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Risk of Cancer Counterfeits due to Drug Shortages

Cancer Injection Medications 1.17.12

 FDA has issued a warning raising concerns about the shortages of injectable cancer medications leading to unlicensed solicitations of non-FDA approved products directly to clinicians. The FDA announced that they were aware of the purchase of these unapproved injectable cancer medications to clinicians that were most likely administered to patients.

Examples of products include unapproved versions of FDA-approved medications such as Faslodex (fulvestrant), Neupogen (filgrastim), Rituxan (rituximab) and Herceptin (trastuzumab). The products purchased could have been affected if they were not stored or transported under certain temperatures. By administering these products to patients, healthcare providers are putting their patients at risk.

The FDA announced, “Health care providers should be aware that purchasing medications from direct-to-clinic promotions that are from non-verified sources might increase the risk of receiving a potentially unsafe and ineffective product, since the products offered for sale may be unapproved, not manufactured with the quality attributes of FDA-approved products, or counterfeit.”

Record drug shortages in the U.S. are causing some hospitals and clinics to use less-effective medicines, according to doctors and pharmacists. The FDA has arranged to import foreign versions of life-saving drugs that are in short supply, the agency said.

Under certain circumstances, The FDA can authorize some importation of medications, which are in short supply.

For the full warning & how healthcare professionals can help ensure safety of their patients visit:

http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM287717.pdf

New Potential Therapy Approach for Hepatitis C Found

HCV 1.17.12

 A new way to block infection from hepatitis C virus (HCV) in the liver that could possibly lead to new therapies for people affected by this and other infectious diseases was found by Researchers at the University of British Columbia.

Hepatitis C, the disease caused by chronic HCV infection affects over 170 million people worldwide. This disease is one of the leading causes of liver transplant and liver cancer. It is spread by blood-to-blood contact. Currently, there is no preventative vaccine. The treatments for the disease cause serious side effects and are only moderately effective.

"As HCV infects a person, it needs fat droplets in the liver to form new virus particles," says François Jean, Associate Professor in the Department of Microbiology and Immunology and Scientific Director of the Facility for Infectious Disease and Epidemic Research (FINDER) at UBC. "In the process, it causes fat to accumulate in the liver and ultimately leads to chronic dysfunction of the organ."

"HCV is constantly mutating, which makes it difficult to develop antiviral therapies that target the virus itself," says Jean.

Jean and his team decided to take a different approach and developed an inhibitor, which reduced the size of host fat droplets in liver cells and stops HCV from multiplying, taking residence, and infecting other cells.

"Our approach would essentially block the lifecycle of the virus so that it cannot spread and cause further damage to the liver," says Jean.

This new approach may translate into similar therapies for other life threatening infections in humans.

For more information on this study, please visit:

http://www.plospathogens.org/article/info:doi/10.1371/journal.ppat.1002468.

First Clinical Trial Site Initiated in CSL Behring Phase II/III Pivotal Study of Recombinant Fusion Protein Linking Coagulation Factor IX with Recombinant Albumin

 CSL Behring 1.16.12Vienna, Austria — 12 January 2012

CSL Behring has announced that the first site has been initiated in its global phase II/III, multi-center study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The site is located in Vienna, Austria. The prospective, open-label study will enroll adolescents and adults (12 – 65 years) who have hemophilia B. CSL Behring, in collaboration with its parent company, CSL Limited (ASX:CSL), is developing rIX-FP for the prophylaxis and treatment of bleeding episodes in patients with congenital Factor IX (FIX) deficiency as part of the PROLONG-9FP clinical study program.

"The unmet medical need is great for a factor IX product with an extended half-life for use in treating people with hemophilia B, a life-long, debilitating clotting disorder," said Russell Basser, MD, Senior Vice President, Global Clinical R&D at CSL Behring. "Such a therapy can mean fewer injections for patients, and may enable or enhance prophylactic treatment. This would be an improved convenience that may result in a better quality of life for patients."

"We have entered a very exciting and promising era for patients with hemophilia," said Elena Santagostino, MD, Principal Investigator for the study. "A recombinant factor IX product with a longer half-life, such as the product that CSL Behring is developing, will have the potential to prevent bleeds in people who have hemophilia B. Today, these individuals generally must undergo frequent infusions of factor product to effectively manage their condition. Such a routine tends to present challenges; maintaining adherence to it can be difficult and one’s quality of life can therefore be impacted. The product in development today aims to reduce the number of infusions a patient with hemophilia must undergo. As treating physicians and clinical researchers, we are proud to be a part of this effort and look forward with great anticipation to the results of our research."

To date, the PROLONG-9FP program has established study sites in Austria, Bulgaria, France, Germany, Italy, Spain and in Israel. It is anticipated that in coming months additional trial sites will be established in the United States, Japan, and Russia.

CSL Behring and CSL have engineered rIX-FP to extend the half life of Factor IX while minimizing any tolerability issues. In the process, recombinant albumin—a protein with an inherently long half-life—is used as a fusion partner. A specifically designed linker connects the recombinant factor IX and recombinant albumin as a means of optimizing the efficacy of rIX-FP.

The Phase II/III study consists of a screening period, a pharmacokinetic (PK) evaluation period, followed by an approximate 12-month safety and efficacy evaluation period with rIX-FP. A surgical prophylaxis sub-trial is included. More information can be found at http://clinicaltrials.gov/ct2/results?term=rIX-FP+.

