GSK China’s bribery scandal resolved with heavy sentence

 A few months ago, GlaxoSmithKline was shamefaced with its scandal in China, involving embezzlement of public property and bribery to then deputy health commission chief, Dr. Fengping Huang.

A majority of hospitals in China are state-run and are financially, minimally supported by the government. To supplement their unsatisfactory income, doctors often accept a sum to prioritize patients who require expensive treatments or surgeries. And new drug approvals or clinical trials in China are often the toughest barriers with its ambiguity and slow process due to sophisticated hierarchy within regulatory bodies.
Dr. Huang was arrested in late 2013. A year later, the drug maker was fined the ‘biggest such penalty ever imposed by a Chinese court’: $492 million. And just this month, Dr. Huang has been sentenced to 19 years of imprisonment.  The heavy decree of punishment imposed by the Chinese court supports the country’s efforts to encourage integrity. Clearer regulations, transparency and reduced (or the absence of) corruption will give China a better reputation in the global biopharma industry.

Six Commonly Missed Diagnoses: B12 Deficiency

You’re pretty sure you know your body and you tell your doctor you’re just not feeling right. You’re tired, maybe a little depressed, a bit achy. Maybe your digestion is “off.” The list of foods you can’t seem to enjoy is definitely longer. Your doctor’s empathic, not at all dismissive of your symptoms, but after a physical exam and some apparently appropriate tests she can’t find anything really wrong.

On the surface, this is reassuring. After all, the main reason we do go to doctors is to ascertain that nothing serious is going on. Still, could she be overlooking something?

After decades of treating patients with longstanding but undiagnosed chronic symptoms, here’s the first of six overlooked diagnoses I see most frequently in our patients at WholeHealth Chicago.

Low Levels of Vitamin B-12
One of the eight B vitamins, B-12 is involved in the metabolism of every cell in your body. Years ago B-12 was called “maturation factor” because cells need B-12 to mature from being young and ineffectual whippersnappers to fully functioning and mature.

B-12 deficiencies affect three major systems in your body: your blood, nervous system, and, less often, gastrointestinal tract. These three are targets because their cells either have a high turnover rate (blood and intestinal lining) or need a lot of B-12 to function smoothly (nervous system). The symptoms of low B-12 levels are related to each of these areas.

    Low B-12’s effect on your blood is a specific type of anemia called megaloblastic anemia (as distinct from the more common iron deficiency anemia). A megaloblast is an immature, undeveloped red blood cell, large and bulky (megalo=large, blast=immature form). Remember, B-12 is needed for this cell to mature, so with insufficient B-12 megaloblasts accumulate in your blood. Symptoms are the same as for anemia from any cause, including fatigue, breathlessness, and lightheadedness. Your skin becomes a pale yellow, most likely because the red cells that do make it to maturity are very fragile and easily broken, releasing their yellow bilirubin pigment.

    In your nervous system, B-12 deficiency causes symptoms affecting your nerves (numbness, tingling, tremors, balance problems) and your mind (depression, brain fog, mood swings, and, in rare cases, hallucinations and psychosis).

    In your gastrointestinal tract, you might experience digestive symptoms and weight loss because you’re not absorbing food efficiently.

The irony is that with all these there’s usually just one predominant symptom, and making a connection to low B-12 can easily be delayed until other symptoms start to appear. For example, if your only symptom is tingling in your hands, you might undergo all sorts of diagnostic tests before your doctor thinks “Maybe we should check her B-12 level.”

What causes B-12 deficiency?
The list of causes is lengthy, but by far the most frequent culprit is a dietary one. Vegetarians who aren’t paying attention to the B-12 in their food choices will have downward-drifting B-12 levels, and virtually all vegans not taking Vitamin B-12 supplements ultimately develop deficiencies. Even the various vegan organizations acknowledge it’s not possible to get adequate B-12 while following a strictly vegan diet, and that’s because the richest sources are animal products.

