mardi, novembre 25, 2008

You Hold Your Life In Your Hands With One Pill

After reading the two latest articles that I have posted about the "legal" drug industry, that is exactly how I feel. I have felt that way for some time, but it definitely re-enforces that fact... that I may literally be holding my life in my hands in taking the pharma drugs. It really does give you food for thought... doesn't it!!


AP IMPACT: Govt pays millions for unapproved drugs


By RICARDO ALONSO-ZALDIVAR and FRANK BASS, Associated Press Writers Ricardo Alonso-zaldivar And Frank Bass, Associated Press Writers – Mon Nov 24, 3:24 am ET

WASHINGTON – Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found. Millions of private patients are taking such drugs, as well.
The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.
The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s. The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.
The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold. The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA says there may be thousands of such drugs on the market.
Medicaid officials acknowledge the problem, but say they need help from Congress to fix it. The FDA and Medicaid are part of the Health and Human Services Department, but the FDA has yet to compile a master list of unapproved drugs, and Medicaid — which may be the biggest purchaser — keeps paying.
"I think this is something we ought to look at very hard, and we ought to fix it," said Medicaid chief Herb Kuhn. "It raises a whole set of questions, not only in terms of safety, but in the efficiency of the program — to make sure we are getting the right set of services for beneficiaries."
At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system.
Sen. Charles Grassley, R-Iowa, has asked the HHS inspector general to investigate.
That unapproved prescription drugs can be sold in the United States surprises even doctors and pharmacists. But the FDA estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year. Private insurance plans also cover them.
The roots of the problem go back in time, tangled in layers of legalese.
It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were "grandfathered" under earlier laws, and even under the 1962 bill.
Then, in the early 1980s, a safety scandal erupted over one of those medications. E-Ferol, a high potency vitamin E injection, was linked to serious reactions in some 100 premature babies, 40 of whom died.
In response, the FDA started a program to weed out drugs it had never reviewed scientifically. Yet some medications continued to escape scrutiny.
Sometimes, the medications do not help patients. In other cases, the FDA says, they have made people sicker, maybe even killed them. This year, for example, the FDA banned injectable versions of a gout drug called colchicine after receiving reports of 23 deaths. Investigators found the unapproved drug had a very narrow margin of safety, and patients easily could receive a toxic dose leading to complications such as organ failure.
Critics say the FDA's case-by-case enforcement approach is not working.
"The FDA does not appear to have a systematic mechanism to report these drugs out," said Jon Glaudemans, senior vice president of Avalere Health, a health care industry information company, "and there doesn't seem to be a systematic process by which health insurance programs can validate their status. And everyone is pointing the finger at someone else as to why we can't get there."
In most cases, doctors, pharmacists and patients are not aware the drugs are unapproved.
"Over the years, they have become fully entrenched in the system," said Patti Manolakis, a Charlotte, N.C., pharmacist who has studied the issue. Only a few unapproved drugs are truly essential and should remain on the market, she added.
Tackling the problem is made harder by confusing — and sometimes conflicting — laws, regulations and responsibilities that pertain to different government agencies.
Medicaid officials said their program, which serves the poor and disabled, is allowed to pay for unapproved drugs until the FDA orders a specific medication off the market. But that can take years.
Compare that with Medicare, the health care program for older people.
Medicare's prescription program is not supposed to cover unapproved drugs. Medicare has purged hundreds of such medications from its coverage lists, but continues to find others.
It might be easier to sort things out if the FDA compiled a master list of unapproved drugs, but the agency hasn't. FDA officials say that would be difficult because many manufacturers do not list unapproved products with the agency. Yet, the AP found many that were listed — a possible starting point for a list.
Among the drugs the AP's research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a decongestant, and ICAR Prenatal, a vitamin tablet. Medicaid data show the program paid $7.3 million for Carbofed products from 2004 to 2007; $146,000 for Hylira; $4.8 million for Andehist products, and $900,000 for ICAR.
Grassley said the system is failing taxpayers and consumers.
"The problem I see is bureaucrats don't want to make a decision," Grassley said. "There is no reason why this should be such a house of mirrors when so much public money is being spent." Grassley is considering introducing legislation to ensure that consumers are told when a medication is unapproved.
FDA officials say they tell Medicaid and Medicare when the agency moves to ban an unapproved drug, so the programs can stop paying.
"The situation is complicated by the fact that Medicaid and Medicare have a different regulatory regime than FDA does," said FDA compliance lawyer Michael Levy. "There are products that we may consider to be illegally marketed that could be legally reimbursed under their law."
The FDA began its latest crackdown on unapproved drugs two years ago and has taken action against nine types of medications and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized millions of dollars' worth of medications. But federal law does not provide fines for selling unapproved drugs, and criminal prosecutions are rare.
Some manufacturers of unapproved drugs say their products predate FDA regulation and are "grandfathered in."
"These are drugs that don't require an FDA approval," said Bill Peters, chief financial officer of Hi-Tech Pharmacal in Amityville, N.Y. "These are products with active ingredients that have been on the market for a long time." The company is moving away from older products, Peters said, and its new market offerings are FDA-approved.
Levy said the FDA is skeptical that any drugs now being sold are entitled to "grandfather" status. To qualify, they would have to be identical to medications sold decades ago in formulation and other important aspects.
The agency is targeting drugs linked to fraud, ones that do not work and, above all, those with safety risks. While the crackdown has helped, it does not appear to have solved the problem.
The gout drug banned by the FDA this February is not the only recent case involving safety problems.
Last year, the FDA banned unapproved cough medicines containing hydrocodone, a potent narcotic. Some had directions for medicating children as young as age 2, although no hydrocodone cough products have been shown to be safe and effective for children under 6.
In a 2006 case, the agency received 21 reports of children younger than 2 who died after taking unapproved cold and allergy medications containing carbinoxamine, an allergy drug that also acts as a powerful sedative. Regulators banned all products that contained carbinoxamine in combination with other cold medicines.
"We as Americans have a belief that all the prescription drugs that are available to us have been reviewed and approved by the FDA," said Manolakis, the pharmacist. "I think the presence of these drugs shows we have a false sense of security."

