Are Obama’s DEATH PANELS already killing people via prescription Drug Shortages ?
By:Â on Tuesday, August 23, 2011 at 7:02pm Â
AreÂ Obama’s DEATH PANEL’s already killing people via prescription Drug Shortages?
FDA to blame for critical prescription drug shortage causing deaths throughout the U.S.
Conspiracy theorists could easily make the argument that the growing prescription drug shortage is one way of achieving population control, weeding out the elderly, the chronically ill or infirmed and the weakest links within society.
It could also be possible that the shortage is something created to be used as another part of the liberal agenda’s Â argument for why the Â Government should be in charge and in control of literally all aspects of America’s healthcare system.
The possibility exists that there could be some truth to such theories, that possibility is not quite as farfetched as you might think when one considers that even though the shortage has only recently reached Crisis stage, the problem has existed and been a growing concern for nearly a decade. Â During that time, the United States Food and Drug administration has been completely aware of the rapidly growing Â existence of the problem, Â and yet until just recently, the FDA did very little, if anything to combat what has now become a (in several cases) fatal situation. In fact, with certain prescription drugs, the FDA has put in place increasingly tighter access restrictions further exacerbating the situation for patients, their physicians, and hospitals.
For the moment Â though, lets hold off going down the conspiracy theory road until we examine the frequency with which it is happening, the severity of the problem, and the reason it has reached crisis stage without most Americans knowing that a problem even existed.
Critical shortages of lifesaving drugs are threatening hospital care in America, delaying patient treatment and limiting the medicines doctors can prescribe and the anesthetics they can use to perform surgery.
In the past few weeks, several pharmaceutical giants have warned doctors not to start patients on some medicines because they can’t guarantee a steady supply, and hospitals have begun rationing some vital drugs. The Food and Drug Administration had reports of 180 drug shortages as of July 31, a number that already surpasses the record 178 shortages reported for all of last year.
The ever-increasing shortages affect young and older Americans alike, anyone undergoing Â surgeries, suffering an infection, or being treated with a prescription medication, including those undergoing life saving cancer treatments, are at risk doctors say.
Recent surveys by hospital and pharmacist groups tell the troubling story. A national survey by the American Hospital Association in June found that 99.5 percent of hospitals have experienced one or more drug shortages in the last six months. Nearly half of the 820 representative hospitals contacted â€” 44 % â€” reported shortages of more than 21 drugs. Moreover, 63 percent of the hospitals reported that in some cases, patients didn’t receive the recommended treatment; 10 percent said that problem occurred frequently.
Because of the shortages, “we’ve had deaths â€¦ we’ve had medication errors,” says Michael Cohen, a pharmacist and president at the nonprofit Institute for Safe Medication Practices in Horsham, Pa. As an example, he referred to the case this year in Alabama whereÂ 19 patients were seriously infected and nine died because a standard, premixed solution for IV feeding tubes wasn’t available, so a pharmacy mixed its own and it was contaminated.
Why the shortages of these critical drugs?Â The FDA says the problems mainly stem from manufacturing issues, such as drug production temporarily shut down because the plant wasn’t sterile.Â Sometimes, though, theÂ shortages are tied to disruptions in the supply of raw materialsÂ or to increased demand for some drugs. And,Â the FDAÂ says,Â some companies have simply stopped making older, less profitable drugs,Â particularly older sterile inject able drugs.
When one company has a problem or discontinues a drug, it’s difficult for other manufacturers to increase production quickly. The FDA recently asked manufacturers to report production problems or changes that might cause potential shortages.
Remedies vary butÂ the FDA can work with other U.S. manufacturers to ramp up their production of a drug in limited supplyÂ or search overseas for suitable companies willing to import the drug. It also can help drug makers locate new supplies of raw material and certify them for import.
The drug supply glitches, which vary from region to region and week to week, have triggered congressional interest because the FDA claims it is limited in what it can do to solve the problem.
February 8, 2011 â€” A new initiative that will help address and prevent the ongoing prescription drug shortage in the United States has been announced.
The ongoing shortages â€” the worst in recent yearsÂ â€” affect around 180 drugs that are deemed “medically necessary,” including many chemotherapy, anesthetic, and analgesic agents. Oncology has been hit hardest, and the shortages are placing cancer patients at risk, as previously reported byÂ Medscape Medical News.
New legislation, introduced by Sens. AmyÂ Klobuchar (D-Minnesota) and Bob Casey (D-Pennsylvania),Â will require prescription drug manufacturers to give early notification to the US Food and Drug Administration (FDA) of any incident that would likely result in a drug shortage.Â These factors mightÂ include changes in raw material supplies and manufacturing capability, or certain business decisions such as mergers and acquisitions that could affect output.
Among the cancer drugs in short supply “In some of these cases, there are no equivalents, there are no work-abounds,” Dr. Link, a pediatric oncologist at the Lucile Packard Children’s Hospital at Stanford University, California, toldÂ Mindscape Medical NewsÂ in a recent interview.
