic criteria………One serious concern raised by this review of AERs is the suggested fetal malformation rate of at least 23% following mifepristone failures that resulted in continuation of a live pregnancy.”

Annals of Pharmacotherapy analysis of mifepristone adverse events reported to FDA 2000-2004.

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.

Comparing Listeria Hysteria and Response to Deaths Associated with Abortion Drugs

~ Pharmer ~ 1 Comment

Obama’s CDC Stops Bad Fruit, Ignores Abortion Drug Deaths | LifeNews.com.

The CDC has recommended that people avoid  cantaloupe from Jensen Farms, Colorado, which is suspected to carry  Listeria, a bacterial cause of potentially fatal food poisoning.  Cheryl Sullenger points out another governmental double standard, (much more egregious than the selective enforcement of the migratory bird protection laws highlighted HERE).

13 deaths and 72 illnesses have been attributed to eating cantaloupe from the Colorado farms.   Laura Anderko, a food safety specialist from Georgetown U.  suggests that people should throw away their cantaloupe if they’re not sure where it’s from.

There’s no such governmental reaction   to the deaths and adverse effects suffered by users of  mifepristone and misoprostil.  The abortion regimen is still being promoted as safe, after reports of 14 deaths and 2207 adverse effects associated with use of  the drugs.

 

Why Do Peyton Manning, Americans Leave U.S. for Stem Cell Treatment? | LifeNews.com

~ Pharmer

Why Do Peyton Manning, Americans Leave U.S. for Stem Cell Treatment? | LifeNews.com.

Rebecca Taylor,  author of the Mary Meets Dolly blog, comments on the reasons for medical tourism out of the United States for AUTOLOGOUS stem cell transplants.  These use the patients own cells, so there are no ethical restrictions in law regarding these procedures.  The road block for this kind of treatment is the FDA, which regards the treatment as a DRUG, and regulates it as such.

Click the top to read more.


FDA Attempts to Patch K-V Pharmaceuticals Progesterone Mess

~ Pharmer

FDA Allows Cheaper Version of Preterm Labor Drug To Stay on the Market – Health Blog – WSJ.

A short time ago, there was an uproar because the FDA had given approval to KV pharmaceuticals to be the sole producer of 17-alpha-hydroxyprogesterone caproate, (Formerly named Gestiva)  a drug used to sustain pregnancies in women who produced insufficient amounts of progesterone.

Pharmacies had been preparing these doses and supplying them at about 10 or 20 bucks apiece.

KV had sent a letter to the pharmacies announcing that compounding the doses would no longer be allowed, and that their drug, Makena, at $1500 dollars per dose would be the only drug available. It is extremely important to know that  K-V has no research and development costs to recoup with the introduction of their commercial form of a drug which had been studied and used for years. In fact, fast approval of Makena was based upon a 2003 study funded by the NIH.

This drug is injected weekly to sustain a pregnancy, so you can imagine the cost to the affected mothers. Suddenly the cost of preventing premature babies in the US would be jacked up to multiple billions of dollars.

Of course Obamacare would have the death panels to halt that source of excessive cost.  K-V would need to recoup its investment very quickly.

The new drug by KV pharmaceuticals was named Makena.  The sound of this name set off bells in the mind of yours truly, wondering who paid off Obama to get this windfall of profit due to exclusivity granted by the government for K-V Pharmaceutical Co.   You betcha…. Makena is a Hawaiian boy’s name (but can be given to girls).  The meaning is ABUNDANCE, as in windfall profits for K-V. There HAS to be a political connection larger than the individual political contributions from K-V employees. ……. and it will be unearthed.  Watch closely because some articles are already being scrubbed from the internet.  Two dead ends so far.

Fortunately, this obvious and unconscionable scam and, granting of monopoly status, (similar to the quinine sulfate scam) met with immediate protest.

The FDA now says that the letter from K-V pharmaceuticals was in error, and that pharmacies will not be forbidden to compound doses of 17-alpha-hydroxyprogesterone for individual patients.

