Just read Mina Kime's enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's. 

Newsweek has just released its list of the 500 greenest companies, including sector breakdowns. Here are the top pharma companies, headed up by J&J (number 3 overall) and Bristol-Myers Squibb.

No one is tracking pharma's social media presence better than WhyDotPharma, and the site/blog has done a nice review of which pharma companies are Twittering the most (Amgen, Boehringer, JNJ, Genentech), and how they're doing it. Some companies are using Twitter to establish a presence and get the word out on corporate news and policies, while others are using Twitter to follow and see what's being said about themselves and the industry.

Paul D’Eramo—former ISPE chair, a two-decade veteran of FDA, and current head of Quality and Compliance Worldwide for Johnson & Johnson—always has a finger on the pulse of the regulatory environment, and knows that GMPs are fluid, not static. “We are always searching for what the ‘c’ in cGMP is,” he says.

At October’s ISPE 2008 show in Boca Raton, Florida, D’Eramo offered his take on current trends that are shaping GMPs. Though not surprising, his are the words of experience and insight:

If you put credence in Swiss firm Covalence's annual ethics rankings, yes, GSK, BMS, and J&J are the most ethical companies in the Pharmaceuticals and Biotech sector. The list looks like this:

1. GSK

2. BMS

3. J&J

4. Abbott

5. Novartis

6. Roche

7. Boehringer Ingelheim

8. Astra Zeneca

9. Pfizer

A nice discussion recently on BNET with J&J's Joe Natale, who is heading up J&J's first foray into website entrepreneurship.

The past few months have seen renewed vigor from FDA's DDMAC (Division of Drug Marketing, Advertising, and Communications) in scrutinizing manufacturers' claims of safety and efficacy. In particular, DDMAC has cracked down on makers and marketers of ADHD medications for their alleged false and misleading claims.

FDA issued a press release today (see below), noting that the Agency is calling for safety-related labeling changes for three biopharmaceuticals used to treat certain types of anemia. The release suggests that erythropoiesis-stimulating agents (ESAs) may pose serious health risks and have questionable efficacy in alleviating symptoms of anemia and fatigue in cancer patients.

In addition to being a blow to Amgen, which manufactures the ESAs Aranesp, Epogen and Procrit (the latter of which is marketed by Johnson & Johnson's Ortho Biotech unit), this news likely dismayed Sandoz and other biopharma companies that earlier this year urged members of the Senate Committee on Health, Education, Labor and Pensions to accelerate approval of "biosimilars."

Wouldn't you love to be a fly on the wall in strategic planning meetings at Amgen, J&J, Sandoz and other biopharma companies during the next several weeks?

-HP
FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs) Nov. 9, 2007 -- The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure.

The labeling changes, which incorporate advice from FDA advisory committees and expand upon labeling changes made in March 2007, also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs.

Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer.  Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery and for the treatment of anemia caused by zidovudine (AZT) therapy in HIV patients.

For Patients with Cancer

For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a  hemoglobin level of 12 grams per deciliter (g/dL) or greater.The boxed warnings also emphasize that no clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer who receive an ESA dose that attempts to achieve a hemoglobin level of less than 12 g/dL. This is the hemoglobin level commonly achieved in clinical practice.Health care providers determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient’s red blood cells.An earlier boxed warning, approved in March, described the results of six studies demonstrating that survival was shorter and tumors progressed faster when ESAs were used to achieve hemoglobin levels of 12 g/dL or greater in cancer patients.Today’s new boxed warning also clarifies that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Moreover, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

“Health care professionals need to consider the risks of increased tumor progression and decreased survival in patients with cancer when prescribing ESAs,� said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director of its Center for Drug Evaluation and Research. “ESAs should be used in patients with cancer only when their anemia is due to chemotherapy and only at the lowest dose necessary to avoid the need for blood transfusions.�

The FDA is working with the manufacturer to design and conduct clinical trials of different dosing regimens and tumor types to further characterize potential tumor progression associated with ESAs.

