Dating back to 1978, the FDA has twice been asked to remove propoxyphene (better known as the brand name Darvocet) from the market due to risks of heart abnormalities that could be and have been fatal. 32 years later, we have action. As of Friday 11/19/2010, the FDA has agreed to remove it from the US market. The pain medication was especially popular in the US, as over 10 million people have received prescriptions for it over the last year alone.

This admission of danger comes in typical cryptic FDA fashion though. Their statement recommends doctors to stop prescribing the medication, though they encourage patients to continue taking it. They also stated that “the drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.” If the risks are so serious, then why would they recommend patients currently taking it to continue to do so?

Popular opinion in the medical community suggests that the drug has been so widely prescribed due to its long existence. Since when does something being the oldest make it the best though? Far too often, medications are prescribed out of comfort. This can frequently leave patients with chemical dependency on these drugs long after their pain has subsided. Prescription drug abuse has been on the rise in recent years, and the real shame is that alternatives to drugs like darvocet are primarily stronger and potentially more addictive ones like morphine and oxycodone.

Furthermore, the delay in removing drugs like this goes to show that the FDA often doesn’t even trust their OWN advice. Last January, an advisory committee inside the FDA voted 14-12 to discontinue marketing the drug. That vote was vetoed by the FDA as a whole, and pill popping went on, business as usual.

Also of importance, when the ban was finally instated here in the US it was announced that a 30 year old study on the drug showed high levels of toxicity. More than 1,000 people have died in the US alone from use of this drug since 2005. That was the year it was banned in the UK.

For some time now certain retail products have carried microchips that were traceable via GPS in the idea that it would provide market information to manufacturers. The next generation of this idea has now surfaced, and its far more personal than letting Kellogg’s know exactly where you prefer to eat your frosted flakes. The next big thing that big brother has devised is implanting microchips in prescription drugs. These chips are activated once exposed to stomach acids, and then begin to transmit data to a patch worn on the skin about the size of a bandage. Wait, it gets weirder. Once data is received by the patch, it can then send information about the time and date the medication was ingested as well as vital signs and bodily functions at the time of ingestion via blue tooth technology to a cell phone. People will also have the “option” of having this data sent directly to their doctors, who can then spend their time making absolutely sure that we all take our pills.

While it may seem like a good idea at first, like in most cases there is more than meets the eye. According to the report by Rueters, manufacturers of these chips do not plan to conduct any clinical trials or tests whatsoever. If it is to transmit data of this nature over an encrypted network, then the question also arises of what sort of power source these chips will use. Upon last check, components of batteries or capacitors are toxic and should never be ingested. It also calls more questions into invasion of privacy, as the likelihood of government agents carrying scanners for these chips is a fairly reasonable assumption. They could likely be picked up by scanners in mass transport systems as well, adding another invasion of privacy to the already invasive “naked body scanners” that the TSA is using in US airports these days. That could win you an all expense paid trip to cavity search island, in full accordance with their new “enhanced pat down” policies of course.

The biggest problem is that putting microchips in pills like this doesn’t really benefit the patient so much as it does the pharmaceutical companies. They may potentially lose millions because of patients who forget to take their pills, and with this addition their doctors can stay on top of them and make sure they continue to load up on drugs Doctor knows best, after all.

Vitamin B.  You’ve known of it, and likely taken it for years.  Whether through the foods you eat, or as a separate supplement, it’s a part of your life.  It supports metabolism, maintains skin and muscle tone, enhances your immune and nervous systems, and promotes cell growth.  It all sounds wonderful, doesn’t it?  So what could be so bad about it that the FDA is ruling that some varieties be pulled from the shelves and not sold as dietary supplements?  It’s not expensive enough.

Pyridoxamine is a compound that makes up vitamin B6.  It has been readily available, and easily sold for years upon years as a dietary supplement. Up until now, there has been no news about it.  Even now, the news that does exist is somewhat under the radar, which is why we’re bringing it to you now. In 2005, a pharmaceutical company called Biostratum began developing a new drug to treat diabetic kidney disease. The only hitch in the plan came when investors in the company found that the only active ingredient in this new drug (Pyidorin) was pyridoxamine.  Pyridorin had already gone through two phases of clinical trials, so by now they’ve reahed the “nothing is off limits, anything goes” phase in order to get their drug through.

After this revelation they lost funding for their third phase of clinical trials, even though the first two had been successful. Success that was due mainly to the inclusion of an existing dietary supplement. What to do now? Change the formulation? Rethink the original strategy? Ban the previously sold, naturally occurring supplement altogether? If you guessed the third option then you could probably secure a position in Biostratums board of directors because that’s exactly what they’re doing. Biostratum is fighting to ban all previously existing forms of pyridoxamine and labeling them as “adulterated”.

Citing no explanation for this adulteration, the request has taken plenty of time to fester and become exacerbated.  However, earlier this year the FDA ruled that pyridoxamine can no longer be sold and their direct comment on the issue was “To allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.”

This is just another example of big government agencies being more concerned with filling their pockets than with the job that has been set before them.  The last time I checked, the FDA was still under the US Department of Health and Human Services.  It doesn’t seem that they’re serving all that appropriately.  Consider also that the FDA has recently called for Cheerios cereal to remove their advertisement that it can lower cholesterol unless it applies for a drug patent.

If you feel that behavior of this caliber is detrimental to our establishment and human rights, then your only real option is to file a citizen petition.  There are a few important things to remember when doing so.  They include:

1. 
   A description of the action you want addressed, such as a ruling or an order you want to have put in place, rewritten to include changes or revoked.
2. 
   The legal grounds on which you are making a petition and the facts to back up your claims. You do need to include all the supporting information that you can come up with.
3. 
   If your petition is one for which you are requesting approval of drugs, food additives, medical devices or for a food to be categorized as safe for consumption, you will have to provide information regarding the environmental impact of such a request.
4. 
   All petition letters must include the name, address and telephone number of the person initiating the petition.

The FDA does not accept emailed or online petitions, so once you have everything in order you can mail it to them at the following address:

Dockets Management Branch, HFA-305
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852