More delectable goodies follow:

Adeza is the company which first submitted Gestiva to the FDA for approval in 2006, based on a study paid for by the NIH.  It obtained orphan drug status in Jan, 2007

Adeza merged with Cyctec, and Cyctec merged with Hologic.  And here’s a whole Makena timeline! The blogger estimates that K-V would recoup its entire investment in purchasing the rights of the drug in two short months, at the initially planned, astronomical price.

Hologic  Inc. sold the total rights to its product, Gestiva, 17-alpha-hydroxyprogesterone caproate to K-V Pharmaceuticals in 2008.

K-V Pharmaceuticals was perhaps needing a boost from the government (granting it a monopoly)  because it’s subsidiary, Ethex had been required to recall  incorrectly made pain killers containing excess amounts of active ingredient. More K-V disasters resulted from selling unapproved drugs,  and from dismissal of a vp of corporate strategy and operations.  This company was on the verge of bankruptcy.

K-V’s windfall profits  could be   targeted by lawsuits concerning still births attributed to 17-hydroxy-progesterone, as well as increased incidence of pre-eclampsia and gestational diabetes.

March of Dimes bears responsibility for helping to initiate this debacle, and has been burned by the result.  Here’s the result of their  collusion with MOD DONOR K-V Pharmaceuticals.

 

House May Block Food Safety Bill Over Senate Error : Roll Call

~ Pharmer

via House May Block Food Safety Bill Over Senate Error : Roll Call.

Senate Bill 510, the Food Safety bill which gives the  FDA more authority over food regulation, and putting  small food producers out of business,   is hung up due to a violation of congressional authority.   The Senate bill has tax in it.  Taxes are supposed to be initiated in the House.  Whupsie,  Harry Reid screwed up  again.

The house will throw it back to the Senate, and they’ll have to rework it.  This would normally require the cooperation of the republicans.

Maybe the bill will DIE this year.  One can only hope.

YouTube – SO IT STARTS – Senate Bill 510 – Organic Farmer Fined 5000 For Growing Crops On Own Land

FDA Approves Ulipristal acetate as Expected

~ Pharmer

Watson is the generic drug manufacturer which is expected to distribute EllaOne in the US, now that the FDA has approved it for use as a morning after pill.

Headlining at Pharmacists for Life International is a low opinion of the FDA’s decision to spend time on this me-too analog of the abortive drug, mifepristone (RU486), and allow the marketing as a morning after pill.
Below is what Pharmer sent to Rob Stein of the Washington post, at his request. It’s possibly not translatable into language understandable by that newspaper’s readers.

On the sidebar and searchable on this blog is further information on Ulipristal acetate, coming soon to the US, for use in underage girls, (without parental consent) and by women who are ill-informed about the drug and its effects.

Reply to request for statement on the impending approval of Ulipristal:

Ulipristal Acetate, according to its developers, can kill embryos and fetuses, and is marketed in Europe as EllaOne. The low dose 30mg form, has been prioritized for approval by the FDA, which would have served us better by adequately addressing the current, rolling shortages of lifesaving and essential medications.

The embryocidal, ulipristal acetate doses may be accumulated by physicians or patients for medical abortions at home, sidestepping the so-called regulation of mifepristone/misoprostil (the other abortion drug). This will lead to additional life-endangering problems for the targeted adolescent girls and women.

The FDA is expected to continue in its long tradition of relegating females to bottom class health care status.

Reply when asked if pharmacists would refuse to dispense it:

Pharmacists were excused from handling mifepristone/misoprostil, and most were relieved to be sheltered from the ethical and legal liabilities.
The majority would not like providing information and dispensing ulipristal, since it is an analog of mifepristone. Expect attempts to force pharmacists to do so.

If you were to juxtapose the issue of severe drug shortages and the approval of this ‘me-too’, abortifacient in a survey of pharmacists, the majority would express the opinion that the FDA is nearly useless.

Personal note to Rob Stein concerning the FDA’s action:

In my place of employment is a gigantic board listing the shortages and outages of essential medications, such as antibiotics, pain relievers, anaesthetics and drugs for sedation.This problem has been significant for years, and has worsened considerably in the last year, impeding our ability to provide vital care for our patients.

The FDA has placed the approval of this duplicate analog of mifepristone ahead of need to address this severe health care issue. My disrespect for the FDA is profound and beyond the ability to verbalize.