OIG and Justice Department Investigating Certain Blood Testing Labs for Kickback Arrangements
We outlined a special fraud alert that targeted the relationship between blood-testing laboratories and physicians. In it, the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services made clear that they will be scrutinizing labs who pay doctors who send in patient’s blood for testing as this arrangement raises a “substantial risk of friend and abuse under the anti-kickback statute.” The Wall Street Journal recently reported that this fraud alert is part of an investigation the OIG is conducting with the Justice Department into a number of specific laboratories’ practices.
As a ba...
Source: Policy and Medicine - September 11, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
PhRMA Proposes “Early Review” System for Reserving Proprietary Names to FDA
The Food and Drug Administration (FDA) recently invited public comment on plans to allow pharmaceutical companies to reserve proprietary names as early as the end of Phase II trials. According to Regulatory Focus, FDA has posted the Pharmaceutical Research and Manufacturers of America’s (PhRMA) proposal to its public docket, offering the public a glimpse at what could become the basis for the future drug name reservation system. The document can be found here. We previously wrote about FDA guidance and proprietary drug naming here.
Background
Regulatory Focus previously provided a succinct explanation of this drug naming...
Source: Policy and Medicine - September 10, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
OIG Releases Special Fraud Alert: Laboratory Payments to Referring Physicians
Many physicians and other healthcare providers refer a high volume of patient specimens to third party clinical laboratories every day. The Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services recently issued a Special Fraud Alert that addresses these relationship between labs and physicians.
The OIG’s Alert focuses on laboratories that may be violating the Federal Anti-Kickback Statute (AKS) in an effort to win business from referring physicians. OIG’s chief concern is that physicians will do business with the lab that pays the most, rather than the best lab, and that physicians w...
Source: Policy and Medicine - August 29, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
D.C. Circuit Court Reaffirms Attorney-Client Privilege in Internal Investigations
As reported by the law firm Husch Blackwell, a recent D.C. Circuit court decision reaffirms that the attorney-client privilege applies with equal force to internal investigations today as it did 30 years ago. We often cover compliance stories on our website and this issue is of particular importance for corporate compliance officers.
This decision vacates the March 6, 2014 district court decision in the same case. The lower court ruled that the attorney-client privilege did not protect documents developed during an internal investigation of potential fraud. The Court reasoned that investigations were ...
Source: Policy and Medicine - August 20, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Antitrust Lawsuit Against Celgene Over Thalomid and Revlimid Focuses on REMS Requirements
Celgene's successful cancer drugs Thalomid and Revlimid are at the center of an antitrust action. On April 3rd, Mylan Pharmaceuticals Inc. filed an antitrust lawsuit against Celgene Corporation in the U.S. District Court of New Jersey, accusing Celgene of blocking generic competition from Thalomid and Revlimid. Mylan accused Celgene of abusing their FDA Risk Evaluation and Mitigation Strategy requirements in order to monopolize the cancer drug market.
As a background, in 2007, the Food and Drug Administration Amendments Act (FDAAA) gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from man...
Source: Policy and Medicine - August 14, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Celgene Faces Off-Label Promotion Lawsuit Over Successful Cancer Drugs Thalomid and Revlimid
Since 2006, Celgene Corporation has earned $20.9 billion from the sales of two of its drugs—Thalomid and Revlimid. The drugs are used for patients suffering from multiple myeloma. This year, Celgene has posting amazing sales of Revlimid in particular—doctors are prescribing the drug as an effective cancer treatment with limited side effects. However, 2014 has also given rise to both an off-label suit stemming from before FDA recognized the drugs and antitrust allegations.
In February 2014, Celgene was accused of promoting its cancer drug Thalomid and related compound Revlimid for unapproved purposes. The accusations c...
Source: Policy and Medicine - August 14, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Aw, yeah.
I've been away from the blog again for way too long, and for no good reason. I'm still alive, still healthy, and training for three half marathons this spring. I'm happy to report that my M-spike is completely stable at 1.4, and that's even after my Revlimid dose was reduced to 10 mg.That means the Revlimid isAw, yeah. (Source: The Adventures of Cancer Girl)
Source: The Adventures of Cancer Girl - February 11, 2014 Category: Cancer Source Type: blogs
Perfect 10
I'm back on the blog, after realizing I forgot to post my latest M-spike update. If you're one of those who is interested in my M-spike updates, you'll remember that a few months ago, the lab didn't include my M-spike number with the rest of my results. That happened again, so I don't know what it is; however, they did check my IgG, which came back exactly the same as last month. The nurse was pretty impressed about how stable my IgG is, because usually IgG fluctuates all the time. The IgG measurement also includes healthy protein, while the M-spike number is only bad protein. I don't remember the exact number (am I s...
Source: The Adventures of Cancer Girl - January 10, 2014 Category: Cancer Source Type: blogs
ASH 2013 - Maintenance Matters
This study confirms again that they are correct - Rd thoroughly trounces MPT.