“This is the most difficult problem here â€” <there are> drugs that are well known and well established as critical components of standards of care, and <we> know from past trials that not having that drug will result in inferior outcomes,” Dr. Link pointed out. This could result in shorter survival times, he added.
Also announcing support for the legislation was the American Society of Health System Pharmacists, describing it as a “critical first step toward addressing the serious public health threat posed by drug shortages.”
Government Price Controls Produce Cancer Drug Shortage – Who Would Have Guessed?
Ronald Bailey | August 8, 2011
In the SundayÂ New York Times, bioethicist Ezekiel Emanuel describes how the federal government has created a cancer drug shortage. As he notes:
RIGHT now cancer care is being rationed in the United States…
Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply. They include drugs that are the mainstay of treatment regimens used to cure leukemia, lymphoma and testicular cancer.
Why? Because of what are essentially government prices controls on generic cancer drugs.
If the laws of supply and demand were working properly, a drug shortage would cause a price rise that would induce other manufacturers to fill the gap. But such laws do not really apply to cancer drugs.
The underlying reason for this is that cancer patients do not buy chemotherapy drugs from their local pharmacies the way they buy asthma inhalers or insulin. Instead, it is their oncologists who buy the drugs, administer them and then bill Medicare and insurance companies for the costs.
Historically, this â€œbuy and billâ€ system was quite lucrative; drug companies charged Medicare and insurance companies inflated, essentially made-up â€œaverage wholesale prices.â€ The Medicare Prescription Drug, Improvement and Modernization Act of 2003, signed by President George W. Bush, put an end to this arrangement. It required Medicare to pay the physicians who prescribed the drugs based on a drugâ€™s actual average selling price, plus 6 percent for handling. And indirectly â€” because of the time it takes drug companies to compile actual sales data and the government to revise the average selling price â€” it restricted the price from increasing by more than 6 percent every six months.
The act had an unintended consequence. In the first two or three years after a cancer drug goes generic, its price can drop by as much as 90 percent as manufacturers compete for market share. But if a shortage develops, the drugâ€™s price should be able to increase again to attract more manufacturers. Because the 2003 act effectively limits drug price increases, it prevents this from happening. The low profit margins mean that manufacturers face a hard choice: lose money producing a lifesaving drug or switch limited production capacity to a more lucrative drug.
The result is clear: in 2004 there were 58 new drug shortages, but by 2010 the number had steadily increased to 211. (These numbers include noncancer drugs as well.)
But wait, the Democrats and President Obama are now suggesting that price controls should be extended to Medicare Part D. I suppose that way we can enjoy shortages of all pharmaceuticals instead of just singling out cancer drugs.
Drug Shortages Need Addressing Now
The Burrill Report
” Letâ€™s start with the FDA.â€Â
All of a sudden the mainstream mediaâ€”highlighted by a much ballyhooed piece inÂ The New York Timesâ€™ Week in Reviewâ€”has discovered the problem ofÂ drug shortages. Unfortunately,Â itâ€™s not a new problem.
According to a recent analysis, the frequency and impact of drug shortages have risen to critical levels, more than tripling since 2005, and affecting all segments of the healthcare community. In 2010, more thanÂ 240Â drugs were either in short supply or completely unavailable, and more thanÂ 400generic equivalents were back-ordered for more than five days. In most instances, these did not progress to critical shortages, but point to instabilities in the supply chain that cause national concern. Many of the drugs identified in 2010 remain unavailable or in short supply in 2011.
SomeÂ 77 percent of drugsÂ in short supply in 2010 were sterile injectable products, critical in the acute care setting. Recent media coverage highlights the plight of patients and physicians faced with shortages for cancer drugs, anesthetic agents, and critical care medications that have contributed to delays in treatment and surgery or changes in care plans. Drug backorders cause patients to receive substitute therapies that add expense to patient care.
Quality and manufacturing problems are a major reason for shortages. However, there are other contributors, such as production delays and problems obtaining raw materials and components from suppliers. Discontinuations also contribute to shortages. The FDA can’t require a firm to keep making a drug it wants to discontinue.
It is time not to fix the blame, but to fix the problem. Letâ€™s start with the FDA.
In 2010, there were 178 drug shortages reported to the FDA. Is that a solid number? Itâ€™s hard to say, because current regulations do not require companies to notify FDA of shortages. The only requirement is that companies inform the agency six months in advance of discontinuing sole-source, medically necessary drugs.
For example, in the same year 38 shortages were prevented when companies voluntarily notified the FDA of potential issues that could lead to shortages, giving the agency an opportunity to work with the company to avoid a shortage.
The agencyâ€™s Drug Shortage Program (DSP) resides within the FDAâ€™s Center for Drug Evaluation and Research. The DSP was established to address potential or actual shortages of drugs that, “have a significant impact on public health”. (Who decides what the definition of significant impact on public health? If i am a cancer patient whose life is threatened by waiting for needed treatment, because a drug is not available, to me that is significant, to the FDA, maybe not so much. The same is true if I am individual that depends upon strong medications to treat chronic pain in order to have some level of functionality, and who, without those medications, is forced to suffer excruciating pain 24/7. To me, the inability to obtain those medications, very significantly impacts every aspect of my life. However, again to the FDA, the fact that I am unable to access the medications whether due to their availability, or due to the FDA’s ever increasing ridiculously long list of hoops my physician, my pharmacy and I (as the patient) must jump through in order to effectively control that pain, probably are of little significant importance to the FDA.) DSP works with pharmaceutical manufacturers, review divisions, compliance, and other components of the FDA to manage product shortages through communication, facilitation, and negotiation.
