The Bad, the Ugly and Disturbing Look at Our Medication Regulatory System

Small, medium, large and white: many times people have come in contact with medication that will cure us - or so we thought. Welcome to the 21st century, where everything that you know or knew about your medication before is false.

Is our prescription medication all ‘pure and untainted’? I thought so, but then I was hit by a reality check. In the article linked below, the author was in need to buy Sudafed or what is also known as Pseudoephrine HCL. Sudafed is a sympathomimetic amine and it is commonly used as a decongestant. Since, nowadays, this drug is used to produce methamphetamine it is tightly regulated by pharmacies – so much so, that the author of the original article needed to give two pieces of ID before he was able to purchase it. I have gone through this many times while buying medication – checking IDs, prescription (if I have it or need it), summarizing how the drug is used, telling you to read the label before using it, etc. which led me to believe that our chain of pharmacies must be super cautious and safe. I was not the only one fooled to believe this. Rick Vassar (original author) was surprised to find out that the situation with pharmaceutical companies is much more complicated than that and that what he believed in for the past years of his life was false. It turns out that your prescription does not guarantee anything at all. Furthermore, it might be making you sicker than you are right now. Pharmacies Rick Vassar assumed the following three points (as any other US citizen would): 1. Pharmaceutical companies manufacture medications. 2. These medications are shipped to pharmacies through regulated distribution. 3. Tightly controlled distribution ensures quality and prevents adulteration. And guess what? He was wrong, I was wrong and everybody else who assumed this was wrong. According to the information he gathered, there is an estimated 400 – 6,000 wholesalers who sell and buy medications. The prices of these drugs increase if stockpiling occurs (which occurs often). When prices increase, medications are released – however, there is little or no regard for safe storage or expiration date. What is worst of all, medications are repackaged and resold to pharmacies across US. Now you might look at your medication box and say: “Wait a second. My expiration date is not old. It says it will expire on some day, some month, 2009. It’s not yet 2009!” Well, guess what? The drugs are repackaged and expiration dates are changed to new ones. I guess that little, white pill is not as old as you thought! Also, there have been instances when drugs were not repackaged or stored properly, which caused the chemical components to break down, rendering the drug useless or ineffective (best case scenario) or potentially harmful or deadly for the consumer. Is your head starting to hurt yet? Wait. There is more. Remember those commercials for Viagra, Cialis, etc that you find all over the internet and newspapers? You think they are unreliable and you would never think of buying any medication like that, right? Well, then you’re up for a surprise because you might just be ‘popping’ yourself with these kinds of medications – the ones you find potentially dangerous. Not just that! You might be buying them right from your pharmacy. In February 2003, this was confirmed by the [url=http://64.233.167.104/search?q=cache:mPYqUyXydcEJ:www.dangerousdoses.com/pdf/grandjuryreport.pdf+First+Interim+Report+of+the+Seventeenth+Statewide+Grand+Jury+(Florida+Case+SC02-2645)&hl=en&ct=clnk&cd=1&gl=ca&client=firefox-a t=_blank]First Interim Report of the Seventeenth Statewide Grand Jury (Florida Case SC02-2645):

[The movement of drugs]up, down and sideways through the distribution system… creates opportunities for adulterated drugs that have been diverted from other sources to enter the system.”

The Case of Cardinal Health Three major pharmaceutical wholesalers exist in the US: Cardinal Health Inc., McKesson Corp., and AmerisourceBergen Corp. According to the research done by Mr. Vassari, the state of New York attorney general’s office subpoenaed all 3 wholesalers in 2005. In the agreement reached between the Attorney General of the State of New York Medicare Control Unit and Health Care Bureau, Cardinal Health had to pay $11 million dollars. However, the findings of the agreement were alarming. The agreement showed that Cardinal actually knew or should have known about the adulterated drugs that entered the system, but did not take any steps to ensure that distribution of medication is safe. This is very ironic, because if you click on their website, the first message you will see is: “Making healthcare safer and more productive.” But wait… Maybe they think they are doing us a favour by selling this medication. Parts of the agreement state:

‘…In March 2004, Cardinal realized it possessed an anabolic steroid product that customers might perceive as high risk… It sought to avoid such customer concerns by transferring this product from its trading company, which was known for buying from ASV’s to its ‘divisions’ which customers perceived as selling pharmaceuticals purchased from manufacturers. A Cardinal employee sent an e-mail to the head of the Trading Company, noting a substantial inventory in ‘an anabolic steroid that is on the restricted list due to potential counterfeit. There is plenty of room to pass this product to the divisions. What are your thoughts on moving this product to the divisions? The reply e-mail instructed simply: ‘Go ahead and move it.’

‘From May 2001 through May 2002 ‘Cardinal purchased drugs on the Secondary Market that later turned out to be counterfeit… over 10,000 units of counterfeit Procrit… Cardinal, still unaware that the product was counterfeit, sold some of the counterfeit Procrit to its customers…’

‘…Cardinal repeatedly sold pharmaceuticals to customers that it knew or should have known were diverting pharmaceuticals… Cardinal made numerous sales of pharmaceuticals to a Nevada company which purported to be a ‘closed door’ pharmacy that served only nursing homes. In a routine pattern, the Nevada company placed two orders at the same time. One was for products likely to be needed by the stated… nursing home residents… The other was for much higher quantities and included products unlikely to be needed by nursing home residents… Investigation has shown the company dispensed the products on the small-quantity orders to nursing home residents and it transferred the products on the large –quantity orders to an affiliated wholesaler for resale on the Secondary Market.’