Other causes of B-12 deficiency include pernicious anemia, an uncommon (and spookily named) autoimmune disease that destroys parietal stomach cells. These cells produce a substance called intrinsic factor, necessary for B-12 absorption. Also, since you need stomach acid to absorb B-12, long-term use of acid-suppressing proton pump inhibitors (Nexium, etc.) can lead to B-12 deficiency, as can chronic intestinal conditions like Crohn’s disease, celiac disease, and intestinal parasites.

The missed diagnosis
The main danger of missing this diagnosis is that (while quite rare) the damage to your nerves and even brain can be permanent. Other serious consequences: your anemia can get so severe it causes heart failure and collapse. Or you could be misdiagnosed with a major depressive disorder or even psychosis and take unneeded psychiatric medications for months (or years) before someone notices you look yellow-ish and you’re finally diagnosed with megaloblastic anemia.

There are four reasons why this diagnosis is missed:

    Although it’s not an expensive test, B-12 isn’t measured during routine blood tests. Doctors generally don’t order a B-12 evaluation if there’s no evidence of anemia (which would be picked up on a routine blood test). However, the fatigue and nervous system and gastrointestinal symptoms can precede anemia by months.
    Doctors rarely ask (and patients rarely volunteer) information about their eating habits. In medical school, we’re taught that the US diet is “plenty good enough to prevent any vitamin deficiencies.” To which I now respond, “Ha!” I agree most of us eat plenty of food (obesity levels are still on the rise), but it’s often food whose nutritional value has been castrated. Also, all vegetarians and vegans should be regularly tested for possible B-12 deficiency, but if your doc doesn’t know your eating habits you won’t be tested.
    Like many blood tests, there’s considerable disagreement about normal levels of B-12. Most labs test B-12 levels between 200 pg/ml (picograms per milliliter) and 800 pg/ml. Someone at 250 pg/ml would be classified as normal, but symptoms can start appearing at 350 pg/ml. In Japan, normal B-12 was recently raised to 500 pg/ml and higher. We’ll see this type of erroneous overreliance on “normals” in other frequently missed diagnoses, like hypothyroidism, vitamin D deficiency, gluten intolerance, adrenal fatigue.
    Taking the B vitamin folic acid (folate) or eating a lot of folate-containing foods without adding B-12 can actually mask the symptoms of a developing B-12 deficiency. Although folate will keep your blood count normal even if your B-12 is falling, the folate will not protect your brain and nervous system. You’ll have no evidence of megaloblastic anemia (because of the folate), but your symptoms of numbness, tingling, balance problems, and emotional issues will continue unchecked. By eating so many folate-containing green vegetables, beans, and lentils, vegetarians and vegans inadvertently mask their own slowly developing B-12 deficiency.

Treatment is easy
It’s virtually impossible to take too much B-12 as any excess of this water-soluble vitamin is eliminated via urine. Nutritional guru Alan Gaby, MD, has commented that the only way too much B-12 will kill you is if you fill your bathtub with it and drown.

Foods high in B-12 are animal products: meat, poultry, seafood, dairy, and eggs, with eggs having the least. Because all animals store B-12 in their livers, eating liver is an excellent (though not particularly popular) treatment for B-12 deficiency. Your grandmother or great-grandmother likely remembers a time when her doctor told someone in the family to eat more liver.

And since people with low B-12 are likely to also have gastrointestinal symptoms that interfere with B-12 absorption, the best way to quickly increase (and maintain) B-12 levels are with B-12 injections, chewable tablets, or the recently released nasal sprays and skin patches.

In my own practice, a deficient patient receives a series of four B-12 injections (or four B-12 containing Meyer’s Cocktails) and also starts (and maintains herself on) a daily B-12 chewable tablet. Usually within a month her levels are back to normal.

There’s more to come in the Commonly Missed Diagnoses series. Next week: overlooked diagnosis #2, vitamin D deficiency

Be well,

David Edelberg, MD

Why Can't People Live For Over 900 Years of Age Now?

