Patient Taking Adalimumab (Humira) - Questioning Why Makers of The Drug Are Preventing Disclosure of Trial Data.

......He isn't the only one wondering what in the hell is up AbbVie's sleeve.  

I don't even take the drug, I never will, but what's the deal with withholding data like this.  Let's see it, AbbVie!  Shouldn't trial information be available to the general public in order for people to make informed decisions regarding the best treatment choice? How can people do that, when the information isn't there!?  
I visualize a bunch of robots.. The robots are the patients, they take what they are given and do as they are told.  God forbid people ask questions and want the answers and demand them.  People have the right to know this information... right?  For the people that take this stuff, they put the chemical into their body everyday and they aren't allowed to know everything there is to know about the stuff?  That just doesn't sit well with me and it shouldn't sit well with you either.  
It's sketchy.. The whole drug/medicine/medical industry can't be trusted.  They really are starting to show their faces by trying to put a curtain in front of them.  When people are told "No" to something that is usually otherwise available, it just holds a red flag to it and makes people wonder things, speculate what the reasons may be for withholding.  AbbVie is making it quite clear that they have something to hide.  Logically, what reason would they have for wanting to hold back trial data... unless the data shows something that could result in an unfavorable response.  It might make people requestion if Humira is for them or not.  Now if the data were positive, wouldn't the company want to display it for the world to see?  It would lead to more sales and continued use of the treatment.
Let's face it, your doctor isn't running down the whole list of possibly negative consequences of taking the drug before you start it.  He/she just isn't and that's that. They shine a positive outlook on the drug because they want you to take it.  In addition, THEY don't even know the ins and outs of the drug.  That's really our job and our responsibility as patients to do our homework.  Some people do their research and some  people don't, but for the ones who do, not having this information easily available or just not showing "all" of the information is just giving people a false/skewed view of what the drug really is.  
Not cool!

A patient with Crohn's disease is concerned about the attempt by the makers of adalimumab to prevent disclosure of trial data submitted during the drug's approval process, according to a personal view piece published online April 16 in BMJ.

THURSDAY, April 18 (HealthDay News) -- A patient with Crohn's disease is concerned about the attempt by the makers of adalimumab to prevent disclosure of trial data submitted during the drug's approval process, according to a personal view piece published online April 16 in BMJ.

Alex Lomas, a patient with Crohn's disease from London who has been taking adalimumab for three years with beneficial results discusses the lack of trial data available on biologicals.

Noting that part of the National Institute for Health and Care Excellence's approval for use of adalimumab for Crohn's disease was the recommendation to set up a registry to track long-term outcomes and relapse rates after treatment withdrawal, Lomas reports that registries are fragmented or are still at pilot stage. He adds that the attempt by AbbVie, the maker of adalimumab, to prevent the European Medicines Agency from disclosing recent trial data submitted during the drug's approval process is cause for concern and is preventing patients and health care providers from making informed decisions about the use of this treatment.

"As the drug industry and medical profession as a whole move towards the registration of all trials, and the publication of all trial data -- in no small way thanks to the All Trials initiative (www.alltrials.net) -- this decision by AbbVie is a backwards step and is offensive to trial participants, patients, and the wider public who ultimately pick up the tab," Lomas writes.

Health News Copyright © 2013 HealthDay. All rights reserved.

The patient Alex Lomas is taking a biological drug for Crohn’s disease, and he wants to know why the maker is trying to prevent disclosure of trial data that may well affect him

I have an obsession with data. I have instruments in my house so I know how hot each room is and to warn me if the fridge door has been open for too long. I record my weight and blood pressure using devices connected to the internet so that I can monitor long term trends. I use my smartphone to track how much walking and exercise I do.

I was diagnosed with Crohn’s disease about 20 years ago, when awareness of inflammatory bowel diseases was not as high as it is today.1 The treatment decisions made at the time of my diagnosis had unfortunate side effects for me as a teenager. High doses of prednisolone led to Cushing’s syndrome, and I was mercilessly teased about my appearance at school. With time came a reduction in the dose of steroids required, but I had to take them throughout my 20s, and control of my symptoms was still inadequate.

As a patient with Crohn’s disease, I take an active interest in my day-to-day health, but I also routinely scan news media and journal sites for new treatments and for changes to current best practice in the management of my condition. I often arrive at appointments with my consultant armed with PDFs printed from the BMJ, the Cochrane Collaboration, and the National Institute for Health and Care Excellence (NICE) to discuss the latest trials and treatment options. Yes, I’m afraid I’m one of those patients.

