breaking away from the superficial and the transient - p2

FDA, are three letters that can make most pharmaceutical companies cringe.

Capable of regulating all food and drug industries in the U.S., the FDA is a government funded agency that "protects and promotes American's health."

For the purpose of this blog, we'll focus on just the drug part and the role the FDA plays in getting a drug to the market. Drugs that are currently sitting in pharmacies have all been FDA approved. They have survived hundreds of tests and made clear their worth to the health of the American people. 

But drug approval is not always so black and white. There are certainly grey areas filled with ethical dilemmas and questionable issues. And the FDA is the sole regulator in deciding where the lines are drawn.

If you've ever wondered how a drug gets approval for market sale, you've come to the right place. I have wondered it myself. Looking into market approval, the most important aspect is for a drug to be consumer safe. The drug is put through a number of clinical trials to tests its effectiveness and find most if not all possible side effects resulting from the drug. The more that is known about a drug the better the likelihood of chemists perfecting it. And if you've ever read articles on drug approval you would see how vital clinical trial results are to securing support from the FDA. 

However, as I read through articles describing the clinical trials of drugs like Ceravix for HPV and PXL4032 for melanoma cancer I've found very questionable results. The drug trials produced numerous unexplained diseases and complications for trial patients. More specifically the articles raised serious issues regarding the FDA's cancer trial designs. 

In Central Valley, California, two cousins developed almost identical forms of melanoma skin cancer. One cousin entered the drug trial lottery and showed success under the use of PXL4032, while the other cousin entered the chemotherapy treatment that became fatal. These boys however were not given the opportunity to chose their trials. Had they been given that option, both boys would be alive and well today instead of just one. Due to FDA drug trial regulations requirement of a control test group, a needless fatality occurred. This poses serious questions for the FDA and their drug trial policies. The more articles I come across the more faults I find in patient drug trials. Although drug trials are typically for patients with no other alternative, it is not meant to shorten the lives of those who are hoping for a treatment or cure. And yet I keep coming across tags similar to: development of cancerous cells, abnormal heart rates, herpes infection, liver disease, and so on. 

And of all the articles I have sifted through, I haven't found one that openly questions the credibility, reliability, and overal integrity of the Food and Drug Administration. From the looks of it, the FDA is playing God. Their decision is the only one that matters, and although their main goal is to "protect and promote American health" the real question is: How competent is the FDA?

We need to tear away the layers of all the shiny new drugs that are currently saving lives, and look deeper into all the lives it did take because at one point it was prematurely tested on patients, or because the FDA's stupid requirement of a control group that cost the life a boy in Central Valley, California. 

Is the FDA of substance, or are they just this superficial government agency used to make it look like the U.S. has drugs under control? 


I'm going to find out.

-J

a bit of light reading - sample anno.

You do the crime. You pay the time. Or in this case the fine. 

Forest Pharmaceuticals is facing over $300 million dollars in fines and penalties for undermining the rules and regulations of the Food and Drug Administration. From distribution of an unapproved drug to the misbranding of medication Forest is currently under immense scrutiny.

The drug that started this witch hunt was Levothroid, or levothyroxine, an unapproved drug used to treat hypothyroidism. Levothroid by Forest actually has a long standing history to before 1997. At the start of 97' the FDA enacted a new policy that would require the drug to be re-approved if the manufacturer intended on continuing the marketing of the product. However, because Levothroid was labeled a necessary drug, the FDA allow temporary use of the drug until it was phased out which was to occur before August of 2003. But like any normal human being financial gain obscured their judgement. Forest Pharm did not begin phasing out their drug, instead they increased production. 

Celexa was the second mistake Forest had to own up to. Used as a serotonin reuptake inhibitor for adults, Forest began branding the drug for the pediatric units in hospitals. The promotion of Celexa for children has not be approved by the FDA and therefore Forest was charged with an additional count of misbranding medication.

You may ask what took the FDA so long to crack down on Forest's misconduct. Well, according to the 2003 FDA inspection Forest employees provided false statements regarding Levothroid and Celexa. And as a result Forest is now charged with their last count of impeding an agency proceeding. 

In total Forest Pharmaceuticals, and their mother company, Forest Laboratories, will be paying a $164 million dollars in criminal penalties and an additional $149 million dollars to relieve a civil suit with the Office of Inspector General of the U.S. Department of Health and Human Services. 