The Bible teaches quite plainly that the early patriarchs often lived to be nearly 1,000 years old and even had children when they were several hundred years old! “Methuseleh lived 900 years but these stories you’re liable to read in the Bible, they ain’t necessarily so.”1

Along with American composer George Gershwin, many people find it difficult to believe that Methuselah lived to be 969 years old. Nevertheless, the Bible teaches quite plainly that the early patriarchs often lived to be nearly 1,000 years old and even had children when they were several hundred years old! Similar claims of long life spans are found in the secular literature of several ancient cultures (including the Babylonians, Greeks, Romans, Indians, and Chinese). But even a life span of nearly 1,000 years is sadly abbreviated when we consider that God initially created us to live forever.

For 1,500 years after creation, men lived such long lives that most were either contemporaries of the first man, Adam, or personally knew someone who was! The ten patriarchs (excluding Enoch) who preceded the Great Flood lived an average of 912 years. Lamech died the youngest at the age of 777, and Methuselah lived to be the oldest at 969.

Table 1. Ages of the Patriarchs from Adam to Noah

	Patriarch	Age	Bible Reference
1	Adam	930	Genesis 5:4
2	Seth	912	Genesis 5:8
3	Enosh	905	Genesis 5:11
4	Cainan	910	Genesis 5:14
5	Mahalalel	895	Genesis 5:17
6	Jared	962	Genesis 5:20
7	Enoch	365 (translated)	Genesis 5:23
8	Methuselah	969	Genesis 5:27
9	Lamech	777	Genesis 5:31
10	Noah	950	Genesis 9:29

During the 1,000 years following the Flood, however, the Bible records a progressive decline in the life span of the patriarchs, from Noah who lived to be 950 years old until Abraham at 175 (see figure 1 and table 2). In fact, Moses was unusually old for his time (120 years) because, when he reflected on the brevity of life, he said: “The days of our lives are seventy years; and if by reason of strength they are eighty years, yet their boast is only labor and sorrow; for it is soon cut off, and we fly away” (Psalm 90:10).

Table 2. Ages of the Patriarchs after Noah to Abraham

	Patriarch	Age	Bible Reference
11	Shem	600	Genesis 11:10–11
12	Arphaxad	438	Genesis 11:12–13
13	Shelah	433	Genesis 11:14–15
14	Eber	464	Genesis 11:16–17
15	Peleg	239	Genesis 11:18–19
16	Reu	239	Genesis 11:20–21
17	Serug	230	Genesis 11:22–23
18	Nahor	148	Genesis 11:24–25
19	Terah	205	Genesis 11:32
20	Abraham	175	Genesis 25:7

Extrabiblical evidence to support the long life spans of the people in Genesis is found in the Sumerian King List. This list mentions a flood and gives the length of the reigns of kings before and after a flood.

Today, man’s maximum life span is about 120 years, and our average life expectancy is still only 70–80 years—just as it was when the 90th Psalm was written 3,400 years ago! The precipitous plunge in life spans after the Flood suggests that something changed at the time of the Flood, or shortly thereafter, that was responsible for this decline. A line graph of this decline reveals an exponential curve.

Biological Causes of Aging

What exactly causes this process of aging in our body? Although the mechanism of aging (and its prevention) has long been an object of biomedical research, science still has no definitive answer to this question. Around the turn of the century, it was believed that aging didn’t directly involve the living cells of our body but rather was an extracellular phenomenon. It was believed that our normal living cells, if properly nourished, could grow and divide indefinitely outside our body. In 1961, this idea was refuted by Leonard Hayflick, who grew human cells outside the body in covered glass dishes containing the necessary nutrients. Hayflick discovered that cells cultured in this way normally died after about 50 cell divisions (Hayflick’s limit). This suggests that even the individual cells of our body are mortal, apart from any other bodily influence.