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lundi, novembre 24, 2008

Big Pharma's Pills Contaminated with Machine Parts at Pill Factories

by Mike Adams Originally published October 27 2008

(NaturalNews) An investigation by the Associated Press (AP) has uncovered evidence of widespread quality control problems in pills produced in Puerto Rico, a region that manufactures many of the prescription medications sold in America. Puerto Rico has one of the highest concentrations of pharmaceutical factories in the world, producing $35 billion worth of drugs each year. The United States, with its $300-billion annual drug market, is the island's primary customer, and 13 of the country's top 20 selling drugs are produced in Puerto Rico.

But an AP review of FDA documents finds widespread contamination problems at Puerto Rican pill factories, which have led to the export and sale of tainted and potentially unsafe medications. The documents reviewed concerned FDA inspections of 13 Puerto Rican factories between 2003 and 2007, accounting for approximately half of the pill factories on the island.

"People would be shocked to find this whole variety of contamination," said Sidney Wolfe of Public Citizen. "The common denominator of all these is there's really poor quality control."

This is especially interesting given that the FDA has acted to protect Big Pharma's monopoly drug pricing scheme in the United States by claiming that pills imported from Canada, Mexico or other countries might be unsafe due to contamination or poor quality control. Therefore, the FDA claims, American consumers should be forced to pay the highest prices in the world for drugs sold at monopoly prices in the United States. And yet we're now finding that even those drugs sold in U.S. pharmacies aren't manufactured here, and they may be even more dangerous than the same medications purchased from Canada.
Metal particles, door paint found in medication pills
Among the incidents identified in the AP review was a case where a worker sorting blood pressure pills for Biovail Corp. noticed blue flecks on the pills that matched the paint on the factory's doors. Eventually, the employee's reports led to the factory covering the drug carts, but no investigation was launched into whether contaminated shipments had gone out, and the incident was written off as a fluke.