Three years ago my consultant suggested a new course of treatment with adalimumab (Humira), an anti-TNFα monoclonal antibody. My local primary care trust approved this new drug, which costs £352 per injection, and which I administer myself by injection each fortnight.2 Since I started taking adalimumab I have the least symptoms since diagnosis. I am no longer taking steroids; I have started to recover from 15 years of side effects; and I spend less time in clinical care and off work on sick leave.

However, anecdotes are not the foundation of evidence based medicine, and nor are they a rational basis for evaluating the cost of a treatment. On 1 April 2013 responsibility for commissioning transferred from my primary care trust to the local clinical commissioning group, bringing into sharp focus the question of whether the NHS is getting value for money in continuing my treatment.

Equally importantly, I want to be able to evaluate the benefits and risks of these costly pharmaceuticals with which I inject myself regularly. Biologicals are relatively new, and have failed spectacularly in clinical trials.3 Who knows what 20 or 30 years of data from clinical use might bring? The most recent Cochrane review of biologicals looked at nine studies, and, although it found that they were effective, it noted that none of the trials allowed for an assessment of long term adverse events nor had any trials been undertaken that compared efficacy among the available biologicals.4 My consultant recently told me that no trials had been done to determine what the minimum effective dose of adalimumab was, nor would there likely ever be; a drug company has no interest in showing you can take less of something.

Part of NICE’s approval for the use of adalimumab in treating Crohn’s disease was the recommendation that a register of patients being treated with biologicals be set up to track long term outcomes and relapse rates after withdrawal of treatment, something patient groups welcomed.5 Unfortunately it seems that such registers are fragmented, with registers of patients with rheumatoid arthritis held independently from registers of patients with inflammatory bowel disease, or are still at pilot stage.6

As a patient, I need clinicians to interpret trial data and systematic reviews of new and existing treatments so we can come to appropriate decisions about my treatment, but what if even experts don’t get to see the whole picture? How can we even know what trials are being run?

I was therefore dismayed to learn that Abbvie, the maker of adalimumab, are seeking a legal injunction to prevent the European Medicines Agency from disclosing trial data submitted during the drug’s approval process.7 With such a new drug, it is vital that all data, whether it’s good news or bad, are made available so that I, my consultant, and the care commissioning group can make informed decisions about the efficacy and cost effectiveness of treatments.

As the drug industry and medical profession as a whole move towards the registration of all trials, and the publication of all trial data—in no small way thanks to the All Trials initiative (www.alltrials.net)—this decision by Abbvie is a backwards step and is offensive to trial participants, patients, and the wider public who ultimately pick up the tab.

Notes

Cite this as: BMJ 2013;346:f2336

Footnotes

• Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
• Provenance and peer review: Not commissioned; not externally peer reviewed.

References

1. ↵
   Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time. Gastroenterology2012;142:46-54.

   CrossRefMedlineWeb of Science
2. ↵
   Adalimumab. British National Formulary. www.medicinescomplete.com/mc/bnf/current/PHP6632-humira.htm.
3. ↵
   Goodyear M. Learning from the TGN1412 trial. BMJ2006;0:38797.635012.47
4. ↵
   Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn’s disease. Cochrane Database Syst Rev2008;1:CD006893.

   Medline
5. ↵
   NACC. A good decision from NICE on antiTNF treatments for Crohn’s disease. 2010. www.nacc.org.uk/downloads/media/NACC_statement_antiTNFs_4_March_2010.pdf.
6. ↵
   Alrubaiy L, Williams J, Morgan J. P422. The Biologics Register for inflammatory bowel disease in the UK: setting the clinical dataset and the IT infrastructure. ECCO, 2013. https://www.ecco-ibd.eu/publications/congress-abstract-s/item/p422-the-bi.html.
7. ↵
   Kmietowicz Z. Drug firms take legal steps to prevent European regulator releasing data. BMJ2013;346:f1636.

   FREE Full Text

I’m a patient: show me the trial data | BMJ:

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#UC/Ulcerative Colitis Drug Market (Pharms Producing-TNF alpha inhib, CAM inhibitors)-Expected 2 Dbl Over Next Decade - $3.7B

lol I think i'm going to buy stock in Simponi... why the heck not.
There's almost no risk in this area of the market because it's going to make money.  No question about it.  They market the shit like it's going to be gone tomorrow.  Pharmaceutical companies makes $, but the TNF-alpha inhibitor pharms that produce this kind of drug BANK so much money. It's almost in conceivable.

