Alzheimer’s Disease could be reversed by rheumatoid arthritis protein

SRxA’s Word on Health is encouraged to learn that scientists have discovered that a chemical normally produced by the body to fight arthritis, could also reverse the memory loss associated with Alzheimer’s Disease.

Although it’s already known that people with rheumatoid arthritis, have a reduced risk of Alzheimer’s, until recently, most experts assumed this was due to the anti-inflammatory drugs given to treat the disease.

Now, researchers at the University of South Florida have found that a protein, triggered by rheumatoid arthritis, can undo the ‘tangles‘ in the brain that are thought to cause Alzheimer’s.

While people with rheumatoid arthritis are subjected to swollen joints and decreased mobility, the protein produced by the disease stimulates scavenger cells in the body.

The new study, published online in the Journal of Alzheimer’s Disease, found that the protein, GM-CSF, could both reverse the memory loss associated with Alzheimer’s and lower the risk of getting the illness.  In some cases the memory impairment was completely undone after treatment.

The placebo-controlled tests in mice, showed that those treated with GM-CSF had >50% decrease in beta amyloid, the hallmark substance of Alzheimer’s disease. They also showed more microglia – specialized immune cells which remove toxic substances, in the treated animals. In contrast Alzheimer’s mice injected with the placebo salt solution continued to do badly in the tests.

We were pretty amazed that the treatment completely reversed cognitive impairment in 20 days,” said Dr Tim Boyd, the scientist who led the study.

What makes these results especially noteworthy is that the protein is not experimental.  A synthetic form of this naturally occurring protein is already commercially available under the brand name Leukine (sargramostim).  Leukine is a recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) manufactured by Genzyme.  While not indicated for use in Alzheimer’s, it has been approved by the FDA to reduce the incidence of severe and life-threatening infections in some chemotherapy patients with acute myelogenous leukemia (AML). Leukine is also used in multiple stem cell transplantation settings.

Our study, along with the drugs track record for safety, suggests Leukine should be tested in humans as a potential treatment for Alzheimer’s disease” commented Prof Huntingdon Potter, a molecular medicine expert involved in the study.

While we recognize that rarely a day goes by without news of some new “breakthrough” for the estimated 35 million people worldwide who suffer from Alzheimer’s disease, your Word on Health team hopes that this latest research brings the promise of a cure or treatment even closer.

FOUND! The Holy Grail of Weight Loss?

An appetite-control agent that requires no prescription, has virtually no side effects, and costs almost nothing? Have our prayers finally been answered?

So what is this magical elixir?

According to the results of a new clinical trial unveiled at the 240th National Meeting of the American Chemical Society (ACS), the answer is… water.  Just two 8-ounce glasses of the stuff, taken before meals, enables people to shed pounds say researchers.

Brenda Davy Ph.D., senior author of the study said, “We are presenting results of the first randomized controlled intervention trial demonstrating that increased water consumption is an effective weight loss strategy. Over the course of 12 weeks, dieters who drank water before meals, three times per day, lost about 5 pounds more than dieters who did not increase their water intake.”

Although folklore and everyday experience have long suggested that water can help promote weight loss, there has been surprisingly little scientific information on the topic. Previous studies have hinted that drinking water before meals reduces intake of calories, but until now, there has been no “gold-standard” evidence.

This randomized, controlled trial included 48 adults aged 55-75 years and compared weight loss among dieters who drink water before meals with those who do not.

One group drank 2 cups of water prior to their meals and the other did not. All of the subjects ate a low-calorie diet during the study. Over the course of 12 weeks, water drinkers lost about 15.5 pounds, while the non-water drinkers lost about 11 pounds.

Exciting stuff.  But, before you go draining the faucet in an attempt to shed even more pounds, SRxA’s Word on Health cautions its readers about a rare, but potentially fatal condition known as water intoxication.   So how much water should you drink? The Institute of Medicine says that most healthy people can simply let thirst be their guide. It does not specify exact requirements for water, but sets general recommendations for women at about 9 cups of fluids a day, and men at about 13 cups of fluids.