When the drug shortage is for a generic product (as it often is), the FDA works with other firms making the drug to help them ramp up production if they are willing to do so. Often they need new production lines approved or need new raw material sources approved to help increase supplies. The FDA can and does expedite review of these facilities to help resolve shortages of medically necessary drugs.
But the FDA can’t require the other firms to increase or commence production.
The agency tries to do the best it can with limited authority, spare resources, and shared staff. In addition to direct communication with industry, the DSP also gets reports from healthcare professionals, patients/individuals, or professional organizations using the e-mail address firstname.lastname@example.org. But, as you can imagine, there is not a lot of e-mail traffic. And there is no social media effort to promote either its purpose or existence.
The FDAâ€™s Drug Shortage Program is a good start. But itâ€™s not getting the job done. The problem is getting worse. The FDA needs both more authority and greater resources. In short, more needs to happen.
The Institute for Safe Medication Practices surveyed 1,800 healthcare practitioners, and found more than half of respondents frequently or always encounter difficulties associated with drug shortages.
The top three problems fall squarely within the zone of appropriate FDA attention and action. They include:
* Little or no information available about the duration of a drug shortage (85%)
* Lack of advanced warning from manufacturers or FDA to alert practitioners to an impending drug shortage and suggested alternatives (84%)
* Little or no information about the cause of the drug shortage (83%)
Â Survey respondents felt â€œunsupportedâ€ by the FDA and are perplexed regarding why the United States is experiencing drug shortages of â€œepic proportion that are often associated with third-world countries.â€Â
Should the issues of both authority and funding for the FDAâ€™s efforts to mitigate drug shortages be hung on the Prescription Drug User Fee Act Christmas tree as the legislation is renewed or addressed in separate legislation? Whether itâ€™s one or the other, itâ€™s an issue that must be addressed with urgency as it has now become a question of American lives.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.
Some of the More than 180 Drugs in Short Supply include:
Adderall (Attention Deficet Disorder)
Glucophage (metformin) for diabetes
Cipro (ciprofloxacin), antibiotic
Propofol, widely used anesthetic
Succinylcholine injections, a muscle relaxant used during surgery
Thyrogen (thyrotropin alfa), for thyroid cancer patients
Cytarabine, chemotherapy used to combat leukemia
Paclitaxel, a chemotherapy for breast, lung, ovarian cancers
*Penicillin: the granddaddy of antibiotics has been in use since the 1940s; it is used to treat certain infections ear, skin and throat infections
*Tetracycline: an antibiotic used to treat bacterial infections such as pneumonia and to kill the bug that causes stomach ulcers (Helicobacter pylori)
*Erythromycin: an antibiotic used to treat bacterial infections such as bronchitis, whooping cough and pneumonia
*Hydrocortisone lotion: a product used to treat various skin infections and rashes and the discomfort of hemorrhoids
Cephalexin: an antibiotic used to treat ear and skin infections;
Doxycycline: an antibiotic used to treat bacterial infections, such as urinary-tract infections and chlamydia
Metoclopramide (brand name Maxeran): a drug used to relieve heartburn and speed the healing of ulcers and sores in the esophagus in people who have gastroesophageal reflux disease
Heparin: an anticoagulant (blood thinner) used to prevent clots from forming in catheters worn by people with a number of conditions
Twinrix: a combination hepatitis A and hepatitis B vaccine
Amitriptyline (Elavil): a tricyclic antidepressant used to treat depression and pain from shingles
Prochlorperazine (Stemetil): an antipsychotic used to treat schizophrenia; it is also used to treat nausea and vertigo in cancer patients
Â nitrogen mustard,
Narcotic pain medications
Blood pressure Medications
In short, no one really has any answers. The Big Pharma companies blame the FDA, the FDA blames Big Pharma, the DEA is too busy selling guns to Mexican drug dealers, encouraging them to be walked across the boarder and hiding the fact that they are being traced back to violent crimes, including murder, committed in the United States.
When the DEA isn’t too busy with the FAST AND FURIOUS mess, they are occupied with placing incredibly restrictive rules, restrictions and laws on prescription drugs, the physicians prescribing them, and the unfortunate patients who need them.
This leads to Â making Â already very difficult, frustrating medical care for Â those who are chronically ill, and/or Â in pain, Â nearly impossible to navigate through or get the help available to ease their constant misery and pain . The physicians try what they can to use other more creative, less restrictive options and combinations, that inevitably Â result in dangerous and deadly mistakes.
Now back to that whole conspiracy theory thing… does anyone question the very real possibility that in one way or another, Obama’s Death Panels are already hard at work here?