Why not reap the benefits of this shit??  It's almost stupid not to.   That's my view when I see the stats & dollar amount.  The sales amounts have always just increased.

Keep kickem back!  Please do.  It's so obvious and makes sense that they are. It gives me a much better understanding when i'm sitting in the exam room with my doctor and processing everything he is saying to me.... & why.
__________________________________________________________________________________________

The Ulcerative Colitis Drug Market Will Double Over the Next Decade, Increasing to $3.7 Billion in 2021

Primary Factors that Will Drive Market Growth are the Uptake of Humira, Simponi, Vedolizumab and Tofacitinib, According to Findings from ArticlDecision Resources

December 19, 2012-Burlington, Mass. –Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the ulcerative colitis drug market will double over the next decade, increasing to $3.7 billion in 2021 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. The uptake of two premium-priced tumor necrosis factor-alpha (TNF-alpha) inhibitors—Abbott/Eisai’s Humira and Janssen/Merck/Mitsubishi Tanabe’s Simponi—and two novel therapies, Takeda’s cell adhesion molecule (CAM) inhibitor vedolizumab and Pfizer’s oral Janus-activated kinase inhibitor tofacitinib, will primarily drive growth during this period, as will the expanding number of diagnosed prevalent cases of ulcerative colitis.

The upcoming Pharmacor advisory service entitled Ulcerative Colitis, which will be published soon, forecasts that increased physician acceptance of TNF-alpha inhibitors for the treatment of moderate to severe disease and patient preference for convenient subcutaneous administration will fuel the uptake of newer TNF-alpha inhibitors Humira and Simponi through the 2021 study period. Simponi, owing to its perceived greater efficacy than that of Humira in separate Phase III trials and favorable gastroenterologist opinion, will challenge intravenous infliximab’s (Janssen/Merck/Mitsubishi Tanabe’s Remicade) standing as the most frequently prescribed agent in the TNF-alpha inhibitor class. However, Remicade will remain the patient-share leader among the TNF-alpha inhibitors, maintaining a relatively constant patient share across the G7 countries, based on its well-established efficacy. Sales of Simponi are expected to overtake Remicade’s sales in 2017 based largely on the former’s premium price and assumed high dosing in ulcerative colitis, driving the market’s growth as the new sales leader.

The launches of two promising premium-priced novel agents, vedolizumab and tofacitinib, in 2014 and starting in 2016 respectively, will contribute to increasing sales over the ten-year forecast period, gaining most initial use in the TNF-refractory population.

“These agents will likely extend the treatment algorithm by offering, for the first time, additional lines of therapy for patients with inadequate response to the TNF-alpha inhibitors,” said Decision Resources Analyst Kathrina Quinn, Ph.D. “Although the TNF-refractory market is relatively limited in size, the high unmet need for treatments that cater to this population and potentially delay or prevent colectomy will drive major-market sales of approximately $740 million in 2021, constituting about 20 percent total market share.”

Towards the end of the forecast period, Decision Resources anticipates that vedolizumab and tofacitinib will begin to overtake adalimumab’s use as gastroenterologists move to another drug class after trying up to two TNF-alpha inhibitors. Even though vedolizumab is expected to launch first, tofacitinib’s uptake will likely overtake that of vedolizumab’s based on the strengths of its oral delivery and postmarketing safety data for other immune indications.

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group atwww.DecisionResourcesGroup.com.

###

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact:

Christopher Comfort
Decision Resources Group
781-993-2597
ccomfort@dresources.com

Ulcerative Colitis Drug Market Will Double Over the Next Decade - Decision Resources:

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Study Conducted To Examine Safety of ‘Biologic’ Meds - Rheumatoid Arthritis Patients

The study was published August 8, 2012 in the journal  -> Arthritis & Rheumatism.  The study looked at the 3 most popular TNF-alpha inhibitors used in the United States and in other countries to treat rheumatoid arthritis, and death rates among people treated by them.  
Even although the subjects of the study were RA patients, try looking at the disease factor with a grain of salt.  In my opinion, the more important factor is the overall safety of the Biologic medications (despite what the condition is).  Would the death rates be much different if the subjects of the study were Crohn's disease patients?  Possibly, but my guess would be that the numbers would be around the same.  So, read the article placing significance on the drug, not the disease.

