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My Profit Is Worth More Than Your Safety

October 13, 2012

Medicine shows were traveling horse and wagon teams which peddled “miracle cure” medications and other products, between various entertainment acts.  Shaman have been pitching miraculous cures since classical times because they have access to, and influence the world of benevolent and malevolent spirits

Today, Shamans (Product Marketers) have access to, and influence the world of Big Pharma (the Great Spirit) corporations who are becoming more and more like early century “Snake Oil” salesmen. Their entertainment for you, is advertisement.

Today’s product can be just as questionable as Snake Oil mixed in the back room.  Yes, many “over-the-counter” medications are very helpful for several ailments.  But, the big bucks are betting they can convince you to ask your doctor for their specific formula to treat your specific condition. Ask the drug manufacturer if their profit is worth more than a few lives. Marketers schmooze your doctor with payoffs and goodies to prescribe their drug, after they introduce it to you in cute advertisements. 

Big Pharma pulls the strings of the lawmakers and regulators.  FDA, at the mercy of Big Pharma, cannot aggressively enforce existing laws and regulations that keep the Pharmaceutical Industry honest. Integrity has been discarded along with safety.  Compounding is the unregulated version of Big Pharma. You probably never heard of the “Compounding” process until it became responsible for the recent MultiState Meningitis Outbreak.

What used to be plain and simple advertisement for a product has become a science on population manipulation.  The goal of producing medicine, faster and cheaper, is to make millions of dollars before any problems are discovered. The normal is unenforced regulation used by corrupt business practices in America. “Large-scale compounders often behave like manufacturers, complete with sales teams that market their products to doctors. And they do not have to abide by the F.D.A.’s regulations, which require that problems with products be reported to the agency. In effect, he said, the companies are circumventing the regulatory process”.

FDA took 684 days to warn meningitis-linked firm: files

BOSTON (Reuters) – The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering serious issues at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents showed.

The New England Compounding Center (NECC) chastised the FDA for taking so long, telling the agency its response time was nearly 18 months longer than the FDA’s average response, according to letters released by a Freedom of Information Act request from Reuters.

Deadly meningitis outbreak was completely avoidable

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This week’s extravaganza is the deadly meningitis outbreak. Oh my! 

Contaminated injections started on May 21, 2012. The product was recalled on September 26, 2012 An expanded voluntary recall of all NECC productsExternal Web Site Icon, was announced October 6, 2012..

CDC Responds to Multistate Meningitis Outbreak

   Multistate Outbreak of Fungal Infection Associated with Injection of Methylprednisolone Acetate Solution from a Single Compounding Pharmacy — United States, 2012

The scare has prompted multiple investigations, and New England Compounding Center, has recalled the product and suspended operations. 

HIPAA Compliance for Reporters to FDA MedWatch.

Frequently Asked Questions For Patients: Multistate Meningitis Outbreak Investigation

 

Related articles:

FDA: Pharmacy’s other drugs may be causing illness

NEW YORK (AP) — Two more drugs from a specialty pharmacy linked to a meningitis outbreak are now being investigated, U.S. health officials said, as they urged doctors to contact patients who got any kind of injection from the company.  The FDA on Monday expanded its advice to doctors to contact all patients who got any injection made by the company, including steroids and drugs used in eye surgery as well as heart operations. The agency said it took the step “out of an abundance of caution” as it investigates the new reports involving the heart surgery drug and the second steroid, called triamcinolone acetonide.

Meningitis-linked firm sold drugs without prescriptions: emails

BOSTON (Reuters) – The drug-mixing company at the heart of a deadly U.S. meningitis outbreak solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations, emails to a customer show.  Reuters reviewed more than a dozen emails that show the New England Compounding Center, contrary to state rules, sold drugs without requiring physicians to supply individual patient prescriptions.

Another Death Reported in Meningitis Outbreak

Another person has died from fungal meningitis linked to possibly tainted vials of a steroid medication, bringing the death toll in an outbreak to 15, the Centers for Disease Control and Prevention said Saturday.  … The number of people stricken in the outbreak reached 197 on Saturday, up 13 from Friday, the center reported. In addition, there is one case of an infection after an injection in an ankle that has not been confirmed as meningitis.

New England Compounding Sued Over Shot Meningitis Risk

New England Compounding Pharmacy Inc. was sued by a woman who received a steroid shot that was recalled because it was potentially contaminated with a fungus putting recipients at risk for meningitis.

The lawsuit in federal court in St. Paul, Minnesota, was filed by Barbe Puro, who received injections of the steroid methylprednisolone acetate, made by Framingham, Massachusetts- based New England Compounding, to ease chronic back pain, according to the complaint.