If you're worried about all the people currently on Levothroid, there's no need. The FDA would never let an unapproved drug sit on the market to wait the outcome of a court case. The Levothroid currently under scrutiny was yanked off the shelves and re-submitted for FDA approval which is eventually received. It is now compliant with FDA regulations. 

Its reassuring to know the FDA has a system that requires even large corporate companies to follow. And luckily the drug was caught early enough to prevent fatalities. If patients had died, Forest would be facing more than just a few million dollars in fines. 

-J

how the little guys stay afloat - open.

Large chain pharmacies like CVS and Walgreens are popping up at every corner. They are expanding at such an accelerated rate its hard to say one is more convenient than the other when they are both five minutes away. In addition there are also the Target's, Walmart's, and even supermarkets like Ralph's that are incorporating pharmacies into their stores. As they promote the idea of "shop while you wait for your prescription," it is pulling prescription filling patients in every direction. But while these companies are marking their territory other "Mom & Pap" pharmacies are being forced to close their doors. 

The little guys just can't compete. 

With large retail companies like CVS branching out in every direction very few of the smaller family owned pharmacies can sustain. According to BNET, there are currently 30 large retail pharmacy chains in the Unite States and the top five are none that we haven't heard of before: Walgreens, CVS, Rite Aid, Wal-Mart, and Albertsons. In addition, the number of 30 retail chains is not getting any smaller. Local pharmacies are really struggling to survive. But that's not to say that they have all disappeared, some amazing few have made it through this rough patch. 

Of those rare few, Llyod's Remedies of Lousiana is standing proud. They were recently acknowledged by the National Community Pharmacy Association for their "dedication to community pharmacy." - utilizing the concept of a tight niche to keep their customers coming back.

They've adapted and are changing the face of pharmacy and the pre-existing notion of doctor patient care. 

Lloyd's Pharmacy is finding new ways to provide excellent service to their customers. From in home deliveries to custom prescriptions they are tailoring the pharmacy to the needs of the patient. As we enter this age of technology, they have also implemented refilling prescriptions online and are providing real time medication profiling. Relying on community support, a friendly staff, and personal service Lloyd's Pharmacy is proud to celebrate 10 years of business. 

From the looks of it, there will be many more to come. 

-J

Trio

Hello World.

So tell me, what do you think J&J should do about that recall scandal? Fight or flight? Or maybe what is the next best step Pfizer can take with their failed miracle PTSD drug? Invest more or just chuck it and start over?

Now imagine sitting in a room before a panel of people trying to b.s. your way out of those questions at a graduate school interview or even job interview. And while these people are waiting for your well thought out response; there's people outside just waiting for you to choke. But what can you say when you have no idea what the heck the J&J scandal is, and wasn’t even aware Pfizer had a PTSD drug on the market.  Well then it’s going to be a long, awkward, and uncomfortable interview. These people, they’re testing you. They want to know just how caught up you are with the current events in today’s health care industry, after all that is what you are trying to get into. And if you can’t produce some witty intelligent response, then you should be ashamed. Entering a field you know nothing about? I suggest you better get started on those search engine runs.

Or. You can stay, and let me make your life that much easier.

Filter. Filter. Filter.

I will be sifting through every search engine you can possibly think of looking for the most interesting, most relevant, and most important articles to write about; recalls, drug violations, ethics versus financial gain and so on. But more importantly, I’m not going to just hurl information at you. Instead, I will be focusing on relevant events—drawing on academic inferences to keep you in the loop. You may ask, what makes me qualified to write? Well, at least I’m aiming for my bachelors in science and I also know how to answer the J&J and Pfizer questions. Which is probably more than I can say for you. But no need to worry. You’ll be an expert before you know it. This will be the first blog you come across that caters to… well, anyone who wants to know what’s going on in the world really, but more specifically, students and young professionals in or entering the health sciences. And also just people who want to have intelligent and insightful conversations about drug companies and how they have turned healthcare into a multi-billion dollar capitalistic industry. But most of all, I’ll save you the trouble of running head first into a profession you know absolutely nothing about.

This is going to be your one stop shop to keep up to date on the current events in the pharmaceutical industry. And if you decide to follow up on my daily reports you will have so much more to say, you’ll blow your colleagues away and you just might decide to start your own blog, like me.

-J

Not your typical kind of GOSSIP

After 19 years on the market, Avastin by Genentech will face its final scrutiny on September 17^th. On that Friday the FDA will tell Genentech either they have wasted millions of dollars in breast cancer research or applaud them with the long waited approval of a new drug to the market. No one really knows what the FDA will decide- sometimes I wonder if the decision is made as they walk through the doors of the conference room.