Genetic Determinants

Both aging and life span are processes that have genetic determinants that are overlapping and unique. Approximately 20–30 percent of factors affecting life span are thought to be heritable and thus genetic. Life span varies greatly among individuals, indicating that while aging plays a role, other factors are also involved. Telomeres, which are long, repetitive sequences of DNA at the ends of human chromosomes, are also thought to play an important role in aging. With each division of the cell, telomeres shorten due to the inability of the enzyme that copies the DNA to go all the way to the end of the chromosome. When telomeres have become too short, the cell stops dividing. This limitation plausibly serves as a quality control mechanism. Older cells will have accumulated many mutations in their DNA, and their continued division may lead to diseases like cancer. Most body cells cannot replicate indefinitely, leading to aging and eventually death. Thus, telomeres are important in determining the life span of cell types that directly affect aging.

Physiological Determinants

In one sense, most of the substance of our body really doesn’t continue to get older during our life: a great many of our body’s parts are constantly repairing and replacing themselves. The epidermal cells that cover the entire surface of our skin, for example, never get older than one month. New cells are continually produced (by cell division) deep in the epidermis, while the older ones continually slough off at the surface. Similarly, the cells lining our intestines completely replace themselves every 4 days; our red blood cells are entirely replaced about every 90 days; and our white blood cells are replaced about every week.

Even cells that never (or rarely) divide, such as cardiac muscle cells and brain cells, turn over molecule by molecule. It is believed that little or nothing in our body is more than about 10 years old. Thus, thanks to cell turnover and replacement, most of the organs in the body of a 90-year-old man are perhaps no older than those of a child. Indeed, you might say our body never actually grows older.
It’s rather like the story about “grandpa’s ax.” It seems a man had an old ax that hung over his fireplace and which he claimed had been passed down in his family for five generations. When asked how old the ax was, he said he wasn’t sure because although his great-great-great-great grandfather bought the ax about 300 years ago, he also understood that over the years, the ax had 6 new heads and 12 new handles. Our bodies are something like grandpa’s ax in that we too are constantly replacing “heads and handles,” and in a sense we never get older.

Is it even possible for anyone to age and die if the body constantly repairs and replaces its parts? At this point we might be inclined to ask, why did Methuselah die so young? How, indeed, is it even possible for anyone to age and die if the body constantly repairs and replaces its parts? Surely, if our automobile could do this, we would expect it to last forever. Part of the answer may be that certain key parts of our body fail to repair or replace themselves. Our critically important heart muscle cells, for example, fail to multiply, repair, or replace themselves after birth (although, like all muscle cells, they can increase in size). This is why any disruption in the blood supply to the heart muscle during a heart attack leads to permanent death of that part of the heart. The nerve cells of our brain—including those of our eye and inner ear—also fail to multiply or repair themselves. From the time of our birth to the end of our life, we lose thousands of nerve cells a minute from our central nervous system, and we can never replace them. As we get older, this causes a progressive loss of our ability to hear, see, smell, taste, and and even remember things?

The important point is that science offers no hope for eternal life, or even for the significant lengthening of life. It has been estimated that if complete cures, or preventions, were found for the three major killers (cancer, stroke, and coronary artery disease), the maximum life span of man would still not increase (although more people would approach this maximum). And such long-lived people would still become progressively weaker with age, as critical components of their body continue to deteriorate.

Adapted from: Did People Like Adam and Noah Really Live Over 900 Years of Age? by Dr. Georgia Purdom and Dr. David Menton on May 27, 2010

1. George Gershwin, “It Ain't Necessarily So,” Porgy & Bess, 1934. 

Bayer Appoints Cardinal Health as U.S. Based Contract Manufacturer for Xofigo® (radium Ra 223 dichloride) Injection

Cardinal Health to build 64,000 square foot, state-of-the-art facility to manufacture radioactive therapeutic agent used to treat patients with bone metastases from castration-resistant prostate cancer

WHIPPANY, N.J. and DUBLIN, Ohio, Dec. 18, 2014 /PRNewswire/ -- Bayer HealthCare and Cardinal Health today announced the signing of a 15-year agreement for the contract manufacturing of Xofigo^® (radium Ra 223 dichloride).  As part of the agreement, Cardinal Health will build a state-of-the art, 64,000 square foot facility in Indianapolis, which will be dedicated exclusively to the manufacturing of Xofigo.  Product manufactured at this facility will primarily be distributed in the United States and Canada.