Ex-Workers at Firm Tied to Pharmacy Had Safety Fears

BOSTON — One pharmacist said she quit because she was worried that unqualified people were helping prepare dangerous narcotics for use by hospitals. A quality control technician said he tried to stop the production line when he noticed that some labels were missing, but was overruled by management. A salesman said he and his colleagues were brought into the sterile lab to help out with packaging and labeling during rush orders, something they were not trained for.

… because of pressure to increase output, there were a couple of “near misses.” One was when hydromorphone, a powerful narcotic, was made at twice the potency by a pharmacist who was working late to try to achieve production numbers for the day. The error was caught, however, before the bags left the plant.

The emphasis was always on speed, not on doing the job right,” said the quality control technician who tried to stop the production line and who said he was eventually fired over disagreements about safety. “One of their favorite phrases was ‘This line is worth more than all your lives combined, so don’t stop it.’ ”  Both employees attributed the pressure to increase production speed to an aggressive new operations manager focused on the bottom line.

Meningitis outbreak: Massachusetts agencies ‘failed to enforce regulations’

State agencies face questions over enforcement of existing regulations covering compounding pharmacies.  Authorities in Massachusetts have been accused of failing to properly enforce regulations aimed at protecting patients from contaminated drugs, after the death toll from an outbreak of meningitis linked to a medicine made in the state rose to 14.  The specialised compounding pharmacy at the centre of the escalating health scandal is being investigated for breaches of state and federal laws.

US Pharmacopeia (USP), the industry body behind regulations governing compounding sterile drugs. “If someone just enforced Massachusetts law, these cases could have been avoided. They failed in their responsibility for enforcing what they already had.” … Each case has prompted calls for federal oversight of the drug-producers, which are not subject to the same controls as mass manufacturers but whose regulation falls between the state board of pharmacy, the state department of health and the Food and Drug Administration, which regulates the pharmaceutical industry.

Scant Oversight of Drug Maker in Fatal Meningitis Outbreak

…  some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies.

“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” said Kevin Outterson, an associate professor of law at Boston University.

… the International Academy of Compounding Pharmacists, estimated that large-scale compounders represented about 10 percent of all compounding pharmacies, but he could not say what percentage of compounded medicines they made.

As state and federal authorities pored over information about New England Compounding last week, there was little agreement among experts on whether the company broke the law by making products in bulk and shipping them around the country.

Compounding falls in a legal no man’s land, between the federal government and the states. The F.D.A. regulates manufacturers, but compounders register as pharmacies, putting them under a patchwork of state rules. The F.D.A. did develop a clear set of rules for compounding, but subsequent litigation that culminated in a Supreme Court decision in 2002 struck them down, and Congress never re-established the agency’s clear authority, Professor Outterson said.

Unfortunately, the list of recalled pharmaceuticals is always vague, litigated and often hushed up.  Always check the CDC and FDA for updates.  There is a reason for that. The ongoing Multistate Meningitis Outbreak was identified in May 2012, but the recall did not happen until September 26, 2012.  Wonder why it took so long?  Could it be that the company makes $2.2 million a year doing what it does best, mass produce a high demand product.  Pain management is a profitable business …  How many fatalities could have been avoided?.

The FDA’s mission is to protect and promote the public health.  However, Pharmaceutical Lobbies create too many roadblocks against enforcing laws and regulations that keep manufacturing ethical and safe. Those roadblocks change priorities to profit over safety.  A few lawsuit settlements are so much cheaper than changing manufacturing techniques that focus on quantity and speed of production instead of quality and inspection. 

FDA October 12, 2012 4:00 PM EDT -  Background:
The Centers for Disease Control and Prevention (CDC) with state and local health departments and the Food and Drug Administration (FDA)External Web Site Icon are investigating a multistate meningitis outbreak of fungal infections among patients who have received a steroid injection of a potentially contaminated product into the spinal area. This form of meningitis is not contagious. The investigation also includes fungal infections associated with injections in a peripheral joint space, such as a knee, shoulder or ankle.

Economic Impact Analyses of FDA Regulations

The Food and Drug Administration conducts economic analyses of all important proposed and final regulations. Each economic analysis includes an assessment of the costs, benefits, and cost-effectiveness of the action, as well as assessments of the costs, benefits and cost-effectiveness of the most promising alternative actions. The full economic impact analyses of significant FDA regulations are no longer (as of April 2012) published in the Federal Register but are available on this site.

To compare the effects of proposed regulations with the effects of promising alternatives, we estimate both the incremental benefits and costs associated with increasing the stringency of regulation and the incremental foregone benefits and cost savings associated with decreasing the stringency of regulation.

