Biological Drugs Produce Side Effects But Vaccines Don't?

Managing Editor's Note:  This article says, "The drugs are known as biologicals because they're made from living material and they typically affect the body's disease-fighting immune system." Doesn't that sound similar to vaccines? I'll look forward to the comments.

CHICAGO - Nearly a fourth of widely used new-generation biological drugs for several common diseases produce serious side effects that lead to safety warnings soon after they go on the market, the first major study of its kind found. Included in the report released Tuesday were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor. All wound up being flagged for safety. That might surprise some doctors who may have thought that these new treatments might be safer than traditional chemical-based medicines.

   
Researchers found that most of the warnings came within five years after these biologicals won government approval in the United States and Europe between 1995 and 2007. Many traditional medicines wind up with safety warnings too after they go on the market. But experts said there were no similar studies of older medicines that made it possible to compare safety issues between the two groups of drugs. The new study, by Dutch researchers, is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution.

The drugs are known as biologicals because they're made from living material and they typically affect the body's disease-fighting immune system. Many relieve severe symptoms by suppressing that system. It's that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, said Dr. Charles Bennett, a Northwestern University drug safety expert. These can include brain and fungal infections and cancer.
   
Many are genetically engineered and Bennett said that because they typically resemble naturally occurring proteins, many doctors have assumed they were safer than traditional chemical-based medicines. But he said the study shows that's not necessarily true. "They have an important role," Bennett said. "They're really the next generation of pharmaceuticals."  He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.
   
Among the drugs under examination are Genentech Inc.'s psoriasis drug Raptiva, which just last week the Food and Drug Administration warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.  The study appears in Wednesday's Journal of the American Medical Association.
   
It involved 136 biologics approved in the United States and 105 in the European Union between January 1995 and June 2007. A total of 41, or nearly 24 percent, got safety warnings issued through June 2008. The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, said lead author Thijs Giezen of the University of Utrecht.
   
But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm. "If most issues are discovered within the first few years, then the system is working," Giezen said.  Bennett says it's unreasonable to think that the studied drugs' safety issues should have been discovered before they were marketed. That's because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.
   
Many biological drugs have advantages over conventional medicine, but the study shows their risks need to also be considered, said Thomas Moore of the Institute for Safe Medication Practices. For example, non-steroid arthritis medicines including ibuprofen can reduce pain by decreasing inflammation, but they can cause stomach bleeding.
   
Biologic rheumatoid arthritis medicines Remicade, Enbrel and Humira are designed to ease painful joints by keeping the body's immune system from attacking itself, the underlying problem in the disease. But they are much more expensive and have been linked with higher risks for potentially fatal infections. Also, the FDA is investigating possible cancer risks.
"My message to patients is that these biological products often can treat very difficult to treat diseases but may have very substantial risks and that you need to take extra care to educate yourself as to what those risks might be," Moore said.  JAMA: http://jama.ama-assn.org

Comments

[PhillyLisa]

Totally agree, Kim! And I'd like to add that even those with high-functioning autism or Asperger's can suffer tremendously with physical symptoms. My daughter, who has a diagnosis of HFA, is not physically well enough to function in a classroom. I have to homeschool her. After two or three hours she shuts down. We still haven't ruled out mitochondrial disorder. Even with a diagnosis of HFA, without recovery I see no hope of her ever being able to function even as well as our Aspergian college student here. Her IQ score isn't going to make a bit of difference in helping her to live independently.

[Stagmom for college student]

Good morning, Aspergian college student. Where do I begin. First off, I'll speak only for myself. I have three children with full blown autism. You need to understand that Age of Autism is a site dedicated to the treatment and/or recovery path for autism. That makes us somewhat self selecting in readership. It's great that you are proud of yourself and comfortable with who you are.

But you need to respect that most of us here have children, young and older, who are profoundly handicapped by what is being called autism.

Thanks for sharing your perspective. I hope your Asperger's doesn't prevent you from seeing our perspective too.