 Article Highlights

"The study was published Aug. 8 in the journal Arthritis & Rheumatism.

The three drugs studied include Humira, Enbrel and Remicade, all from a relatively new class of medications called TNF-alpha inhibitors." 

"...understanding risk versus benefits of treatment with the most commonly prescribed biologics is important for physicians and patients in managing rheumatoid arthritis," study lead author Dr. Julia Fridman Simard, of the Clinical Epidemiology Unit at the Karolinska Institute, in Stockholm, said in a journal news release."

"In the new study, Simard's team compiled information on patients with rheumatoid arthritis who began treatment between 2003 and 2008. Of these patients, more than 1,600 started taking adalimumab (Humira), almost 2,700 were prescribed etanercept (Enbrel), and more than 2,000 began treatment with infliximab (Remicade)."

"During the five-year study, 211 of the patients died. However, the researchers found no difference in death rates among the three drugs."  - The Doctors Lounge

Study Compares Safety of ‘Biologic’ Meds for Rheumatoid Arthritis --Doctors Lounge:

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Patient Diagnosed w/ Cancer After Humira Treatment - Abbott Labs Lawsuit for Many Claims

Entire Article Below :)    

Reading articles like this one doesn't shock me.  I know everything about these drugs and it's only a matter of time before we start seeing similar sad effects from these horrible toxic drugs.  Watch....  you will see this happen for yourself as time goes on.  

The effects of the drug are available if you search, and I always take time to read about the drug I plan to be putting in my body.  NEVER trust your doctors word... even if he is the greatest doctor.  You have no idea if your doctor is recommending Humira  (or any other drug for that matter) because they are getting "kick backs" - it's discussed in the article below,  a short definition of the meaning - a KICKBACK is a payment made to someone who has facilitated a transaction or appointment, esp. illicitly.  Illegal Yes, paying physicians money to recommend a drug so sales will increase, is not the correct reason to suggest a treatment.  That's why It's so important to do your homework before saying "yes" to a treatment.  It doesn't matter how many positives your doctor tells  you about and that he told you it is a SAFE option .  

I CANNOT STRESS THIS ENOUGH - Do yourself a huge favor, find out the facts for yourself.

This is how---->  Read non biased information (a biased source -  the pharmaceutical company's website about the drug.  Of course they will shed light on mostly the benefits).  Read information from a reputable source (a peer review journal article, Pubmed (where you can find published research results.  Looking up specific keywords of your choice - Pubmed is linked on my side bar for easy access.).  
Once you've gathered and read through enough information , next weight the positives of taking the medication and the negatives (risks). Are the possible dangers worth it for the condition you have, is there a safer option available,  Have you tried all other treatments for your condition and seem to be hitting a wall in regards to medications thatwill bring you relief. What natural therapies are available to treat the condition, who would be a good candidate to take a medication with dangerous side--effects like Humira (your genetics matter)