The information on incremental costs and benefits helps FDA management choose which controls to include and which to exclude when presented with the usual smorgasbord of ways to deal with a public health problem. The economic analysis may also point out ways to increase the cost-effectiveness of regulation. For example, the economic analysis may demonstrate that the incremental costs associated with a particular provision are very high, with little or no incremental public health effects. Identifying such provisions enables the FDA to revise proposed regulations in ways that substantially decrease costs without appreciably reducing public health benefits.

Factbox: Meningitis outbreak spotlights pharmacy practice

The F.D.A. could invoke the Food, Drug and Cosmetic Act of 1938, which makes it a criminal act “to introduce into interstate commerce an unapproved drug.” That is what New England Compounding’s products would most likely be considered because the company was doing more than traditional compounding, yet had not obtained a new drug approval, something that large drug makers spend millions of dollars and years to get.

The list of food borne contamination with Salmonela and eColi outbreaks in America, for the past few years, is very long. Food Borne recalls are only slowed down by lobbyists. Waterborne outbreaks reported in the United States are relatively quick because they are mostly community based.  Healthcare-associated Infections (HAI) are slow to be identified and reported. The hospital lobby is powerful. Paid representatives of large pharmaceutical and biomedicine companies in the United States  seek to influence federal government policy. There is a world wide organization devoted to cleaning up the drug and pharmaceutical industry: The Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel from more than 50 of the largest research-based pharmaceutical manufacturers.

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 2,700 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding.

There are associations, agencies and professional commissions who hold regular conferences devoted to keeping the pharmaceutical and drug industry honest and safe.

THIRTEENTH ANNUAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUM

FIFTH ANNUAL SUMMIT ON DISCLOSURE, TRANSPARENCY AND AGGREGATE SPEND FOR DRUG, DEVICE AND BIOTECH COMPANIES – February 19 – 21, 2013

SEVENTH INTERNATIONAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUM – May 21 – 23, 2013

FOURTEENTH PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS  -  October 28 – 30, 2013

So next time you hear a politician say he wants to deregulate industry, you must decide what are you willing to give up!  If you expect safe medications, safe food, safe products for your children and a proper education so you can make informed decisions, then regulations are what protect you.  Deregulation is just another way for industry, including the health care industry, to take shortcuts and skimp on quality to provide quantity and profit.  Remember, employees were told that “This line is worth more than all your lives combined, so don’t stop it”.

Ask your favorite candidate if deregulation will really make us all better off.  The answer seems to be a resounding NO!

Corporate Corruption is Status Quo in the United States. Laws and regulations go unenforced, because the enforcement agencies have been depleted by past administrations. Too few regulators is like too few firefighters for a wildfire.  Someone will always get burned …  Regulations protect everyone and will cost a little more, but, at least you can live long enough to complain about it.

If you are in pain, ask a lot of questions.

(CNN) – The ever-expanding outbreak of life-threatening fungal meningitis in back pain patients linked to steroid injections prepared by a compounding pharmacy, which so far has sickened at least 214 people and killed 15 in 15 states, is a public health catastrophe. What is particularly tragic for those who have been sickened or killed by the tainted drug and for their loved ones is that this situation was completely avoidable. … it has used “enforcement discretion” to allow compounding pharmacies to produce these drugs without complying with FDA regulations, generally deferring regulatory oversight to state pharmacy boards.

… the New England Compounding Center in Framingham, Massachusetts, one of many compounding pharmacies across the country that has crossed the line between traditional compounding and large-scale drug production. The injectable steroid medication produced at the center was never approved by the FDA and was not manufactured in accordance with the FDA’s rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

Loud alarm bells were sounded on December 4, 2006, when the FDA issued warning letters to the New England Compounding Center and four other compounding pharmacies, directing them to stop producing standardized versions of medications that, according to the agency, were being “marketed for general distribution rather than responding to the unique medical needs of individual patients.” the center was cited for violations of FDA regulations in marketing four different drugs, including repackaged doses of the cancer drug Avastin into syringes for treatment of macular degeneration.

… the FDA attempted to deflect criticism for its failures by asserting that it lacked authority to take action earlier. This flies in the face of the agency’s long-stated position that it had legal authority over such activities and its prior enforcement activities against the New England center and multiple other compounding pharmacies. While no one wants to be viewed as being responsible for a preventable public health catastrophe, American citizens should express their outrage and demand that all parties responsible for this tragedy — including the FDA — be held accountable.

You must ask your elected Congress Representative or Senator how much money it saved, the American Budget, to cut funding to regulatory agencies and reduce the ranks of inspection and enforcement. Ask your elected representative how any agency is expected to take enforcement seriously, when Congress dismisses the importance of regulations.  Ask your elected representative why they fight so hard to deregulate industries that impact the American Public.  Medical and Health Care has become a Ponzi Scheme that does not appreciate the human lives they put at risk with their greedy techniques.  When quantity takes priority over quality, people die.

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