Kim

[Anonymous College Student with an Autistic Disorder]

AUTISM IS NOT ALWAYS A CATASTROPHE!!!
I'm a college student with Asperger's Syndrome, a form of high-functioning Autism. I have lived with, suffered with, and THRIVED WITH this disorder since the moment that I first drew breath in this world. Personally I am astound that people are choosing NOW to freak out about autism. I have a couple of points to make about this: 1. Autistic children vary in intelligence and connection to the world. Some of the greatest geniuses of all time had an autistic disorder. (Albert Einstein, Charles Darwin, etc.) The media has only shown those few unfortunates of us that are SO disconnected from the known world that they cannot function in it. In fact, my autistic disorder is mentioned so rarely that I have to explain what it is to over half of the people I reveal my secret disorder to. So, we've covered the most important aspect of autism, ie. it varies. So, what exactly is constant in autism? Social Deficits. As part of having Aspergers, I struggle on a day to day basis to make friends, maintain relationships, and act appropriately in public. This burden I will carry with me for the rest of my life. However, I want to point out that as a person on the autistic spectrum, I have noticed that there are two sides to autism, one bad, and one good. What could possibly be good about autism, you wonder? Well first of all, consider this: autistic individuals, no matter how severe or slight their symptoms may be, are some of the most unique and interesting people you could ever meet. Sure, we have trouble learning social cues and getting along with other people, but God has given us gifts of extrordinary power. I have heard of a child with autism who had memorized the entire New York City subway system by time he was nine years old, including all the running trains and stops. Granted, not all of us have gifts to that extreme, but we all are given special gifts.
People with high-functioning autism, like aspergers, differ from low-functioning autism in one respect. We tend to have higher intelligence and greater connection to the world.
My belief is that many children with autism and aspergers are misunderstood geniuses that were put on this Earth for a defined purpose, whatever that may be.
It is also not true that all people with full-blown autism never get anywhere in life. Take Temple Grandon, a famous author, public speaker, and animal scientist who has, you guessed it, full-blown autism!!
So... now I get to the bottom line of the reason why I decided to write to the people of this website:

Parents and Researcher of the world dealing with autism,
Is this really an "epidemic" per say. I have lived with autism my entire life and I would never call my disorder an "epidemic." That would imply that it is a problem. I could not live with the thought that I am somehow a lesser form of life that so-called "normal" people. To call autism, a disorder that has been around for generations, an epidemic, is in effect to lower me and all the other autistic children and adults out there to SUB-HUMAN STATUS!!! I have pointed out that autism can provide significant talents. In fact, I would argue that my autism is as much a part of me as the hands that type out these words on the keyboard. So my brain works differently... that's only a problem if I let it be so. My belief is that the majority of children and adults with autism can do wonders with their lives if they don't let society tell them that their useless and handicapped and put all their effort and determination into making it in a world that is hostile to them.

[Cherry Sperlin Misra]

Regarding biologicals, My husband and I once asked our friend, an endocrinologist, if he would take the new inhaled insulin if it came on the market, and he quickly replied- "NO, I would wait for ten years" Surprised, we asked, "Well, what would you do?!" He replied, "I would inject myself with insulin; there is a possibility that the inhaled insulin would cause cancer" Pretty good rule of thumb that- With any new medication, wait for ten years- Let some other , naive people try it first.
And now, for those people who still think that vaccines are always terrific- Take a look at the "rare adverse effects" of the Hepatitis B vaccine. Among so many others, isMultiple Sclerosis! What kind of a deal is that? This is not some idea of mine- I am quoting the manufacturer- They have put it on their insert for Hep B.
Biological products are by their very nature a disaster waiting to happen. Imagine, for example, if one had a mandated vaccine contaminated by mad cow disease. Couldn't happen? Why not? It seems that it probably already has on a smaller scale. Eighty children in the U.K. who died from contaminated hormone product rated only a tiny printed line for one day on CNN. One British health official, when asked how many British citizens might die of mad cow disease , made the glaring mistake of answering truthfully, "Theoretically, everyone" Perhaps my words may sound like scare tactics. They are not meant to be that, but instead a warning of how we must remain true to genuine science.

