Wednesday, July 03, 2013
My Gmail inbox is getting a constant stream of emails on all sorts of subjects that offer me a "guest opportunity". Apparently they think I might want to interview a person who knows something about some subject. I have been getting such emails only since the last month or so and I hope they go away soon. In the meanwhile I am marking them all as spam. If they sent me a straight report on some subject I might use it but I have no time to waste on "Guest opportunities"
Behind the Dorian Gray facade
Why are babies dying of inadequate nutrition in AMERICAN hospitals?
Drugs and IV nutrient shortages that one would normally expect only in the Third World are common. Why? The "war" on drug companies by the FDA and others makes much production unprofitable or legally perilous
Emptyhead in 2011 signing a bill that was supposed to fix the problem. The problem got worse
A 2012 report by the House Committee on Oversight and Government Reform places much of the blame on the FDA. The report says that because the agency ramped up inspections and sent a flurry of warning letters, “four of America’s five largest manufacturers of generic injectable products” simultaneously shut down 30 percent of their manufacturing capacity.
FDA officials have responded that the increase of warning letters was only a “modest fluctuation” that didn’t correlate with the dramatic increase in shortages.
But records show that the number of warning letters related to drugs and biologics nearly doubled between 2009 and 2010, from 34 to 60, before falling to 48 the next year. The recent surge in shortages began in 2010.
Manufacturers are reluctant to talk. APP Pharmaceuticals, which produces calcium gluconate, sodium phosphate, and magnesium sulfate, and American Regent, which makes several IV nutrients currently in shortage, both declined to comment for this article.
“There’s no upside to our guys talking about that,” says a spokesperson for a manufacturers’ association. “Even if the FDA’s doing something terrible, we can’t criticize them. They regulate us. There’s not one cause of drug shortages. But if you call the FDA, they’ll say it’s our fault.”
Indeed, in a July 2012 letter to Congressman Elijah Cummings, a ranking member of the Oversight and Government Reform Committee, FDA assistant commissioner Jeanne Ireland passed the buck. “The root causes of drug shortages . . . lie largely outside of FDA’s purview,” she wrote. “During 2011 nearly 70 percent of all drug shortages were related to manufacturing production problems, including quality-related issues and delays. . . . In 2012, quality-related problems and delays have continued to account for the majority of shortages, especially those involving sterile injectable drugs.”
Valerie Jensen, associate director of the drug-shortage staff at the FDA’s Center for Drug Evaluation and Research, says the main cause of the current nutrient shortages has been the shutdown of American Regent. The company had recalls of IV calcium gluconate, dexamethasone sodium phosphate, and potassium phosphate, among other injectables, because of visible particulates (such as glass or silicone) in the products, which could disrupt blood flow. In 2011, the FDA sent the company a warning letter. At the end of 2012, Jensen says, the company chose to shut down to address its problems. Instead of reopening after 30 days as planned, as of press time it was still not fully operational.
Hospira cites “the difficulty of ramping up production to cover for the unanticipated loss of production from that manufacturer” as another factor contributing to the shortages, a company spokesman says in an e-mail. Hospira makes several injectable nutrients—plus lipids and injectable vitamin A—that are in shortage.
American Regent has begun to release small quantities of calcium gluconate and sodium phosphate, but there are still particles inside that pharmacists must filter out. The FDA wouldn’t normally allow these vials into the market.
“It is a risk, but the risk of not having the drugs is greater,” Jensen says. “Because we know the filter renders the drug safe for use, we felt this was the way to get that drug available for patients.”
The House committee report doesn’t mention the reasons the FDA cautioned the manufacturers. At some facilities, the agency found mold on the walls, open containers of urine, and metal chips in vials—serious problems, to be sure. An examination of FDA inspection letters reveals dozens of additional infractions. But the report notes that a review of the violations “did not find any instances where the shutdown was associated with reports of drugs harming customers.”
A March 2013 committee follow-up letter—which was obtained for this article but has not been made public—directs the FDA to turn over documents and appear for a briefing “in order for the Committee to understand how FDA is managing the drug shortage crisis.”
The rationing pits patient against patient, forcing health-care practitioners to decide who gets a critical nutrient and who has to go without.
“It appears that FDA failed to properly balance regulatory benefits and regulatory costs when the agency took actions that effectively shut down a significant amount of manufacturing capacity at most of America’s major producers of generic injectable drugs,” the congressional letter states.
The letter echoes an accusation in the original report that the FDA knew as early as mid-2011 that its enforcement measures might lead to shortages. That’s when FDA warning letters began to mention shortages, instructing manufacturers to contact the agency before making a decision that would result in a drop-off in production.
Jensen says the FDA changed the language after the drug manufacturer Teva closed down in 2010, triggering shortages of cancer drugs. “If FDA sends a warning letter, it just tells the company what they need to correct,” Jensen says. “If they decide they need to shut down, that’s a decision they make, but it’s something we try to avoid.”
The committee letter also accuses the FDA—based on January briefings with industry representatives—of taking too long to provide feedback on manufacturers’ plans to fix problems the FDA asked them to correct.
“FDA has been very slow to react and to do anything,” says Blair Childs, senior vice president for public affairs at Premier Healthcare Alliance, a large group-purchasing organization (GPO). “There’s a ‘we’re not the cause of the problem’ mentality.”
The manufacturers’ spokesperson says the FDA is constrained by “an enormous mandate without enough resources. They don’t have enough trained people; they don’t have enough money. The FDA’s always getting negative feedback for what they do wrong, and nobody’s standing up and saying the FDA could do a better job—here’s some more money.”
Jensen disagrees: “We feel like we are adequately resourced. Our drug-shortage program has greatly expanded. FDA has devoted great resources to this and will continue to do so.”