But in any case, this story is exactly the type of thing that keeps me coming back to Pharmagossip, short and sweet interesting updates on what is happening with some of the drugs on the market. Although pharma gossip seems like an outsider to the pharmaceutical world, his insights are thought provoking and material rare. His articles are very uncommon, and definitely pieces I wouldn’t come across when running around in yahoo or google. And the best feature of pharmagossip is his ability to update frequently (as frequent as a few posts in a single day). It seems in the last decade Avastin went through several clinical trials and received approval from the FDA to be administered for colon and lung cancer treatment. Toying with possibilities of treating other cancers, Genentech began thinking of administering Avastin for breast cancer treatment. However FDA officials welcomed this decision with a lukewarm reception only granting “accelerated temporary approval.”

And what is “temporary approval“ even suppose to mean? Use the drug now, but enjoy the side effects of near death experience later? Well, that is just ridiculous. Unfortunately, the FDA’s decision is the only decision that matters, so I hope for the sake of all the mothers, sisters, and friends out there, the trials and testing goes well. I’ll keep my fingers crossed on Sept. 17^th.

          Now let’s turn our heads to some of the politics faced in this industry of ethics and morals versus financial gain. Less than two weeks ago Dr. Joseph Hammag defended himself and Pfizer against allegations of swindling. A conference was arranged solely to discuss the so-called unavoidable illegal activity that sometimes take place in the drug industry. Here’s the CliffsNotes version of the white-collar crime. Drug reps from pharmaceutical manufacturers scout out doctors and essentially anyone with a prescription pad and persuade them to prescribe drugs for treatments that have yet to be approved by the FDA. And what’s in it for the doctors you say? Well, their bank accounts mysteriously receive a new cash flow that cannot be explained by their fixed annual salaries. But anyhow, what I ultimately wanted to say is thanks PharmaGossip, for letting me know the pharm industry has some pretty morally bankrupt individuals. I’ll do my best to steer clear of them next year.

            Intellectually stimulating and a great attention to detail are just a few ways I’d describe PharmaGossip. While gossip probably not, I’d argue entertaining and informative. As I begin my own blog, I intend to use Pharmagossip as a starting foundation. I’ll add things here and there, and take away some of the unnecessary fluff. I would also probably go with a more personal touch and express my opinions with more bang. After all, responses to my spiel would be quite exciting.  And I’ll attempt to cater to a larger audience and not just the stay at home moms and unemployed.  Maybe I’ll even make it to Technorati. Just you wait.

            -J

Voice. Speak and be Heard.

The average Joe with a relatively average IQ would probably not find long monotonous articles interesting to read. And yet the average Joe seems to be part of the audience I am aiming for. So how do I get Joe to read what I write? How do I get him to read through not just the first few lines but also be able to tolerate the rest?

Well, I can always mesmerize him with my voice.

There are emotions I wish to convey in my writing, and certain responses I hope for in return. I want to cultivate intimacy while maintaining a certain amount of anonymity when Joe goes through my posts. As I sift through pharmacy related blogs on the web I have come some across several forms of writing. Some bloggers prefer to use vulgar and crude language to invoke a feeling of authenticity, while other writer’s refrain from using profanity at all costs. They incorporate more sophisticated and witty expressions to communicate their emotions. I find the analytical and refined blogger’s use of idioms and play on words very clever and exciting to read.   

Ultimately wit outperforms slang.

The first thing that caught my attention on Pharmablogger was the play on words in the title “Do you recall..?” Instead of assessing your memory ability the writer actually meant, “recall,” as in the long disgusting process of taking back from the consumer what was already sold to them.  More specifically she was alluding to the recall of “Johnson & Johnson / McNeil’s Tylenol products.” She immediately jumps right into the article and provides not one but several links to her sources to establish her credibility. Then as you scroll through the post you will find she highlights the points of the recall and spices up her post using exclamations like “WOW!” The WOW was referring to the $820 thousand J&J saved by switching bottle suppliers. I WOW-ed too.  To top it off, she closes up her post with witty sarcasm -  

“So if you’re a J&J stockholder, you might want to let him know how much you appreciate the savings, unless you think the (currently) estimated $1.2 billion in lost sales…, overshadow that $820 large.”

If I were a J&J stockholder, I’d be bitching about the $1.2 billion dollar loss, and could care less about the $820 thousand saved.