"[The] incident was considered an isolated event ... even when the employee reported having observed the same particles before," the FDA report on the incident reads.

In another case, a plant owned by Teva Pharmaceutical Industries continued exporting drugs that it knew to contain small metal particles inside pill bottles or even embedded in the pills themselves. In addition to being aware of conditions inside the factory, the company had received at least six consumer complaints about the pills.

When challenged by the FDA, the company's quality control unit said that the presence of metal in the pills was normal, because the plant's machinery was made out of metal!

The plant closed two months later. As in most similar cases, the company denied any connection between the defective pills and the factory shutdown.
Machine parts ground into medication pills?


In May 2006, after patients complained of finding machinery pins inside pill bottles of Wyeth's depression drug Effexor and heartburn drug Protonix, the FDA sent a warning letter to the factory in question, asking why the plant was not "able to detect that the affected equipment was missing some of its parts."

Not all cases involved foreign materials. In March 2005, the FDA raided a Puerto Rican GlaxoSmithKline plant after receiving reports that pills of the antidepressant drug Paxil CR had split apart, making it hard for patients to calculate proper dosages. In that raid, agents found tablets of the diabetes drug Avandemet that contained improper dosages.

The FDA has been criticized for failing to monitor the drug industry well enough to make sure that such errors do not occur, or that they are corrected more quickly. Critics point out that the FDA often fails to act until several incidents have occurred.

The agency says that it dislikes challenging companies after only one incident, because it is hard to prove that the problem is systemic, as seen in the incident of the paint-flecked pills, which Biovail claimed was a fluke. (Quiz time: How many flukes does it take to make a pattern? FDA answer: There are no patterns. They're ALL flukes!)

The FDA inspects each factory in Puerto Rico approximately once every two years, by the way. That's one day out of 730 days.

By the way, wasn't it the FDA that urged Americans to not buy pharmaceuticals from Canada or Mexico because they might not be safe? Apparently swallowing ground-up machine parts from a pill factory in Puerto Rico is safer than buying quality-controlled pharmaceuticals from Canada, if you ask the FDA. Then again, maybe they're just trying to protect the U.S. pharmaceutical monopoly.
The pills are dangerous even if they're manufactured correctly
What these outrageous quality control problems bring to light is the fact that pharmaceuticals are dangerous to your health on two levels: First, there's the risk of harm or death caused by the drugs themselves, even when they are properly manufactured and consumed. Around 100,000 Americans are killed each year by FDA-approved prescription drugs, according to research conducted by the American Medical Association.

But now, there's a whole new level of risk: Contamination at the factory. With medication pills possibly containing machine parts, pieces of metal, paint and other contaminants - and the utter lack of proper FDA oversight of these factories - it presents yet another good reason for consumers to find natural alternatives to dangerous prescription medications.

These pharmaceutical pills that are contaminated with metal parts and other chemicals do serve one purpose, however: They make patients sick, bringing them back to the hospital where they are almost certain to be prescribed yet more prescription drugs sold by the very same companies the manufactured the contaminated pills in the first place. Repeat business, anyone?

(reprint from www.Natural News.com)

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mercredi, novembre 19, 2008

Attack of the Tiny Nano Particles - Be Slightly Afraid

Attack of the Tiny Nano Particles - Be Slightly Afraid
Report calls for more tests on 'wonder ingredient'
By Ian Sample
The Guardian / UK, November 15, 2008
Straight to the Source


Proliferation of nano materials could pose risk

The government must begin a "major and urgent" effort to assess the safety of nanomaterials, the tiny particles commonly used in products as varied as sun creams, sports clothing and medicine, leading experts warn today.

Hundreds of consumer products made with nanoparticles, which can be 100 times smaller than a virus, are already on the market, despite an almost complete lack of knowledge of the dangers they may pose to human health and the environment, according to a report by the royal commission on environmental pollution.