Arthritis Drug Humira Blamed for Cancer

By JACK BOUBOUSHIAN 

 CHICAGO (CN) - Abbott Laboratories' blockbuster arthritis drug Humira gave a woman cancer, she claims in Cook County Court.
     Carolyn and Eric Shaw sued Abbott Laboratories for product liability, product defects, failure to warn, misrepresentation, negligence, breach of warranty and loss of consortium.
     "Plaintiff Carolyn Shaw was prescribed Abbott's blockbuster arthritis drug 'Humira' and received bi-monthly injections from October 2008 to August 2010 when she was diagnosed with B-cell non-Hodgkin's follicular lymphoma. She underwent surgery and chemotherapy treatment, and luckily her cancer went into remission. Unfortunately, she will have to undergo treatments every five months for the rest of her life to ensure the cancer will not return," the complaint states.
     The FDA approved Humira to treat arthritis in December 2002. It is Abbott's best-selling drug, according to the complaint.
     "(I)n 2011, Humira's worldwide sales were $7.9 billion," the Shaws say.
     The complaint states: "the data from Humira clinical trials and other peer-reviewed medical literature show that the rate of malignancies in the group of patients treated with Humira was significantly higher than the rate of malignancies in the group that were treated with placebo. The increased rate of lymphomas was statistically significant. This differential in rate was a significant safety signal. It should have prompted a significant clear warning from Abbott to both physicians and patients about this potential side effect.
     "Although the clinical trial data alone should have prompted both a stringent warning and proactive study, instead of conducting further studies and/or otherwise calling attention to the increased risk of life-threatening side effects front and center in the label, and communicating same to Dr. Suarez [Carolyn Shaw's nonparty rheumatologist] Abbott buried and information regarding malignancies in the label. Further, what 'warning' information was mentioned severely downplayed the risk and confused the issue, consistent with its sales message, in RA [rheumatoid arthritis] data."
     The complaint adds: "It is widely recognized within the pharmaceutical industry that adverse side effects of medication are vastly unreported. The industry accepted rule of thumb is that the MedWatch system captures somewhere between 1 percent and 10 percent of real world events. Therefore, the MedWatch reports put Abbott on notice that, in fact, there were somewhere between 250 and 2,500 real world Humira patients who had experienced Humira-related lymphomas or other malignancies.
     "Because FDA regulations require the drug manufacturer to add a warning - in the warnings section of the label - whenever there is a 'reasonable association' between the drug and a dangerous side effect, and further state that 'a causal relationship need not be established' before a warning is required, this information from the adverse event database should have prompted Abbott to issue strong, clear warnings about the risk of lymphomas and other forms of malignancies due to the use of Humira. But Abbott failed to do so until many years later, when the FDA made them do it."
     The Shaws say: "Not until August 4, 2009 - almost a year after Carolyn Shaw began taking Humira - did Abbott put a black box warning on their label alerting patients and doctors of cases of leukemia, hematological cancer, in adults, adolescents, and children."
     Carolyn Shaw developed an enlarged lymph node in her neck in 2010 and was diagnosed with Stage IIA lymphoma. "When Carolyn and Wayne asked Dr. [Mark] Freidman what he thought caused her lymphoma, his answer was 'Humira,'" the complaint states.
     The Shaws claim that Abbott aggressively markets Humira and makes "widespread use of direct payments to physicians utilized by Abbott to both sell more Humira and increase prescriptions across the country."
     "Needless to say, these financial inducements and payments provide incentives, perhaps on a subconscious level but real nonetheless, to skew the 'informed consent' discussion in favor of the benefits of Humira, at the expense of the risks. More importantly, patents are not aware of these types of 'behind the scenes' payments being made to physicians. ... It most certainly was not disclosed by either Abbott or the prescribing physicians to the individual plaintiff and/or patient."
     Abbott Laboratories is the only defendant. Neither of the Shaws' doctors is a party to the case.
     The Shaws claim that Abbott withheld critical information that would have enabled Carolyn to make an informed decision about whether to take Humira: "Although physicians prescribe medications, it is patients who have the ultimate authority to decide whether to put them into their bodies or not. Because of the dangerous side effects of Humira, it is extremely important that both physicians and patients be fully informed - not only about the potential benefits of the drug, but also about the risks of side effects. Neither Carolyn nor her physicians were warned in any meaningful or legally adequate manner about the risk of lymphoma when she began taking Humira," the Shaws claim.
     The Shaws are represented by Gary McCallister.


Courthouse News Service:

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The Epoch Times Highlights 7 Diseases That Will Increase Drug Companies Profits - They Hope & Pray That You Have At Least 1 Of Them.

This article covers several different conditions and health problems from depression, to arthritis that are big money makers for the drug industry.  Conditions that can be easily categorized into a "treatable" (meaning you will be prescribed expensive medication to manage your condition) diagnosis which then allows the $$$ to come pouring in!
I have included some highlights from 1 of 3 and 2 of 3 and include the link below each highlight.  Next week I will post the 3rd and last article.
(This posting is not focused directly on Crohn's Disease and digestive diseases, however the the medications they discuss are used for some patients with Crohns, UC ect.  Also, more times than not, people have a dual diagnosis or more than 2 and are taking medication to treat the condition.  Due to the fact that these articles discuss several conditions and medications, I thought it would be worth posting to educate and expand awareness.
I like to draw attention to articles that touch on the motivations of the big pharmaceutical companies and the FDA.  When it comes to health care in the US, the system is highly flawed.  I've figured that out by reading and researching Crohn's Disease and it has lead me to read some very eye opening articles (yes they are reputable). I'm not frowning upon all drug companies and medications, I just want to inform people to be cautious and not so trusting of our medical system.  Being skeptical is being smart.