Next we should consider the post “Not a good week for AZ….” Pharmablogger finds yet another way to keep Joe attentive. Plain language. In her post she uses a single complex sentence and a block quote while skipping out on the use of similes and metaphors. She writes: “Astra Zeneca loses patent case against Dr. Reddy’s, and then has to cough up court costs.” I’m not sure if you caught that, but “cough up” is a clever way of saying pay up. Her use of just one sentence to describe the courtcase is simple and refined.  What I liked most was her use of a block quote, and how she titled it “my favorite passage.” She personalized it to ensure us she is not just a robot behind a desk regurgitating what she finds. She actually has a mind of her own.

When I picture Pharmablogger I get the image of a white-coated middle-aged woman sitting at a lab desk surfing the web. Her unique writing style combined with her quick remarks makes her blog interesting and easy to read. It keeps Joe sitting at the edge of his seat wanting more.

-J

Voice. Speak and be Heard.

I’ve only just start blogging these past few weeks, but within this time I have been desperately trying to find my own voice and style of writing. There are emotions I wish to convey and certain responses I hope to extract from my readers through my posts.  There is a certain feeling I want my reads to have as they read through my posts. And as I sift through other pharmacy related blogs on the web I have come some across very extreme forms of writing. Some bloggers prefer to use vulgar and crude language because they feel it makes their posts appear more “real.” But I have also seen blogs in which the writer refrains from using profanity. They incorporate more sophisticated and witty expression to communicate their emotions. Both of these blogs kept me interested in their postings, but by way of two different voices in their blogs. I could relate to the blog that contained more slag and informal speech simply because I felt like I was having a conversation with the writer. But I found the analytical and refined blogger’s use of idioms and play on words very clever and interesting to read as well.   

Ultimately wit outperformed slang. So we should put our hands together for Pharmablogger’s clever use of the English language. The first thing that caught my attention on Pharmablogger was the play on words in the title. “Do you recall..?” Well, I don’t know, do you? Not that it really matter’s because that is not what Pharmablogger meant. She meant “recall,” as in the long disgusting process of taking back from the consumer what was already given to them.  More specifically she was speaking about the recall of “Johnson & Johnson / McNeil’s Tylenol products.” Then she jumps right into the article and provides not one but several links to her sources for the post. And soon after she highlights the points of the recall and spices up her post using exclamations like “WOW!” when commenting on the ridiculous amount of money J&J saved by switching bottle suppliers.  Last, but not least she closes up her posting with a sarcastic tone by saying how if “[we] [were] J&J stockholders, [we] might want to let [them] know how much [we] appreciate the savings.” But in reality most of us are not J&J stockholders, and could care less they saved by switching suppliers.

Then in another post Pharmablogger completely changes her word choice and style in sentence structure. Rather than using puns and sarcasm the “Not a good week for AZ…” post utilizes a single complex sentence and a block quote. There is no use of similes or metaphors in her complex sentence just an independent clause connected to a dependent clause by way of a comma. Pharmablogger writes: “Astra Zeneca loses patent case against Dr. Reddy’s, and then has to cough up court costs.” Her use of just one sentence to describe the courtcase is what I call simple and refined. And in the dependent clause she added her own voice by using colloquialism to convey the idea that this is probably not the first time AZ lost a court case and needs to pay lawyer dues.  The thing I liked most about this specific post was her use of a block quote, in addition to providing concrete evidence to her post she personalized it by titling it “my favorite passage.” It let me, the reader; see her point of view on the court case.

Pharmablogger’s unique writing style combined with her quick remarks makes her blog that much more interesting to read. But that doesn’t go to say blogs that are less refined are of less value. I believe that a balance between the two is where my blog will stand. Use of occasional profanity would be a great tool when emphasizing a certain emotion and if combined with clever statements and observations the blog would appear “real” and sophisticated.  

Not your typical kind of GOSSIP

After 19 years on the market, Advastin by Genentech will face its final scrutiny on September 17^th. On that Friday the FDA will either tell Genentech they have wasted millions of dollars in breast cancer research or applaud them with an ultimate pay day. No one really knows what the FDA will decide, sometimes I wonder if the decision is made as they walk through the doors of the conference room.