‘Cardinal made ‘third party’ returns to manufacturers on behalf of other wholesalers regardless of where the wholesaler had purchased the product… Such practices support the Diversion Market by giving unscrupulous customers an incentive to divert drugs and then ‘return’ them for full credit…’

In press release on December 26, 2006, then Attorney General, Eliot Spitzer stated:

‘The investigation determined that Cardinal purchased drugs from certain alternate source vendors, despite risks associated with buying from those vendors, to take advantage of higher available profit margins. Cardinal also sold pharmaceuticals to certain customers even in the face of evidence that those customers may have been illegally diverting the drugs outside their intended channels of distribution…’

FDA Situation According to Rick Vassari, House Committee on Oversight and Government Reform released a report in June 2006 which was entitled Prescription for Harm – The Decline in FDA Enforcement Activities. Take a look at the very much disturbing evidence and results of this report:

1. FDA enforcement actions have declined under the Bush Administration. The number of warning letters issued by the agency for violations of federal requirements has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low. During the same period, the number of seizures of mislabeled, defective, and dangerous products has declined by 44%.

2. FDA headquarters officials have routinely rejected the enforcement recommendations of career field staff. Internal agency documents show that in at least 138 cases over the last five years involving drugs and biological products, FDA failed to take enforcement actions despite receiving recommendations from agency field inspectors describing violations of FDA requirements.

3. FDA’s record keeping and case tracking practices are inadequate. Although the Federal Records Act and internal agency procedures require FDA to keep records that document agency enforcement decisions, FDA does not appear to comply with these requirements. FDA’s response to Committee requests for relevant enforcement documents was haphazard, incomplete, and untimely. FDA officials explained that FDA could not provide prompt and complete responses because the agency lacks a system that enables it to track enforcement recommendations from field offices.

So, what does FDA do for USA pharmaceutical chain? Well, it has basically 2 purposes. Firstly, it is supposed to license and approve new medication and devices. Secondly, give violations and warnings. Over the years evidence has piled up that FDA’s enforcements for safe medication have decreased. Before it used to take them approximately 13.2 months to approve a drug – nowadays it usually takes 6 months or less. So, what now? The nonprofit group called Prevent Medical Error has stated that pharmacies, patients, and prescribers are rarely alerted by FDA when something goes the wrong way. According to Vassari, pharmaceutical companies do not need to alert all of the above to FDA inquiries or warnings. And that is the main problem – they only alert their stockholders. All in all, it is very disturbing to know that FDA can have secretive conversations with their manufacturer. Furthermore, it is inappropriate and unconscionable that they do not think of the proper safety measures needed to protect the public as also go over their heads to hide the information from us. It has been proven over and over that FDA cannot be trusted. Furthermore, they are not reliable (also proven recently). Oh, yes, not to forget: if you want them to explain why something occurred be ready to wait for a long time. You will not get an answer and even if you do, it will be a total lie. If you want them to back you up on something, you are in for the wait of your life – FDA would rather back up pharmaceutical companies than you. But wait a second – US lawmakers did say that FDA is doing a great job and that they are going to award the agency with even more money, did they not? The bill in question is called Enhancing Drug Safety and Innovation Act of 2007. The bill basically increases FDA’s management power, joins the government with drug companies to make profit off of US citizens and pretends to address safety issues. Furthermore, the public, as soon as this goes into effect is left in the dark not knowing what kind of drugs they are buying, where the drugs came from or who regulated safety measures of this medication. This bill acts as a smokescreen for the public. I mean, the whole point of FDA is to distract the public into thinking one thing and then take away their health privileges and freedom. Or am I reading it wrong? Safe and therapeutic drugs are going to be allowed to be removed from the shelves and replaced by new and untested powerful biological drugs which can be and should be considered disturbing – the public will become nothing more than laboratory rats participating in a very sick and diverted experiment. As for knowing how good our drugs are: we are probably never going to find out. Moreover, we will probably never know whether the medication we are taking came from a reliable source, was manufactured, distributed and dispensed in compliance with any regulations because of the nature of this and many other companies out there. Most likely, we will be taking medication that is unreliable and not safe. While people are dying from many mistakes pharmacies already make when giving out certain medications, unwanted and unreliable pharmaceutical chains are just blooming. In fact, right now, the owners of these companies are probably sitting somewhere, drinking their martinis, looking over at the Gulf of Mexico, smiling and waving at us. My question to you is: should we allow FDA, government and other drug companies to take over our lives and control us like lab rats? Next time you decide to take that little pill, put it in your mouth and drink it, ask yourself: where did this come from because in the near future, if nothing is done, you will not have that privilege either. Further Research: http://www.newstarget.com/021824.html http://www.newstarget.com/021819.html http://www.newstarget.com/021811.html