For Patients with Chronic Kidney Failure

For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and for serious cardiovascular reactions such as stroke, heart attack or heart failure, the boxed warning states.

In addition to the boxed warning, the new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.

The new labeling also emphasizes that there are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being for patients with cancer or for patients with HIV undergoing AZT therapy.

In March 2007, the FDA approved labeling changes and issued a public health advisory outlining the new safety information about ESAs. Safety concerns regarding ESAs were discussed during May 2004 and May 2007 meetings of FDA’s Oncologic Drug Advisory Committee and a September 2007 joint meeting of FDA’s Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. ESA product labeling was previously revised in 1997, 2004 and 2005 to reflect new safety information.

The agency is currently reviewing a proposed Medication Guide that will better communicate the safety and effectiveness of ESAs to patients and will replace the existing patient labeling.

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. These drugs are manufactured by Amgen Inc., Thousand Oaks, Calif.  Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J, a subsidiary of Johnson & Johnson.

For more information:  http://www.fda.gov/cder/drug/infopage/RHE/default.htm

Penelope Przekop, Johnson & Johnson quality specialist and Six Sigma guru, seems to be adding a third specialty to her (black) belt - fiction. Her most recent publication, Aberrations, is a fictional novel that touches on narcolepsy, adultery, and homosexuality.

Intriguing.

The Six Sigma master has contributed articles and insight to PM for the past few years so we feel it only appropriate to report on her latest work. For Przekop's Six Sigma -related articles, visit our Six Sigma Library.

Twenty-one-year-old narcoleptic Angel Duet knows that her father, Frank, harbors secrets. But she doesn’t know that her entire life has been anchored around lies.

Frank’s suspicious refusal to discuss the past and his girlfriend’s sudden removal of the series of treasured photographs that have hung in the Duet’s foyer for more than twenty years causes Angel to become obsessed with searching for mysteriously guarded answers about her mother’s death. As she struggles to learn the truth and gain control over the narcolepsy that often fogs her world, Angel is exposed to new friends, co-workers, and lovers who introduce her to a dizzying realm of adultery, drugs, and homosexuality that further obscures reality.

To truly awaken, Angel must accept a truth she could never have dreamed up. Once she does, she realizes that sometimes the gifts we receive are not what we want—and only in time do we see their worth.

Is Przekop shifting her Six Sigma focus? I hope not...although I am in the market for a late summer beach read.

For more information on Przekop's works please visit her website.

MV

More sad news on pharma's restructuring. One comment from an anonymous insider: "American Home Products has gone from a headcount of over 7,000 to about 750.  This has to be a first." And, unfortunately, insiders believe that this is only the beginning. As MSN reports,

"Analyst Steve Brozak of WBB Securities says Wall Street is partly to blame. By unrealistically demanding the same double-digit profit growth the industry produced through the 1990s, big investors are forcing pharmaceutical companies to scuttle external research partnerships, then reduce head count and other expenses, Brozak said.

"You’re seeing senior VPs ... eliminated at these companies," replaced by junior people with less savvy but half the salary, he said.

More from the article

"...When the traditional safe bet among the big pharmaceutical companies, giant Johnson & Johnson, starts the biggest restructuring in its 121-year history, it’s clear things aren’t rosy for the industry.

J&J’s plan to cut up to 4,800 jobs follows news of tens of thousands of job cuts at Pfizer Inc., Bristol-Myers Squibb Co., Astra Zeneca PLC, Merck & Co. and Schering-Plough Corp.

Pfizer, the world’s biggest drug company, is eliminating 10,000 jobs, 10 percent of its work force. Merck is shedding 7,000 jobs, AstraZeneca is slashing 7,600 positions, Schering-Plough has furloughed about 1,100 manufacturing workers and Bristol-Myers Squibb will cut an unspecified number of jobs by year’s end.

For the full story (which was also published by Forbes and elsewhere), click here.

AMS