Category: health care

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.

 

Maine gets break in federal health care overhaul – CNBC

~ Pharmer

Maine gets break in federal health care overhaul – CNBC.

Another Obamacare waiver for the whole state of Maine!   This will be a three year reprieve from the requirement that insurers spend “80 to 85 cents of every premium dollar on medical care and quality improvement”.  It includes a review in two years.

This was provided in the face of the threat that MEGA Life and Health Insurance, which provides 37 percent of the states  insurance for individuals would withdraw entirely from the market.

The plan for Obamacare had been that insurance companies could survive until the the government had organized sufficiently to take on the single payer system.    This is obviously not working.

Baby Joseph Update, Ontario Canada

~ Pharmer

Although the medical records should be released to Joseph’s Maraachli’s parents upon request, according to law, London Health Sciences Centre in London, Ontario, is witholding them. This appears to be an effort to prevent the transport of Baby Joseph to a U.S. hospital where a tracheotomy can be performed.

Health care professionals are standing by and donated medical equipment is available to manage the difficult condition of Baby Joseph which appears to be far beyond the capabilities and fiscal reach of Ontario, Canada. (This is the kind of health care system intended for the U.S., under Obamacare).

According to advocates, the only thing standing in the way of providing for home care for Baby Joseph is this withholding of medical records. One wonders if legal experts at the hospital are combing the medical records for any improprieties before passing them on in this very public case.

Canadians Shopping in U.S. for Bargain Medical Prices

~ Pharmer ~ 1 Comment

Canadians buy U.S. health care as weak economy pushes down prices – The Globe and Mail.

Wait times and availability of  health care has long been sending  Canadians southward to the U.S. for care.   This migration is increasing due to economic downturns and new bargain rates for medical procedures.  U.S.  health facilities are actually negotiating  with Canadian health care brokers and matching prices.

This state of affairs has sent people of more moderate means into the U.S. health care market for such things as joint replacements and cardiac procedures.

Let’s hope that a private system can remain in place for those who think their health is worth the money.

Weekend Business: Repeal of Bush’s Conscience Protections for Health Care Professionals

~ Pharmer ~ 3 Comments

It’s a whisper in the news……. You’d have to dig hard to find it.  Obama gutted the  regulations Bush had put into place to protect conscientiously objecting health care professionals from discrimination.

There were essentially no new provisions in Bush’s executive order, except to cause institutions to worry about receiving federal funds if they discriminated against health care professionals who refuse to kill humans in their practice.

Obama has returned the situation to its previous state:  toothless conscience legislation, nearly unenforceable because  unemployed health care professionals usually lack  funds to bring civil redress when incidents of discrimination occur. Also,  what remains of “protection” will only apply to what is obviously recognized as abortion to a layman,   and sterilization.   Objection to chemical abortions at the early stages of human development, and use of various biotech medical devices, unethically derived drugs, vaccines, transplants, implants  (from killed humans) will not be covered.

Actually the situation is worse than it was previously, as the department of Health and Human Services has utterly no interest in hearing or cataloging incidents of discrimination.   The head of this department, Kathleen Sebelius   had no interest in enforcing medical standards applicable to abortion clinics in her home state of Kansas.

It is fortunate  that the new Congress has shown some interest in this situation, otherwise it might be missed entirely by the public.

The actual  repeal is gibberish,  unless one has intimate  familiarity with the underlying laws and regulations.  Heritage Foundation has pretty much put it in English.

The Sebelius HHS will effectively leave conscientiously objecting health care professionals without protections,  and  all should be prepared to find new jobs or careers should a conflict between the employers mandates and personal conscience ever arise.

As  previously, the protection of conscience for health care professionals will largely lie in the power of the internet, to expose  institutions  which  discriminate against health care professionals who refuse to kill, and reduce private business, and  the sources of charitable   donations, funds and grants.

Democrat Senators Promise to Protect Obamacare Abortion Mandates

~ Pharmer ~ 1 Comment

Dem senators promise to block House abortion legislation – The Hill’s Healthwatch.

Because Obamacare really does cover abortion, and the democrats want to keep it this way.    If this were not the case, there would be no need to force health care institutions, insurance companies, and health care providers to participate in abortion.

Stopping this bill would be a moot point if the above were not the case.

We all know better, don’t we.   Thanks for reminding the American People how much you need to be replaced, DEMOCRAT senators.

2012 is coming fast.

Obama Attack on Abortion Conscience Clause Likely Imminent | LifeNews.com

~ Pharmer ~ 1 Comment

Obama Attack on Abortion Conscience Clause Likely Imminent | LifeNews.com.

One of the first things Obama did when he took office was to begin work on removing department of Health and Human Services ability to enforce existing conscience protections for health care professionals who refuse to kill humans in their practice.

Some of this  work will likely be completed at the end of this month with recission of Bush’s executive order allowing for removal of federal funding to the institutions which descriminate against physicians who refuse to participate in abortion.

Obama expects health care practitioners to kill humans, and this is a main reason why  both the New England Journal of Medicine and the Investors Business Daily surveys revealed that almost half of physicians intend to retire early in the event of Obamacare.

Your health care might be free, but you won’t be able to get any in a timely manner, and you might not like what remains in the professions after the ones who refuse to kill their patients leave practice.

The American College of Obstetricians and Gynecologists consider participation and referrals for abortion to be a necessary part of practice to retain their Board certification.   In other words, it may  soon be a drawback to have your baby delivered by a board certified obstetrician.

Virginia to seek expedited Supreme Court review of suit over health-care law

~ Pharmer

Virginia to seek expedited Supreme Court review of suit over health-care law.

Ken Cuccinelli, Atty. General of Virginia is petitioning the U.S. Supreme court for expedited review of the Obamacare case.  Of course the Obama administration’s “justice” department is opposing this as they would like to destructure the insurance companies and dismantle enough of the present system as possible before an actual repeal or reversal could occur.   This would make people miserable and impatient during the next, more conservative administration and hopefully place Dems back in power after people forget their socialistic hubris.

Such expedited reviews by the Supreme Court are a rarity, but would be very nice in this case, to prevent destruction of the current system, and  dissolution of the health insurance industry, as well as extreme waste of taxpayer dollars.