HIGHLIGHTS I COULDN'T RESIST POSTING _

"Supply-driven marketing, also known as “have drug, need disease and patients,” not only turns the nation into pill-popping hypochondriacs, it distracts from pharma’s drought of real drugs for real medical problems.

Of course not all diseases are Wall Street pleasers. To be a true blockbuster disease, a condition must meet certain criteria" 

read more............
seven-diseases-big-pharma-hopes-you-get-in-2012 1OF3

"In 2008, the FDA announced that 45 people on Humira, Enbrel, Remicade, and Cimzia died from fungal diseases. The FDA also investigated Humira’s links to lymphoma, leukemia, and melanoma in children.

This year, the FDA warned that the drugs can cause “a rare cancer of white blood cells” in young people, and the Journal of the American Medical Association (JAMA) warned of “potentially fatal Legionella and Listeria infections” from the use of these drugs."

read more............
seven-diseases-big-pharma-hopes-you-get-in-2012 2OF3

Generic Biological Drugs Coming-Awww, what a drag for Abbott, J&J, Amgen Inc.

Biological Drugs = The most costly drugs in the world.... Here's some good news though

Healthcare law to allow generic versions of biotech drugs

The development of 'biogenerics' is expected to put the brakes on the profit bonanza from such drugs as Abbott Laboratories' Humira.

By Bruce Japsen

June 2, 2011

In 2001, Abbott Laboratories spent nearly $7 billion on the biggest acquisition in the company's 123-year history, primarily to get access to one drug: Humira.

Since then, the North Chicago drug giant has raked in more than $24 billion in sales from Humira, a pricey medicine derived from human cells and used to treat a variety of autoimmune diseases. This year, Humira is forecast to have its biggest year ever, with some analysts projecting more than $7 billion in sales.

But the national healthcare law is intended to put the brakes on the profit bonanza from Humira, as well as many other biotechnology drugs, by opening up the sector to generic competition. That will make biotech drugs — also known as biologics, which are innovative treatments derived from living cells — affordable to more consumers.

Many patents on some top-selling biotech drugs will start to expire in the next few years. But when "biosimilars" or "biogenerics" will be available to U.S. consumers is unclear. The Food and Drug Administration is working on guidance on how the approval for this class of generic drugs will work.

"Biotech drugs are among the world's most expensive," said Sidney Wolfe, director of the health research group at Public Citizen, a consumer watchdog of the healthcare industry. "They have been good, but they have been expensive, so it is extraordinarily important to get biogenerics as quickly as possible."

The Affordable Care Act, signed into law by President Obama in March 2010, clears a path for the FDA to approve generic forms of biotech drugs. Biogenerics have been unavailable in the U.S. because they were not part of the 1984 landmark Hatch-Waxman Act, which allowed for cheaper generic versions of chemically derived drugs.

Thanks to the 1984 law, consumers have access to generic versions of many blockbuster treatments, including the cholesterol drug Zocor and the antidepressant Prozac, which can cost $3 to $5 a day. The generic forms of those drugs typically cost pennies a day.

But biotech drugs weren't developed until the 1980s, when technology cleared the way for geneticengineering on DNA, allowing drug companies to rake in huge profits from this relatively new class of treatments.

Humira is a monoclonal antibody, hailed for its ability to work like a smart bomb because of its ability to precisely attack disease cells. Abbott says more than 500,000 people worldwide are taking Humira to battle a variety of autoimmune diseases, including rheumatoid arthritis, Crohn's disease and psoriasis, often halting progression of the condition.

But the innovation has come with a price. Humira costs patients, their employers and health insurance companies about $20,000 for one year of treatment. Doctors say costs can run higher depending on the patient and dosage needed.

The anti-anemia drug Epogen can cost more than $10,000 a year per patient, and biologic medicines for cancer and other life-threatening diseases can cost tens of thousands, sometimes more than $100,000 a year.

Although biotech drugs are very expensive for consumers, they can pay off for drug companies.

When Abbott engineered its $6.9-billion acquisition of Knoll Pharmaceuticals, which developed Humira, Wall Street analysts and investors thought the company spent too much. The drug industry at the time often touted the cost of researching and developing one drug at $800 million or more.

Knoll provided Abbott with a host of products, including the popular thyroid treatment Synthroid and the diet drug Meridia, which had a few years of good sales before the FDA requested that the company take it off the market because of heart risks. When Abbott bought Knoll in 2001, which was before Humira won FDA approval, Knoll was generating about $2 billion in sales.