Many doctors are pinning their immediate hopes on Congress’s forcing the FDA to form a global pipeline to import an emergency supply. “I have friends in other countries who could get me some, but that would be illegal,” one doctor says.
When Miguel Sáenz de Pipaón, a neonatologist at a prominent hospital in Madrid, arrived in the US for a research visit, he was stunned by the nutrition shortages.
Hospital staff wonder why the FDA hasn’t already put a process in place to streamline foreign inspections and certifications so that labs abroad can manufacture emergency supplies on short notice.
An FDA spokesman says officials began looking into importation after American Regent’s 2012 shutdown. But that company’s recalls began in 2010, and it first suspended manufacturing operations for more than a month in 2011.
The FDA must have been aware of problems because regulators sent American Regent a warning letter in September 2011. Moreover, the FDA allowed the company to release vials of potassium phosphate contaminated by particulate along with a filter in 2011. Knowing that American Regent produced more than half a dozen nutrients critical to neonatal health, couldn’t the FDA have searched for importation possibilities back then, secured a backup manufacturer, and avoided the current shortages?
“The FDA has repeatedly told us that the shortages are short-term and that they don’t need to import yet,” says neonatologist Steve Abrams of Texas Children’s Hospital. “There’s been a general sense that this problem will go away if we just wait until next Tuesday, and next Tuesday just hasn’t come for the last 2½ years.
Obama's Final Word: Catholics Must Buy/Provide Coverage for Abortion Drugs
The Department of Health and Human Services today released the final text of the final adjustments to the Obamacare regulation that requires virtually all health-care plans to provide cost-free coverage for sterilizations, contraceptives and abortion-inducing drugs.
Catholics and Evangelical Christians have objected to the regulation, arguing that it violates their First Amendment right to the free exercise of religion. The Catholic Church teaches that sterilization, contraception and abortion are all intrinsically immoral. Evangelical Christians believe that abortion takes an innocent human life and is thus wrong.
The final regulation issued today provides no accommodations at all for individual Catholics and other Christians who morally object to the mandate. It also makes no accommodations for private for-profit employers who morally object to the mandate.
Catholic and other Christian individuals in the United States will now be forced by the Obama administration to buy insurance coverage that pays for sterilizations, contraceptives and abortion-inducing drugs--whether they want that coverage or not and even though it forces them to act against their faith.
What these final adjustments to the regulation do is provide what the administration calls "accommodations" to religious non-profit organizations only--or what the regulation calls "eligible organizations."
To be an "eligible organization" a group must be "a nonprofit entity" that "holds itself out as a religious organization." Organizations that certify that this is the case, however, will not be wholly liberated from providing health-insurance plans that provide access to free sterilizations, contraceptives and abortion-inducing drugs. What they will have is a convoluted relationship with their insurance company or, if they self insure, with their third-party administrator.
According to the regulation, when a religious non-profit insures its employees through an insurance company, the insurance company will be required to provide free sterilizations, contraceptives and abortion-inducing drugs to the religious non-profit's employees free of charge. Theoretically, the particular health insurance plan that the religious non-profit buys from an insurance company will not itself buy these things. Instead, in theory, the insurance company providing the health insurance plan to the religious non-profit will use other money that is theoretically walled off from the premiums it received from the religious non-profit to buy the services that violate the non-profit's religious beliefs.
Figuratively, the insurance company will take the money for the insurance premiums from the religious organization and put them in its right pocket. When the insurance company needs to pay for a sterilization procedure or an abortion-inducing drug for one of the religious organization's workers, it will take the money to pay for that out of its left pocket.
When a religious non-profit self-insures, the third party administrator will either have to pay for the sterilizations, contraceptives or abortion-inducing drugs itself, or arrange for an insurance issuer to do so. In this scenario, the regulation says the government will compensate the third party administrator or insurance company by providing it with an accommodation in the fees it pays to the state insurance exchange.
The regulation does not address the right of insurance companies or third-party administrators not to be forced by the federal government to pay for sterilizations, contraceptives and abortion-inducing drugs. Thus, people whose religious and moral beliefs hold that these things are immoral will be precluded from operating businesses in these industries.
For example: A Catholic university could not contract with an insurance company owned by a Catholic family to provide its insurance--because the Catholic family just like the Catholic university would be prevented by its faith from paying for sterilizations, contraceptives and abortion-inducing drugs. Under the final regulation, the insurance company for a Catholic university will be forced to pay for sterilizations, contraceptives and abortion-inducing drugs.
Catholic non-profits, under the final regulation, will be forced to patronize for-profit businesses that have no problem with killing unborn children.
The only people left in America who would be able to operate health insurance companies and third-party administrators would be those people ready and willing to pay for abortion-inducing drugs.
Individual Americans and privately owned companies, including family-owned companies, are given no accommodation at all in the final regulation. Individuals must buy insurance that covers sterilizations, contraceptives and abortion-inducing drugs. Privately owned for-profit businesses that provide insurance to their workers must covers these things--even if they believe paying for and providing such things is immoral and against the teachings of their faith.
The First Amendment says Congress can make no law "prohibiting the free exercise" of religion.
The Obama administration now says to Catholics and other Christians who oppose sterilization, contraception and/or abortion: You are not free to exercise your faith. You must act against its teachings. You must do what we say, not what your conscience says.
For more blog postings from me, see TONGUE-TIED, EDUCATION WATCH INTERNATIONAL, GREENIE WATCH, POLITICAL CORRECTNESS WATCH, FOOD & HEALTH SKEPTIC, AUSTRALIAN POLITICS, IMMIGRATION WATCH INTERNATIONAL and Paralipomena (Occasionally updated) and Coral reef compendium. (Updated as news items come in). GUN WATCH is now mainly put together by Dean Weingarten.
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Posted by JR at 12:35 AM