But in any case, this story is exactly the type of thing that keeps me coming back to pharmagossip, short and sweet interesting updates on what is happening with some of the drugs on the market. Although pharma gossip seems like an outsider to the pharmaceutical world, his insights are thought provoking and material rare. His articles are very uncommon, they are definitely pieces I wouldn’t come across when running around in yahoo or google. And the best feature of pharmagossip is his ability to update frequently (As frequent as a few posts in a single day). It seems in the last decade Advastin went through several clinical trials and received approval from the FDA to be administered for colon and lung cancer treatment. Then before you knew it, Genentech jumped on the bandwagon of breast cancer treatment with Advastin. But hit a roadblock when the FDA only “granted accelerated temporary approval.”

What?! What does “temporary approval“ even mean? Use the drug now, but enjoy the side effects of near death experience later? That is just ridiculous. Well, ultimately the FDA’s decision is the only decision that matters, so I hope for the sake of all the mothers, sisters, and friends out there, the trials and testing goes well. I’ll keep my fingers crossed on Sept. 17^th.

          Now let’s turn our heads to some of the politics faced in this industry of ethics and morals versus financial gain. And I mean LOTS of financial gain. Less than two weeks ago Dr. Joseph Hammag defended himself and Pfizer against allegations of swindling. A conference was arranged solely to discuss the so called “unavoidable” illegal activity that “sometimes” take place in the drug industry. Here’s the cliff notes version of the white collar crime. Drug reps from pharmaceutical manufacturers scout out doctors and essentially anyone with a prescription pad and persuade them to prescribe drugs for treatments that have yet to be approved by the FDA. And what’s in it for the doctors you say? Well, their bank accounts mysteriously receive a new cash flow that cannot be explained by their fixed annual salaries. But anyhow, what I ultimately wanted to say is thanks PharmaGossip, for letting me know the pharm industry has some pretty morally bankrupt individuals. I’ll do my best to stay clear of them next year. Also, I loved the picture of the old white man with the guilty looking smile, very cliché and very politically correct too.

            Intellectually stimulating and a great attention to detail are just a few ways I’d describe PharmaGossip. But gossip probably not, I’d argue entertaining and informative. As I begin my own blog, I intend to use Pharmagossip as a starting foundation. I’ll add things here and there, and take away some of the unnecessary fluff. I would also probably go with a more personal touch and express my opinions with more bang. After all, responses to my spiel would be quite exciting.  And I’ll attempt to cater to a larger audience and not just the stay at home moms and unemployed.  Maybe I’ll even make it to Technorati. Just you wait.

Hello World.

So tell me, what do you think J&J should do about that recall scandal? Fight or flight? Or maybe what is the next best step Pfizer can take with their failed miracle PTSD drug? Invest more or just chuck it and start over?

Ever wonder how in the world you are going to b.s. your way out of those questions at your graduate school interview or even job interview? There are 2 to 3 or maybe even a room full of people staring at you waiting for your well thought out response. And then there’s the room full of people outside waiting for you to f*** up. But what can you say when you have no idea what the heck the J&J scandal is, and wasn’t even aware Pfizer had a PTSD drug on the market.  Well then it’s going to be a long, awkward, and uncomfortable interview. These people, they’re testing you. They want to know just how caught up you are with the current events in today’s health care industry, after all that is what you are trying to get into. And if you can’t produce some witty intelligent response, then you should be ashamed. Entering a field you know nothing about? I suggest you better get started on those search engine runs.

Or. You can stay, and let me make your life that much easier.

Filter. Filter. Filter.

That is exactly what I am going to do for you. I will be sifting through every search engine you can possibly think of looking for the most interesting, most relevant, and most important articles to write about; recalls, drug violations, ethics versus financial gain and so on. But I’m not going to spell it out in essay form, because otherwise you can just google the articles yourself. I am going to talk to you, literally. We’ll have our own conversations and inside jokes about what goes on with our healthcare industry. You may ask, what makes me qualified to write? Well, at least I know how to answer the J&J and Pfizer questions. Which is probably more than I can say for you. But no need to worry. You’ll be an expert before you know it. This will be the first blog you come across that caters to… well, anyone who wants to know what’s going on in the world really, but more specifically, students and young professionals in or entering the health sciences. And also just people who want to have intelligent and insightful conversations about drug companies and how they have turned healthcare into a multi-billion dollar capitalistic industry. But most of all, I’ll save you the trouble of running head first into a profession you know absolutely nothing about, which is like most newly grads.

This is going to be a blog that I’ve been searching for but never found. And if you decide to follow up on my daily reports you will have so much to say about the pharmaceutical industry you’ll blow your colleagues away and you just might decide to start your own blog.