For those of us seniors with access to Revlimid, though, this study clearly demonstrates the advantage of Revlimid maintenance after initial therapy. It studied 1,623 newly-diagnosed myeloma patients over age 65 or ineligible for transplant, in three study arms: (A) Rd until disease progression; (B) Rd for 72 weeks or progression; and (C) MPT for 72 weeks or progression.
Some results for patients on continuous Rd versus those on 72-week Rd:
Median progression-free survival: 26 months versus 21 months.
Four-year overall survival: 59% ver...
Source: Myeloma Hope - December 11, 2013 Category: Cancer Source Type: blogs
ASH 2013 - Skip the Transplant
ASH is the American Society of Hematology, which has its annual meeting in early December each year, called the ASH Conference, or just ASH. I will be blogging on several topics, but this one, though it is "just" a poster talk and not an oral presentation, seems extremely important because it suggests a change in the standard of care for newly-diagnosed patients.
Paper 3180: Lenalidomide and Dexamethasone Alone Is Equivalent To Lenalidomide and Dexamethasone With Autologous Stem Cell Transplant In Newly Diagnosed Multiple Myeloma: Interim Study Results Of a Randomized Trial.
The authors are from Columbia University...
Source: Myeloma Hope - December 10, 2013 Category: Cancer Source Type: blogs
Held Hostage By Big Pharma
Firms like Celgene make the NHS pay absurd prices for medicines that are cheap to make. They're telling us to pay up or watch people like me die, argues MIKE MARQUSEEIn recent months I've been taking a medication called Revlimid, given as a "late therapy" for multiple myeloma.Since it looks like I may be Revlimid-dependent for a while, I decided to educate myself about the drug. As the chemistry is beyond me, I focused my attention elsewhere.The first thing I discovered was that Revlimid is phenomenally expensive.A single 21-day cycle of treatment at the lowest dose of 5mg daily costs the NHS £3,570. As the dose rises, so...
Source: PharmaGossip - November 19, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Smoldering myeloma requiring treatment: time for a new definition? Introductory notes.
I know I haven’t been posting anything related to myeloma lately…and that has been bothering me a lot. And so I’ve been trying really hard to concentrate.
I began writing this post about ten days ago, but I just haven’t been able to finish it.
So today I decided to write a different sort of post: a post about why I can’t write a post.
It reminds me of the time when I signed up for an American Sign Language course. I was fresh out of college, so that’s QUITE a few years ago…Anyway, I loved my ASL course and was an eager student. Our first assignment was to go shopping in a supermarket and ...
Source: Margaret's Corner - November 16, 2013 Category: Cancer Authors: Margaret Tags: Blogroll myeloma PETHEMA Source Type: blogs
My hemoglobin can beat up your hemoglobin
If you've read my blog for a while, you know I spent years struggling with low hemoglobin (iron) levels caused by Revlimid and by the myeloma itself. Over the past year or two, though, my hemoglobin has been steadily improving. My hemoglobin is now at a never-before-seen number that I didn't even know was physically possible for me:All must bow down before my Almighty Hemoglobin!My nurse practitioner thinks all of my running has improved my blood counts. So I guess as long as I can keep up the marathon training for, oh, the rest of my life, I'll be just fine. (Source: The Adventures of Cancer Girl)
Source: The Adventures of Cancer Girl - October 10, 2013 Category: Cancer Source Type: blogs
The case of the missing M-spike
I had all of my blood tests done last week, and I was told that the doctor's office has just switched to a new lab so there could be a few hiccups along the way. The whole Revlimid process went beautifully (woo!), but the nurse could not find my M-spike. Did they not test it? Has it gotten so tiny that it accidentally got thrown out in the back yard and now must make its way home through a jungle of grass and killer ants like in Honey I Shrunk the Kids? Nobody knows. I'm sure it is totally fine. If it doesn't turn up soon, I'll be getting tested again in three weeks anyway. No worries.Oh! Theeeeeere it is! (Source: The Adv...
Source: The Adventures of Cancer Girl - August 21, 2013 Category: Cancer Source Type: blogs
Celgene Halts Revlimid Trial Over Patient Deaths, Prompting Investor Anxiety
In a setback to expanding the market for its flagship drug, Celgene has ended a Phase III trial of Revlimid, which was being tested in elderly patients with a type of blood cancer known as B-cell chronic lymphocytic leukemia, because there were a larger number of deaths than among those given a rival treatment. The FDA called for an end to the study on July 12, according to a company statement.
Specifically, there were 34 deaths out of 210 patients who were given Revlimid compared to 18 deaths out of 211 patients given Leukeran, which is marketed by GlaxoSmithKline. The study enrolled people who were 65 years or older, suf...
Source: Pharmalot - July 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