The manufacturing facility will be built near and leverage the capabilities and talent of Cardinal Health's existing Indianapolis radiopharmacy, which is one of the two U.S. locations authorized by Bayer HealthCare to distribute Xofigo. Cardinal Health is the sole distributor of Xofigo in the U.S.

Xofigo is an alpha-particle-emitting radioactive therapeutic agent for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Bayer HealthCare is developing and marketing Xofigo worldwide. The current manufacturing site in Norway will continue to be responsible for global supply of the product. 

"This new agreement presents us with an excellent opportunity to leverage our unmatched expertise in the nuclear pharmacy industry to expand access to a therapeutic agent," said Tiffany Olson, president of Cardinal Health's Nuclear Pharmacy Services business. "We look forward to continuing to strengthen our relationship with Bayer HealthCare, and to developing innovative services to expand the use of radiopharmaceuticals in the United States and Canada."

Bayer had started the preparations for a second manufacturing site soon after the first marketing authorization for Xofigo was obtained in May 2013. The new Cardinal Health manufacturing facility, slated for completion in 2017, will be built and equipped for the unique manufacturing needs of Xofigo.  It will be supported by approximately 85 employees, including specialized manufacturing roles, chemists, engineers and other professional positions.

"Cardinal Health has played a pivotal role in distributing Xofigo to medical facilities since the product's launch in the U.S. in May 2013," said Shannon Campbell, vice president and general manager of oncology, Bayer HealthCare. "Cardinal Health's proven track record in radiopharmaceuticals and their experience with Xofigo make them a formidable choice for helping to expand our manufacturing capabilities in North America.  We're pleased to take this important step forward alongside Cardinal Health."

About Castration-Resistant Prostate Cancer (CRPC) and Bone Metastases
Prostate cancer is the most common cancer among men in the United States (other than skin cancer).  Approximately four percent of prostate cancer cases are considered distant, which means that the cancer has spread beyond the prostate to distant areas of the body (metastasized). If prostate cancer starts to spread to other areas of the body, it most commonly goes to the bone. Once the cancer has reached the bone, interactions between tumors cells and the bone cells responsible for breaking down and rebuilding bone result in excessive bone rebuilding.

About Xofigo^® (radium Ra 223 dichloride) Injection Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of Xofigo may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium Ra 223 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue¹.

The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, Xofigo significantly improved overall survival (OS) [HR=0.695 (95% CI 0.552-0.875), p=0.00185]; median OS was 14.0 months with Xofigo plus best standard of care (95% CI 12.1, 15.8) vs. 11.2 months with placebo plus best standard of care (95% CI 9.0, 13.2).¹ Additionally, at the interim analysis there was a delay in time to first symptomatic skeletal event (SSE) for patients treated with Xofigo vs. placebo. The majority of events consisted of external beam radiotherapy to bone metastases

An exploratory updated overall survival analysis performed before patient crossover with an additional 214 events resulted in findings consistent with the interim analysis. The updated analysis showed improvement in overall survival (OS), with a median OS of 14.9 months with Xofigo (95% CI 13.9, 16.1) vs. 11.3 months with placebo (95% CI 10.4, 12.8) [HR=0.695 (95% CI 0.581-0.832)].¹

Important Safety Information for Xofigo^® (radium Ra 223 dichloride) Injection

• Contraindications: Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman.
• Bone Marrow Suppression: In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression – notably thrombocytopenia, neutropenia, pancytopenia, and leucopenia – has been reported in patients treated with Xofigo.
  Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure.
• Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be >1.5 × 10⁹/L, the platelet count >100 × 10⁹/L, and hemoglobin >10 g/dL. Prior to subsequent administrations, the ANC should be >1 × 10⁹/L and the platelet count >50 × 10⁹/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care.
• Concomitant Use with Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued.
• Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations.
• Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients' oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia
• Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo
• Secondary Malignant Neoplasms: Xofigo contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium -223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow up for patients on the trial
• Subsequent Treatment with Cytotoxic Chemotherapy: In the randomized clinical trial, 16% patients in the Xofigo group and 18% patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy
• Adverse Reactions: The most common adverse reactions (>10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (>10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%).