See you at the water cooler?!?

More Guidelines on Pharma – Physician relationships

A recent report issued by the Association of American Medical Colleges (AAMC) urges teaching hospitals to establish policies to manage financial relationships between physicians and the pharmaceutical industry so that they do not influence patient care.

The report entitled, In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making is the work of a task force convened by the AAMC in 2009.  It provides guidance on how academic medical centers can identify, evaluate and disclose conflicts of interest in clinical care. In its favor, the report points out that partnerships between academic medical centers and industry are essential to innovation and create powerful collaborations that benefit all patients. However, it warns that the presence of individual or institutional financial interests in these relationships may create perceived or real conflicts of interests in patient care.

Because patients and the health of the public are top priorities for the nation’s medical schools and teaching hospitals, we must uphold the highest standards of professionalism, while maintaining principled relationships with industry to improve patient care,” said AAMC Chief Health Care Officer Joanne M. Conroy, M.D.

Although many academic medical centers already have conflict of interest (COI) policies that govern research and corporate relationships, only a small number of these institutions have adopted policies that define and address conflicts of interest in clinical care.

To help academic medical centers develop guidelines, the report suggests that institutions first evaluate their own compensation systems to determine whether they influence physician behavior and conflict with the best interest of patients.

The report also recommends that academic medical centers:

  • Establish mechanisms to identify physician-industry financial relationships and evaluate their potential to bias the clinical decision-making of physicians
  • Consider payments for services, royalties, and ownership when assessing individual related financial interests
  • Set thresholds for physician reporting and institutions’ evaluation of reported interests
  • Make available to their patient communities and the public information on the industry relationships of their physicians, their value, and efforts to mitigate any bias resulting from these relationships
  • Involve patients to help them to determine what information about physician-industry ties is useful and how it should be presented to specific patient groups

As a follow up to the report, the AAMC is developing clinical scenarios that can be used by its members to help define their approach to addressing conflicts of interest in patient care.

SRxA’s Word on Health welcomes these guidelines and is pleased to see that we are now talking about “managing relationships” with the pharmaceutical industry rather than banning them altogether.  Placing the onus on physicians rather than putting punitive prohibitions on pharma is probably a win-win for both sides.

Did Lou Gehrig have Lou Gehrig’s Disease?

Ridiculous question?  Or perhaps not, according to new data published this week in the Journal of Neuropathology & Experimental Neurology.

The study, involving 36 subjects, suggests that some patients may be misdiagnosed with amyotrophic lateral sclerosis (ALS) a form of motor neuron disease also known as Lou Gehrig’s disease.  Instead they may have a newly characterized disease called chronic traumatic encephalopathy (CTE).  CTE, a central nervous system disease, is thought to occur as a result of repeated concussion-like trauma.

TDP-43

The researchers used sophisticated neuropathology techniques to study the proteins – tau and TDP-43, in brains obtained at autopsy from twelve former athletes. Eleven of the athletes had been professional football players or boxers; one was a hockey player.

All of the athletes had CTE, with dementia developing many years after a history of repeated concussions. Three of the athletes were also affected by fatal motor neuron disease, with profound and progressive muscle weakness and deterioration for several years before death. The brains from patients with CTE and motor neuron disease showed specific patterns of tau and TDP-43 deposits, distinct from those of sporadic ALS.

Of course, most people who develop ALS are not pro athletes. “The study has broad implications, not only for understanding the potential risks to professional and non-professional athletes in many types of collision sports, but also for people who serve in military combat,” said Dr. Raymond A. Sobel, Editor-in-Chief of Journal of Neuropathology & Experimental Neurology. “Anyone who experiences repetitive, seemingly mild, head injury or concussion might be at risk for developing a brain disease later in life.”

However, some critical research questions remain. It’s still unknown exactly how brain injury leads to protein deposits, or whether head trauma produces these changes alone or in association with certain genetic factors.