"They have more than recouped their investment," Wolfe said of Abbott.

Miles White, Abbott's chairman and chief executive, recently indicated that Humira would continue to be a blockbuster, given that its first patents don't expire for another five years.

"Humira has been a phenomenally successful product with application in a lot of different disease categories," White said at the company's annual shareholder meeting. "Humira's got long legs, out until about at least 2016, when its first patents begin to expire."

White is banking on all of the FDA-approved indications for Humira, which has held up against competition from rival rheumatoid arthritis and Crohn's treatments derived from biotechnology, such as Johnson & Johnson's Remicade and Amgen Inc.'s Enbrel. The patent for Remicade also is expected to expire in the next few years.

"It is yet unclear what kind of competition we'll experience from biosimilars or the equivalent of generics at some point later in time," White said. "So I think some of the concern about Humira is exaggerated and overblown."

One primary obstacle that could delay entry of a Humira rival lies with the FDA. The agency said it was continuing to work on the regulatory review process, which will require clinical trials, unlike the process used to approve generic copies derived from chemicals.

Neither Abbott nor the FDA is aware of a company that has begun to work on a biosimilar version of Humira, but some companies are starting clinical trials of biosimilars of other drugs. Lake Forest, Ill.-based Hospira Inc., for example, is selling a biogeneric of Epogen in Europe and last year began clinical trials in 20 U.S. hemodialysis centers.

Some analysts think it will be difficult for companies to replicate biologics as easily as pills and capsules derived from chemicals. Biologics are more complex to make, and there are not enough makers to drive prices down to the 60% to 80% discounts that are common among chemically derived pills and capsules, some analysts say.

"When Humira loses patent protection in 2016, it may become an albatross similar to Pfizer's Lipitor,"Morningstar Inc. analyst Damien Conover said in a recent report, referring to the generic competition that Pfizer's cholesterol pill faces in November. "However, since we believe the drug's biologic composition will dilute the impact of generic competition, we project an immediate sales decline of 20% following the patent loss, instead of the typical 80% crash."

Abbott Labs -Just read 1st quarter global sales amount w/ Humira & almost puked!

Abbott's Humira is currently approved, either as a single therapy or in a combination, to treat rheumatoid and psoriatic arthritis in adults, and a type of juvenile arthritis affecting children. The drug is also approved to treat adults suffering from Crohn's disease, as well as severe chronic plaque psoriasis. Humira is a money spinner for Abbott, with first-quarter global sales improving 17.8 percent to $1.65 billion. Of this, U.S. sales grew 16.2 percent to $630 million.


In another article from RTTNews, Abbott Labs is working on getting Humira approved for Ulcerative Colitis, or UC for short.  The % of people that went into remission isn't very impressive.  It's significant, but barely.


According to the company, of the 248 patients treated with HUMIRA in the study, 16.5 percent achieved clinical remission compared to 9.3 percent on placebo at week 8. At week 52, 17.3 percent achieved clinical remission compared to 8.5 percent on placebo. These results were statistically significant compared to placebo.
HUMIRA is not approved for the treatment of UC. Abbott recently submitted applications to both the U.S. Food and Drug Administration and the European Medicines Agency seeking approval to market HUMIRA for the treatment of moderate to severe UC.

FDA finds more blood cancer with TNF blocker drugs *Reuters Article*

FDA finds more blood cancer with TNF blocker drugs

WASHINGTON | Thu Apr 14, 2011 4:15pm EDT

(Reuters) - U.S. health regulators have received more reports of rare blood cancer in young patients taking a class of anti-inflammatory drugs used to treat digestive disorders.

The drugs, called tumor necrosis factor (TNF) blockers, are used to treat Crohn's disease and ulcerative colitis that cause inflammation of the digestive system.

They include such widely used products as Merck & Co Inc's and Johnson & Johnson's Remicade and Simponi, Amgen Inc's Enbrel, Abbott Laboratories Inc's Humira and UCB SA's Cimzia.

The Food and Drug Administration has previously warned of an increased risk of lymphomas and other cancers associated with the use of TNF blockers in children and adolescents.

In its communication on Thursday, the FDA said the blood cancer, known as Hepatosplenic T-Cell Lymphoma or HSTCL, was reported primarily in adolescents and young adults who were taking TNF blockers, as well as other drugs such as azathioprine that also suppress the immune system and mercaptopurine, a leukemia drug.