For full prescribing information visit http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf

About Cardinal Health Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $91 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products and services to more than 100,000 locations each day and is also the industry-leading direct-to-home medical supplies distributor. The company is a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company operates the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #22 on the Fortune 500, Cardinal Health employs 34,000 people worldwide. More information about the company may be found at www.cardinalhealth.com and @CardinalHealth on Twitter.

About Bayer HealthCare Pharmaceuticals Inc.  Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals Inc. provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

© 2014 Bayer HealthCare Pharmaceuticals Inc. 
BAYER, the Bayer Cross, and Xofigo are registered trademarks of Bayer.               

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

1. XOFIGO® (radium Ra 223 dichloride) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, May 2013.

SOURCE Cardinal Health

Moving towards Regulatory Harmonisation to enhance Access to Medicines in Africa

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Moving towards Regulatory Harmonisation to enhance Access to Medicines in Africa

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This is the 4th African Regulatory Conference (ARC) co-organised by the Drug Information Association (DIA) and the IFPMA’s African Regulatory Network (ARN).
IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) represents the research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry’s 1.3 million employees strive to develop and provide innovative medicines, biological products, and vaccines that improve patients’ lives worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.
The ARN is an ad-hoc network of the Regulatory Policy and Technical Standards Committee (RPTS) of IFPMA. The association works in partnership with regulatory authorities and the pharmaceutical industry in Africa to encourage greater harmonisation of regulatory requirements with the aim to help enable faster and expanded access to good quality innovative medicines for patients.
The ARC offers the opportunity for key stakeholders active in the region including Representatives from health authorities, local and multinational pharmaceutical companies, international, governmental and non-governmental organisations to exchange progressive views on key topics of interest and identify focus areas for ongoing efforts aimed to increase patient access to new and improved medicines.
Simultaneous translation in French and English will be available.
To view detailed programme please click on View PDF above.

Smart drug Modafinil may help those lacking creativity but does not help intelligent people improve results, study claims

By Victoria Ward

Smart drugs can boost the performance of those who are lacking in creativity but do not help those who are academically bright, a study has found.

A survey suggested that one in five students have taken so-called “wake-up drug” Modafinil to boost their ability to study and improve their chances of exam success.

The study, published in the journal Plos One, involved 64 people, half of whom were given a placebo.

Dr Ahmed Dahir Mohamed, from the University of Nottingham, found that by taking the drug, those who were not creative were able to improve their performance in problem solving.

But healthy people functioning at the optimum level found their performance impaired.

Experimental Ebola Drugs Face Ethical Questions Amid Clinical Trials.

Experimental Ebola Drugs Face Ethical Questions Amid Clinical Trials.

Nature (11/12, Hayden) explores the ethical concerns surrounding testing for experimental Ebola treatments. According to Nature, two trials taking place in Guinea and Liberia will announce this week whether or not some trial participants will receive a placebo during the testing for ZMapp, a treatment for Ebola. On November 11, NIH held a conference of researchers to consider US clinical trials, while on the same day in Geneva, Switzerland, the WHO held a similar meeting. The WHO concluded that because “standard of care” available in Africa is insufficient to keep patients alive, no control should be used. With plasma trials, controls can be selected among those patients for whom no serum match is available. Clifford Lane, deputy director for clinical research and special projects at NIAID said about the trials, “The idea that there’s no need for randomized, controlled trials presupposes that the drugs have zero side effects, that they are efficacious, and that there’s no substantial variability from patient to patient,” adding, “I don’t think any of that is true.”

        NPR (11/11, Harris) reports in its “Goats and Soda” blog that the meeting in Geneva will also consider how to design the trials to best meet ethical considerations and patient health. The WHO’s Martin Friede cautioned that placebo trials are met with skepticism in West Africa and notes other designs that can meet rigorous scientific challenges, saying, “This can be done through historical records, it can be through comparing what’s being done in other sites.” Friede added, “What we do not want are trials that are conducted where, at the end of the study, we are unable to say whether the drug is safe or not or whether the drug is effective or not.”