FDA Issues Warning Against Drug Brentuximab

BrentuximabJanuary 13, 2012 — Today, the US Food and Drug Administration (FDA) has issued a warning to healthcare professionals about the lymphoma drug brentuximab (Adcetris, Seattle Genetics).

There has been two new reported cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. According to the FDA, due to the seriousness of PML, which can result in death, a new boxed warning, which highlights this risk has been added to the drug label.

There was also a contraindication added, which warned about the increased risk for pulmonary toxicity when combining the use of brentuximab with bleomycin, a cancer drug.

The FDA approved Brentuximab in August 2011, for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma. When first approved, 1 case of PML was listed in the warnings & precautions sector of the label. Now there are 3 cases associated with the drug.

Signs and symptoms of PML can include changes in mood or usual behavior; confusion; thinking problems; loss of memory; changes in vision, speech or walking; and decreased strength or weakness on one side of the body. The signs and symptoms can develop over the course of several weeks or months, the FDA says.

If PML is suspected healthcare professionals should temporarily stop brentuximab dosing. If a diagnosis of PML is confirmed, the healthcare professional should discontinue the drug therapy.

When study results were presented at the American Society of Hematology annual meeting in 2010, Brentuximab was very well perceived among experts. They expressed excitement about the drug being the first FDA approved for Hodgkin’s lymphoma in over 30 years.

More information about today's FDA announcement is available on the agency's Web site.

FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Prescription Price Case Settled for CVS

After over two years of investigation, on Thursday, CVS Caremark agreed to pay $5 million to settle charges by the Federal Trade Commission that the company had misrepresented the price of certain prescription drugs in one of its Medicare drug plans, which had caused many older consumers to pay a significant higher price than what was advertised.

This settlement has come during a time of comprehensive government surveillance of PMB’s like CVS Caremark. At this time, the Federal Trade Commission is reviewing the merge of Medco Health and Express Scripts. Regulators are exploring if this merge would consist of too much market share.

In CVS Caremark case, they investigated if the merger of one of the largest pharmacy drugstore chains and one of the largest PBM’s would give the company an unwarranted competitive advantage in the marketplace. By having a network of roughly 65,000 pharmacies CVS Caremark would benefit by having an unfair advantage of access to information about competing pharmacies and influencing customers.

In early 2009, the F.T.C opened an investigation on CVS Caremark due to labor unions, pharmacies, legislators, and some consumer groups concern about anticompetitive and anticonsumer business practices.

The F.T.C. only found one violation against what was once RxAmerica, one of the company’s Medicare drug plans. They had misrepresented drug prices to some of their consumers.

Thursday, the agency dismissed the allegations of anticompetitive behavior. “After a thorough and comprehensive review of other consumer protection and competition issues in this matter, the F.T.C. issued a letter closing the investigation,” the agency said in a news release.

CVS Caremark stated that RxAmerica had posted incorrect prices for some generic drugs. This was placed on a website, which was maintained by the Centers for Medicare and Medicaid Services. The company fixed the pricing problem once they learned of the mistake.

CVS Caremark was in discussions with attorneys general of 24 states, as well as the District of Columbia in regards to resolving this multistate investigation in a parallel manner.

“CVS Caremark is pleased to have reached an agreement with the F.T.C. that ends the investigation and enables us to continue our focus on offering unique, innovative products and services that differentiate us and benefit consumers,” said Larry Merlo, the chief executive of CVS Caremark, in the statement.

When CVS proposed to merge with Caremark in 2006, they pledged to put up a firewall to keep its stores separate from the PBM’s. Pharmacies and consumer groups complained to regulators that the two segments of the company had shared consumers’ records. This caused people to go to the retail stores as well as order through their mail-order operations, giving CVS Caremark a greater advantage over their competitors. Competitors complained that this was an unfair advantage.

In the statement, Douglas A. Sgarro, the chief legal officer of CVS Caremark, said, “It is important to note that, at the conclusion of this comprehensive investigation, the F.T.C. made no allegations of antitrust law violations or anticompetitive behavior associated with any of our business practices, products or service offerings.”

The Federal Trade Commission’s decision will eliminate an immense amount of overhang for CVS Caremark with the final decision for only citing CVS Caremark for the RxAmerica violation.

The National Community Pharmacists Association said they were upset with the lack of action to protect consumers and market competition.

“The union of these companies further compounds the inherent, ‘the fox is guarding the henhouse’ problem with today’s prescription drug benefit system,” B. Douglas Hoey, the chief executive of the association, stated.

The F.T.C. complaint charged that from 2007 through at least November 2008, the RxAmerica plan put on their Web site and provided to some third-party Web sites incorrect prices for Medicare Part D prescription drugs at two pharmacy chains, CVS and Walgreens.

This caused many people to choose Caremark plan and pay as much as 10 times more than expected, according to the F.T.C. In some cases, the higher prices unexpectedly pushed older consumers into a gap in prescription drug coverage that requires people to pay out of pocket for their medicines.

CVS Caremark has to pay $5 million to reimburse their consumers for the price difference. They are also barred from making deceptive claims about drug prices. The agency said it planned to mail checks to consumers who were affected by this deception.

Source

http://www.nytimes.com/2012/01/13/business/cvs-caremark-settles-charges-over-prescription-prices.html?pagewanted=2

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