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:

'via Blog this'

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."

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.