Nanoparticles have been embraced as a wonder ingredient across manufacturing industry. Cosmetic companies add titanium dioxide nanoparticles to sun creams to make them transparent instead of white. Sports clothing firms have introduced odour-free garments containing nanosilver particles that are twice as toxic to bacteria as bleach. The motor industry has added carbon nanofibres to car tyres and body panels to strengthen them. Many nanomaterials are so poorly understood that scientists are unable to predict how they will behave, and are unclear even how to check their safety, the report says.

Sir John Lawton, who chairs the commission, said the lack of tests and environmental monitoring for nanoparticles meant it was impossible to know if the materials were already a cause for concern. "Would we know if nanomaterials were causing harm? The answer is, no we wouldn't. We have no evidence that they cause harm, but a lot of that is because of a lack of evidence," he said. Professor Sir John Lawton on need to test nanotechnology Link to this audio

Industry figures estimate at least 600 products are already available globally that contain nanomaterials of some form, but that figure is expected to rise steeply.

The report warns that the proliferation of nanoparticles will see more of them released into the environment where they could be inhaled, discharged into water courses, and potentially introduced into the food chain with unknown consequences.

Lawton acknowledged nanoparticles were "exceedingly useful", but said there was "a major gap between the pace at which new nanomaterials are being developed and the generation of environmental health and safety data". Some scientists who gave evidence to the commission said it could be 20 years before sufficient safety measures were in place to monitor nanotechnology. "We don't want to be alarmist, but experience says the more we find out about this the better," said Lawton. "We're saying [to the government] get your finger out and get on and do something. This is really urgent."

Last week, the Royal Society expressed its dismay at the government's lack of action following its own report on nanotechnology in 2004, which also called for more stringent safety checks.

Nanoparticles lend their success to the extraordinary, and sometimes highly unusual, properties they have. For example, carbon nanotubes are incredibly strong, while pieces of graphite easily sheer apart. Nanoparticles of silver are significantly more toxic than lumps of the metal because the tiny particles have a huge surface area. The medical industry is investing heavily in nanoparticles to create precision drugs that can target specific tissues, such as cancer cells.

The report calls on government departments to back immediate research into toxicity tests for nanoparticles and the impact of nanomaterials in the environment.

The commission picks out three types of nanoparticle it says are of particular concern. Highly toxic nanosilver will inevitably get into the water supply when sports garments incorporating silver nanoparticles are washed. These could cause problems at sewage treatment works, which rely on beds of bacteria to purify water. Carbon nanofibres, which can be added to car tyres or woven into clothing to produce different colours without using dyes, are likely to be shed into the environment where they could be inhaled.

Finally, "buckyballs" - microscopic football-shaped cages of carbon - can be absorbed by simple organisms, according to the report, raising concerns that they could contaminate the food chain.

A spokesperson for Defra said: "As the commission states, it has found no evidence of harm to health or the environment from nanomaterials, but the government remains committed to researching their health and environmental impact." Backstory

Eric Drexler, an American engineer sketched the scenario whereby nanomachines no bigger than molecules run amok, consuming the planet's resources and leaving nothing but grey goo, in his 1986 book Engines of Creation. He has now dismissed that view, but more realistic concerns remain. Nanotechnology encompasses any material suited to measurement in billionths of a metre, or nanometres: connections in a chip, fibres in a tennis racket, or particles absorbing UV light in suntan lotion. Nanoparticles behave unlike lumps of the same material - stronger, more toxic, and with radically different electrical properties. What makes them so useful also makes their safety so uncertain.

© Guardian News and Media Limited 2008

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A New Direction

It has been a while since I have posted anything here and I have decided to go a completely new direction in my posts. As I am involved in selling health products and come across amazing information, I have decided to start sharing the articles that I find exceptionally informative. So, Stay posted.....

Posted by Papillon :: 10:06 AM :: 0 Comments:

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