        OSU Scientist Develops Promising Ebola Treatment. The Oregonian (11/11, Terry) reports that a scientist at Oregon State University has developed a potential Ebola treatment. Patrick Iversen, the head scientist on the project, said initial trials were very promising, and that “If the epidemic lasts, I’m pretty sure we will use the drug (in Africa).” Sarepta Therapeutics, the firm behind this treatment, was in attendance at the NIH meeting on Tuesday. Sarepta has 20 courses of treatment available now and in two-three months, could have ten times that amount on hand.

Study: Experimental Hep C Treatment May Cure 97

LeadingNews

Study: Experimental Hep C Treatment May Cure 97% Of Liver Transplant Patients.

Bloomberg News (11/11, Chen) reports that in a “mid-stage study of 34 patients, 33 [97%] were cured of the virus after 24 weeks of treatment” using AbbVie Inc. (ABBV)’s hepatitis C treatment, an “experimental cocktail of ombitasvir, ritonavir, dasabuvir, ABT-450, and ribavirin, an antiviral drug used to supplement hepatitis C treatments.” The study, published today in the New England Journal of Medicine, involved patients “who had received a liver transplant.”

        Reuters (11/11, Penumudi) reported that in a study involving genotype 4 hepatitis C patients, the treatment was effective 100% of the time.

        Gilead: Hepatitis C Combination Treatment Cures 96-97% Of Cirrhosis Patients. Reuters (11/12, Pierson) reports that Gilead Sciences Inc. announced that its new combination hepatitis C drug Harvoni (ledipasvir/sofosbuvir), which was approved by the US FDA last month, cured 96-97% of cirrhosis patients with the genotype 1 of the virus who had failed to benefit from other treatments. In one subset of the 155 patients involved in the study, the patients took Harvoni alone for 24 weeks and were cured at a rate of 97%. In a group of patients who received Harvoni plus ribavirin for 12 weeks, the cure rate was 96%.

Facebook CEO Joins the Fight Against Ebola

Hear him:
I want to make sure Facebook does its part to help fight Ebola. So today, we’re announcing three things:

-We’re providing internet connectivity in Guinea, Liberia and Sierra Leone to help medical and aid workers track cases and coordinate their response.

-We’re sharing information on Facebook, in partnership with UNICEF, to help people in the affected and nearby countries prevent, detect and treat Ebola.

-We’ll soon be highlighting the work of some of the non-profits leading the fight on the ground, and giving everyone on Facebook the ability to donate directly.

Stopping Ebola is an important global challenge, and together we can make a difference. This video outlines our efforts. https://www.facebook.com/groups/696383700406188/864553410255882/?ref=notif&notif_t=like

Ebola Therapies In The Works.

According to Bloomberg News (11/4, Skerritt), Tekmira Pharmaceutical Corp.’s stock prices are the highest among makers of Ebola therapies. According to an October 21 statement from the company, the treatment is specific to Guinea’s Ebola strain and will “rapidly and accurately match the evolving genetic sequences” of the disease. In September, the FDA approved this treatment for confirmed Ebola patients. Bloomberg profiles other promising Ebola drugs, including their companies’ stock values.

        Bloomberg News (11/4, Bennett) reports that the board of GAVI, an organization of governments and the Bill & Melinda Gates Foundation that supplies vaccines to developing countries, will meet next month to decide which of the promising Ebola vaccines to support. GlaxoSmithKline’s vaccine is a contender for that support. The vaccine works to prevent Ebola in animals, but human trial results expected in December will reveal the drug’s true efficacy.

        The New York Times (11/5, Pollack, Subscription Publication) reports that studies for an Ebola quick-test are also underway. Rapid tests would be useful in West Africa, where lab results often take days, in airport screenings, and in hospitals amid the dawning flu season. The WHO and the FDA both support development of a rapid test.