The product labels for Remicade and Humira have been updated and the product labels for azathioprine and mercaptopurine were being updated to include warnings about HSTCL, the FDA said on its website.

The majority of the cases reported were in patients being treated for Crohn's disease or ulcerative colitis, the FDA said, but the reports also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis.

TNF blockers suppress the immune system by blocking the activity of TNF (tumor necrosis factor), a substance in the body that can cause inflammation and lead to immune-system diseases.

Yuck = Biologic Drugs-Article states Humira causes permanent nerve damage

Abbott Labs Sued on Claim Humira Caused Lasting Nerve Damage

Abbott Laboratories (ABT) was sued on claims that its top-selling drug Humira caused permanent nerve damage in the feet of a Montana woman who took it for Crohn’s disease.

Two doctors who treated Kara Mae Pletan at the Mayo Clinic in 2008 said the nerve damage in her feet “was most likely due to Humira,” according to the lawsuit, which was filed today in state court in Chicago, near the company’s headquarters in Abbott Park, Illinois.

The complaint also alleges Abbott knew that Humira, which had 2010 worldwide sales of $6.5 billion, could cause peripheral neuropathy before it began marketing the drug to Crohn’s patients in 2007. Earlier this year, Abbott was sued by two arthritis sufferers in Texas andMassachusetts who claim Humira gave them cancer.

“Abbott has downplayed the risk of side effects, including the very real risk of permanent neuropathy,” Andy Vickery, Pletan’s lawyer, said in an e-mail.

Abbott initially sold Humira in 2003 as a treatment for rheumatoid arthritis. The U.S. Food and Drug Administration now approves Humira for the treatment of five additional autoimmune diseases, including Crohn’s.

Humira is expected to outsell Roche Holding AG (ROG)’s Avastin cancer medicine by 2016 to become the world’s most lucrative drug, according to a May 2010 forecast by research company EvaluatePharma.

Safety Data

“Humira has more than 12 years of clinical and safety data and best-in-class efficacy,” Adelle Infante, an Abbott spokeswoman, said in January, after the filing of the first lawsuit claiming Humira caused a Texas woman’s cancer. “The therapeutic risks associated with Humira are well known and documented in the prescribing label.”

Infante today declined to comment on the nerve-damage suit because Abbott hasn’t read the complaint.

Humira’s full package insert as of July 2004 warned that patients in clinical trials of similar types of drugs had developed more cancers than patients receiving other rheumatoid arthritis treatments. The class of drugs, known as tumor necrosis factor-blockers, prevent the body’s cancer-killing cells from working.

“The FDA has yet to focus in on the risk of neuropathy and other forms of neurological side effects, and Abbott has chosen to provide little if any information about these risks to either physicians or patients,” Pletan said in the complaint.

Issued Report

Doctors at Angers University in France issued a report in April 2006 suggesting that Humira could cause peripheral neuropathy, Pletan said in court papers.

“Abbott was actually aware of this article prior to the 2007 launch for Crohn’s,” she said.

In January, Gayathri Murthy, a Houston hospital worker, sued Abbott claiming she developed lymphoma while taking Humira for arthritis in 2005 and 2006. Earlier this month, a Massachusetts arthritis patient, Maureen Calisi, sued the company for allegedly causing her lymphoma after she took Humira from 2003 until 2008. Both cases are pending.

Both Murthy and Calisi are represented by Vickery, of Vickery, Waldner & Mallia LLP in Houston, who said he has “more than a dozen clients with legitimate legal claims involving Humira.”

Months of Injections

Pletan, 32, claims she developed small fiber peripheral neuropathy after receiving three months of Humira injections in 2008. The resulting “stabbing pains and hypersensitivity” in her feet forced her to give up outdoor activities and sell her family’s retail furniture store in Bozeman,Montana, when she could no longer work on her feet, she said in her complaint.

“The progression of the nerve damage seems to have stopped” after ceasing Humira injections, Pletan said in the filing. The nerve damage “appears to be permanent,” she said. Pletan is seeking both economic and punitive damages.

The case is Pletan v. Abbott Laboratories, 2011L004270, Circuit Court of Cook County, Illinois (Chicago).

To contact the reporters on this story: Laurel Brubaker Calkins in Houston atlaurel@calkins.us.com; Margaret Cronin Fisk in Southfield, Michigan, atmcfisk@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net