[Cindy Lozano]

Back in 2000, my sister (age 13 at the time) and I (age 17 at the time) were both put on Prozac for depression. Within the first few months, I started a weird habit where I would cut my arms with knives. I quit the meds a few months later because I felt that I was just getting worse and more self-destructive. I started seeing a therapist (who was such an encouragement to me!) and started eating healthy and started jogging, and suprise, suprise... depression went away! I've had no problems since. My sister was not so lucky. Everytime she got worse, they just kept upping he dose until she wound up in the E.R. getting her stomach pumped for downing a whole bottle of Tylenol. Taking her off the meds was almost as bad. Very similar to Angela's story. She's been off all meds for a few years now and has improved quite a bit. Last year was the first time we ever talked about our Prozac experiences and guess what? Turns out she had started cutting her arms while on Prozac too! Coincidence? Then just a couple years ago the FDA comes out with the warning that Prozac can actually INCREASE thoughts of suicide in teens! And not just that, but in the original trials, they had covered up evidence of that!

[Gatogorra]

Jeanne-- Bennett worked with and owns stock in Sanofi. Does that match the alarm bell that was going off in your head about what he said?

[Gatogorra]

Angela,

Read "Rethinking Psychiatric Drugs" by Grace Jackson, MD. There's an explanation which smacks on what you're describing-- clinical evidence of negative cellular adaptation to a drug. The chapter ripping apart the dopamine theory is good fun too.

I hope your boys are okay now.

When I wrote to the author and mentioned how common mito dysfunction was in autism and sent material on the Hannah Poling case, she wrote back that, in short, that "virtually all" psych drugs induce or worsen mitochondrial dysfunction. She also agreed that if certain drugs (I remember discussing particularly benzos and SSRIs) increase the permeability of the blood-brain barrier, this could theoretically suck for kids with already injured BBBs who also have a body load of toxic metals just waiting to enter the brain. Some SSRIs and benzos are used as co-therapies to chemo for just this reason- they carve gaps in the BBB, making the brain more accessible to chemotherapy drugs.

[anonymous antivaccinationist]

Jack said: [Vaccines are regulated as Biologicals by the FDA and fall under the CBER, Center for Biologicals Evaluation and Research, division of the FDA as opposed to CDER, which oversees drugs.]

Vaccine makers are permitted to apply for waivers at every turn (including animals involved in manufacture, adverse event reporting, safety standards, lot samples etc...). An EXTREME lack of Regulatory Oversight.

AA

[Jack]

Vaccines are regulated as Biologicals by the FDA and fall under the CBER, Center for Biologicals Evaluation and Research, division of the FDA as opposed to CDER, which oversees drugs.

[Pamela]

Back in June I met with one of my Senators to discuss vaccine safety. In the course of our conversation he mentioned that he has worked on a committee to review and promote standards used for pharmaceuticals containing biologic agents.

He said that there is a lot of concern surrounding how you standardize biologic components in medications to insure that the products are safe and consistent.

I asked him he felt the use of human diploid cells and live viruses in vaccines would fall into their consideration and he said yes. http://www.immunizationinfo.org/vaccine_components_detail.cfv?id=32

Unfortunately, I did not feel knowledgeable enough on the topic to delve much deeper with him. I think this is an area our community should explore as I have always felt the problems with our vaccine program are much broader than the thimerosal issue.

[Angela Warner]

This infuriates me! It has for a long time. From mid 2006 to early 2007, we had both boys on Abilify for different reasons - they took very different doses as well, both very low. In the spring of 2007 we were preparing to enroll Nathan in a randomized double blind placebo controlled study for zeolite. Dave and I had made a pact that we would keep them on the meds for no more than a year. We used this time to do more research and come up with other solutions. Well, with the impending study, we especially wanted to get Nathan back to a baseline before starting so we took them both off (weaned over at least 3 weeks - even considering the low dose). OMG!!! The behaviors that then emerged were far worse than when they originally went on. So of course off I went to do my research on why this was.

