Thursday, September 27, 2007

School House Rock: The Drug Development Edition

Good afternoon, y'all! I'm going to whisper this because I know some idiot sub-lebrity will screw this up but this week's programs have been really interesting. Great mix of topics, good interviews and great pace. I'm so glad that Anderson and his graphics team were just being snarky the other night. While the pre-commercial graphics like "He's not kidding, its really short!" were hysterical, they wouldn't be appropriate night after night!

And of course, you gotta love Anderson's bong comment! Okay dude, I believe you! Yeah right! LOL! I told this story briefly in Phebe's comments this morning but I'll elaborate just to embarrass my wonderful yet naive mother! Now, hand to God, I have never even smoked a cigarette let alone partake in some of the more herbal wonders of life. But I do know what a bong looks like. My roomate in college had a collection of them! My parents brought me home one weekend during my freshman year at college. Well, needless to say, when we walked thru the door on Sunday, my roomate was no where to be found but her bongs were! My mother walked over to her side of the room, picked up the bong and said, "Wow! What an unusual looking vase! Where did she get it?" My father and I looked at her and burst out laughing. That story has been affectionately recalled at almost every family gathering for the past 15 or so years! Sorry Mommy! I had to tell it again!

Playing by the rules in the pharma world
Gary Tuchman's story didn't set well with my husband and I last night for different reasons. First I must tell you that I have spent over 12 years in the Pharmaceutical/Biotech industry and know full well that dealing with the FDA is like banging your head against the wall. The agency is antiquated, understaffed and mismanaged. My husband also works in the industry. However, his role in his company represents the new technological age of the FDA.

Gary said that the FDA has only recently cracked down on these companies but that is not entirely true. Let's take our friend Mr. Malik from Syntho Pharmaceuticals and Intermax Pharmaceuticals. He has been manufacturing and marketing unapproved cold products for quite some time. Gary mentioned that he has felt the "sting" of the FDA. That is true. The FDA lodged it's first warning letter to Malik in March 2003. They issued another letter in May 2003. The FDA then filed a complaint for a Permanent Injunction in August 2006. The FDA also sent a letter out on October 5, 2006 about the injunction of Syntho and other letters it had sent out to additional companies also in violation of the same sinister practices. *

Malik calls himself "I'm a man of integrity," and said that he is "...morally obligated to give you a product that is good." Yet he doesn't believe that the drugs he manufactures should have to be put through the rigorous tests that are required of every pharmaceutical drug and instrument used in this country. Here is what he said about following those nasty rules:

Malik said he believes concerns about unapproved drugs are overblown. He thinks the FDA's testing procedures are too expensive and cumbersome for small companies like his. And despite the lack of FDA approval, Malik said he's not ashamed of his drugs and believes some of them should be brought back to market. (AC360 Transcripts)

While what Malik says about the drug development process being expensive is true, there is a reason why these drugs are put through toxicology, pharmacology, pre-clinical and clinical trials. I'm not sure many people know that it is a long road that a drug must take before it hits the your pharmacies. (Hee, this is like the School House Rock for the drug development process just for your own personal knowledge!) It takes roughly 10-12 years and nearly $1 billion dollars to complete the process. But the pre-clinical and clinical trial period are imperative in the drug development process to ensure that the drug is both safe and effective for each indication it is being prescribed for. Just ask Jacque Gibson White who lost her precious baby because the hospital used an unapproved drug on her precious baby, Rachel Ann. How incredibly sad.

The FDA has in fact been trying to crack down on these companies since 1995, as in the case of Sage Pharmaceuticals. No doubt the agency has a long way to go to get it's act together. For one, they could release that list of unapproved drugs and give it to physicians and pharmacists. But I must tell you that it is probably impossible to account for all of these drugs. And even if this is done, it will not stop doctors from off-label prescribing (a whole different problem). So while I agree with most aspects of Gary's report, I must argue that the FDA should not take full blame for these unapproved marketed drugs. These companies knowingly manufacture unapproved products and sell them to major pharmacies. They know how to use the FDA flaws to their advantage and their illegal practices compromise the public's safety.

Now, why was my husband bothered by Gary's report? Well, he isn't sure that the use of NDC codes was properly explained. Think of an NDC Code as a registration code of sorts. A New Drug Application is filed with the FDA and is assigned this 10 digit code. Each part of the code has a meaning. (I won't further bore you with that info!) This code is more of a registration code than an approval code. That's where my DH was a bit unhappy. In the report, the FDA was getting blamed for these unethical companies twisting the rules to fit their illegal practices. Like Gary said, an NDC code is not an approval code but a tracking or identification number at best. (Well, I just simplified it for you. It is that and so much more.) So again, while I agree that the FDA needs to be proactive and change the way they assign NDC codes so that these companies cannot manipulate the system. But I must argue here that we should also be keeping these irressponsible companies honest, not just the FDA. All responsible pharmaceutical companies play by the rules. These rogue companies find a way to manipulate the broken system to get their products on the shelves.

Listen, I truly believe that reports like Gary's are important so that the public can be aware of these practices. We need to be diligent and question our physicians. We need to do our research to protect our children and ourselves. Unfortunately, it might be along time before the FDA is an efficiently run organization. But I felt like the report aimed it's cannon directly on the FDA and didn't stress that companies like Syntho Pharmaceuticals should share the blame. And I didn't even mention physicians who don't research the products they agree to prescribe in the first place!

*Click here for all data concerning Syntho Pharmaceuticals Warning and Injunction Letters and other FDA letters.

Two more appearances for Anderson Cooper
Anderson moderated a panel at yesterday's session of Clinton's Global Initiatives. The session was entitled, “The Most Effective Strategies for the Most Vulnerable Children.” Click here for video of the panel session.

Also, Anderson Cooper will be speaking at Claremont McKenna College on November 13th at 11am. Click here for more details or go to the Anderson Cooper Event's Calendar.

Thanks for your time today! It's a subject that is close t my heart! Have a great weekend! ~Sheryn


Sapphire said...

Sunday School Rock....I love it. Sheryn your post was very fascinating and between your post and Gary's report, I have learned alot.

It is really cool that Anderson was part of the Clinton conference. Worked out so Anderson could get a one-on-one with Clinton himself.

Sheryn, your mom sounds too cute. that was a great story :)

Great screen caps too :)

Anonymous said...

I just love your story about your Mom and the bong, Sheryn. I just got back from my vacation and kept thinking of all of you including Anderson about the bong. I went to Morocco and everywhere I went, there are many type of bongs that kept in the Cafes and inside the hotels. One of my group wanted to buy it but not allow to bring it to USA. But what do you think calling for in Morocco? It's not exactly called "Bong" Can anyone of you know the exact name for it?

Since I got back last weekend, I missed the whole 360 show. But I did watch some including the interview with Clinton. I never knew that Clinton had that anger side. Surprisely, Anderson looked so calm.

I have been going over with your ATA and the blogs (back where Anderson was in Iraq). Did Anderson have a cold or flu when he was in Iraq? Because at the same week as Anderson was, I was in Morocco. The several of my tour group had a flu-like symstom. They had experienced with fever and virus. I think due to the climates change or something else in Africa and Middle East may have caused it. I still have a cold since I got back from my vacation.

Please let me know if it is true that Anderson was ill during his trip.

Hearing impaired gal

sydney said...

Due to some heavy duty s&!# going on in my life right now, I've had to skip watching the show this week (though I have snagged a few peeks at some podcasts and this blog). Sounds like it was bad timing :-(

Pixiedust said...

Sheryn, thanks for the background! My best friend for the last 43 years is going through her fourth fight with cancer. First was breast cancer, second was breast cancer on the other side, but it masticized to her lungs...thus the third round of cancer. Each treatment was a life and death fight. Chemo almost kills her each time. But the third fight was particularly harsh. The naseau and vomiting was taking it's toll. Fortunately, she is a fighter and used each opportunity to search the internet for new ways to make the experience a little better. They discovered there was a study group for a new drug for cancer patients suffering with naseau that was delaying their treatment.

She was only given 5 years after the lung cancer, but here it is 3 years later and she has been hit with uterine cancer. She made it through the hystorectomy, but this time they were trying a new chemo, one that we all prayed would make it easier for her...but, sorry, I'm having trouble with understanding why God would test a sweet woman who has never done anything but try to help others.

This time is worse than ever before. She got the chemo Tuesday and by Sunday she was admitted to the hospital with fever, convulsions, etc. She is worse than ever before, she is on several antibiotics and morphine, yet still wretching in pain. It breaks my heart.

I'm torn about the amount of time it takes to get drugs through the system. As a patient who went through 3 treatments of a weight loss medication that left me with a heart murmur and a grandmother of a 2 year old who has been on steroid breathing treatments for over a year, I'm worried about what long-term effects this may have.

However, as a friend who's cancer treatment has been delayed and who's challenged body is being ripped apart by chemo, I'm begging that there is some wonder drug that is in the 10-12 year cycle that can be accessed to make a difference between her living and dying.

Unknown said...

Wow, Pixie, I'm so sorry to hear about your friend. I hope things work out.... it's heartbreaking. I pray she gets through her treatments ok.

Phebe said...

Maybe you and Tuchman sould do a point-counterpoint kind of thing. You could take totally take him.

Sheryn said...

Dude, I'd crush him like a bug! NO, just kidding! I love Gary! I just thought this particular story didn't really take aim at ALL the guilty parties. I didn't even go into how and why the doctors prescribe these drugs and the "gifts" they receive for meeting quotas!

I also didn't even touch on Off-Label prescribing practices. In doing research for this story, I too found out that I was given an unapproved drug during Labor. Duramorph is NOT an approved drug for Labor and Delivery but they put it in my epidural for my c-section.

Now, Duramorph is an approved drug but not approved for Labor and Delivery. That is what they call off-label prescribing. You gotta be careful with how these doctors give out certain meds because really you might be getting an approved drug used for the wrong illness.

Each time a company finds that a specific drug works for a different indication (or illness) that drug company must go thru the clinical trials for that indication before it is approved to be prescribed.

And you know all those supplements in your fave Health Food store and your vitamins? Not FDA approved. Nope!

There's so much that wasn't covered in this segment and it could really be an AC360 special recurring segment. Your Doctor/Your Health! How's that for a CNN proposal? LOL!

Come on, Sanjay should know this stuff cold! ;)

Sheryn said...

Pixie, I'm so sorry to hear about your friend. My thoughts and prayers go out to her. What a horrible thing to go thru.

I'm sure it is completely heart-breaking to watch a loved one slip away while promising meds are making their way thru the approval process. I have been privy to watching awesome researchers (good kind caring people) work for years of their lives to develop these compounds only to hear 10 years later that the drug did not get approved becasue of adverse events or efficacy issues. It is tragic truly tragic.

Clinical trials are out there for patients who really truly want to get a jump on those experimental meds. There are of course goods and bads to these studies but researching which studies are available and applicable is one proactive thing you can do for her.

I pray that your friend finds a miracle cure. I truly do.