I had even long time pharmacists baffled and they told me straight up that they could not answer my questions. I was far ahead of them. I have not had this totally confirmed, and it's been a year and a half since I figured this out, but I will explain to you the basics I found as I remember them.

Essentially the reason their behavior worseded is because while on the Abilify, their systems somewhat adjusted to the med. Then the Abilify basically caused their brains to grow more of the neurons - transmitters (this is where I can't exactly remember which) - and so when they came off the meds totally they had all these extras floating around that were never targeted by the meds. Take away the meds totally and wa la! You can imagine my anger that this was not explained to us at the time they went on the meds. The doc probably didn't even know! I'm a smart cookie, and it took even me several days of putting it all together.

To top it all off, I am now seeing commercials for Abilify on TV for Bi-Polar. The ad says hundreds of thousands have taken Abilify. I wonder how many people actually take comfort in that and run to their doc???

Then on Tuesday night right before bed I got an email and now Abilify has TWO black box warnings! TWO!!! It had nonw when the boys were on it!

As I said... Infuriating!

Oh yeh... Sargent Goodchild, you are 100% right. I think if that language was used - meaning effects - unintended effects - what impact that would have. Side effects makes them sound acceptable and benign instead of what they actually are... unintended effects that range from irritating to possible death.

[Sargent Goodchild]

There is no such thing as "side effects" only effects. Some effects are desired and intended others are unintended and unwanted. Imagine if the ad said “unwanted effects include…” The word "side effects" obfuscates the massive problems associated with medications as well as living in a phramacracy.

[Jeanne]

But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm. "If most issues are discovered within the first few years, then the system is working," Giezen said. Bennett says it's unreasonable to think that the studied drugs' safety issues should have been discovered before they were marketed. That's because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.

Are you f^*#ing kidding me? Seriously. I have so many issues with this. I must stop and think and then come back and comment.

[Tanners Dad]

Prescription Drugs, Products Liability, and Preemption of Tort Litigation
Catherine D. DeAngelis, MD, MPH; Phil B. Fontanarosa, MD, MBA
JAMA. 2008;300(16):1939-1941.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The benefits and risks associated with pharmaceutical agents and medical devices have received increasing attention from the medical community, the public, and government agencies. Serious concerns about US Food and Drug Administration (FDA) capabilities and oversight for ensuring accurate determination of safety and efficacy, appropriate mechanisms and decisions regarding drug and device approval, and effective postmarketing surveillance have prompted investigations by the Institute of Medicine1 and by an FDA blue ribbon commission.2 Major legislation3 has been enacted to improve the agency's ability to fulfill the daunting responsibility of ensuring that pharmaceutical products and medical devices approved for marketing are safe.4

Even though the evaluation of new drugs and devices is technically rigorous, the current approach of basing drug approval decisions on clinical trials of efficacy that include relatively small numbers of patients virtually guarantees that the full risks and complete . . . [Full Text of this Article]

Author Affiliations: Dr DeAngelis is Editor in Chief and Dr Fontanarosa (phil.fontanarosa@jama-archives.org) is Executive Deputy Editor, JAMA.
http://jama.ama-assn.org/cgi/content/extract/300/16/1939

This is a related foundational article teaser to the one above. What do you think the next line is after...

that include relatively small numbers of patients virtually guarantees that the full risks and complete . . .

My feeling is...
...are never fully disclosed???
We do not have to write the headlines the mainstream medical community is so arrogant that they think we do not read. I was amazed by the article yesterday that said only 42% of the medical community get flu shots yet they want to mandate it for babies...
http://www.ama-assn.org/amednews/2008/10/27/edsa1027.htm
http://www.causecast.org/member/tanners-dad

[Tanners Dad]

Dr. Charles Bennett, a Northwestern University drug safety expert. said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

That is an amazing quote. Is that directly contributed to Bennett. Should it have quotation marks? I would love to use it around the web.
http://www.causecast.org/member/tanners-dad