What is known and clearly documented is that Lou Gehrig suffered significant concussions playing baseball and was notorious for playing through such injuries. Could he have been an early victim of CTE?

Sadly, Word on Health can’t answer this.  According to biographers his remains were cremated and thus cannot be studied.

Watch Out – the FDA’s About!

It’s been a busy year for the FDA.  In addition to approving 63 new and original drug applications (NDA’s and BLA’s)  since the beginning of 2010, the Agency has rejected countless more, including the much touted “pink pill” or Female Viagra and the fat fighting drug Qnexa.

They also appear to have taken on the pharmaceutical industry – in a big way.

Industry insiders and observers are all acutely aware of the increase in the number of Warning Letters and Notice of Violation letters coming out of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC).

Since January 2010, DDMAC has issued 71 warning letters, notifying pharmaceutical companies about promotional violations. The number has been steadily rising since 2009.

Word on Health suspects that this may, in part, be due to the fact that the FDA recently reversed a policy that required warning letters to undergo legal review before they were issued. Then again, maybe the Agency’s BadAd program is bringing more promotional “no-no’s” to their attention.

Others would like to blame social media and the lack of FDA guidance for the increase. Indeed, just last week the FDA issued a Notice of Violation letter regarding the “Share” function on Facebook.  It’s also rumored that DDMAC has staffed up.

Whatever the reason, it means the pharmaceutical industry needs to be more careful than ever.

SRxA can help companies develop and deliver, compliant and effect programs. Contact us today to learn how we can help you avoid becoming another FDA statistic.

The Risks And Rewards Of Inviting Patients To Review Their Medical Records

Technology has placed vast amounts of medical information literally a mouse click away. Indeed, 57% of Americans say they get their primary medical information from the internet.  Maybe that’s because, an individual’s main potential source of information, the doctor’s notes, taken after a visit are not traditionally part of the discussion. Such records have long been out of bounds.

After patient encounters, doctors have long written notes ranging, from cryptic abbreviations on an index card to lyrical essays. Yet despite a patient’s legal right to read their doctor’s note, few do. Although literature suggests that promoting active patient involvement in care may improve doctor-patient communication and clinical outcomes, both patients and doctors express everything from enthusiasm to dismay when it comes to sharing the visit note.

In Open Notes: Doctors and Patients Signing On,  researchers speculate about the risks and rewards of making clinicians’ notes transparent to patients.  “Opening documents that are often both highly personal and highly technical is anything but simple,” say the investigators from Beth Israel Deaconess Medical Center.

Their OpenNotes study will include more than 100 primary care doctors and 25,000 patients who will be invited to read their notes.  Some primary care doctors interviewed as part of a pre-study assessment “…anticipated both clinical benefits and efficiencies from incorporating laboratory findings and recommendations into the note, thereby obviating the need for a follow-up letter.” They hoped for improved patient education and more active involvement by patients in their care.

On the other hand, some doctors “worry first and foremost about the effect on their time, including calls, letters and e-mails as patients seek clarifications, disagree with statements, or correct what the doctors consider trivial errors of fact.”

Others were concerned they would have to leave out important information, omit frightening diagnostic or therapeutic considerations, or that patients would not understand that ‘SOB’ stood for ‘shortness of breath.’   And some were simply embarrassed about how they write!

From the patient perspective, views are also somewhat mixed.  For some of the patients, the dialogue inherent in the process was appealing.  On the other hand, some clearly do not want to read what their doctors write because they are worried about discovering something they would rather not know, finding potential diagnoses that might make them anxious, or reading what their doctors really thought of them.

The study will use secure Internet portals and only include notes written during the trial period. While they are gathering considerable data from the patient and doctors’ experiences during the study period, investigators say their ultimate question is whether the participants will want to leave the OpenNotes switch on after 12 months.

What do you think about sharing notes with your doctor or patients?  Word on Health is waiting to hear from you.

To know or not to know?

That’s a dilemma many of us may soon face.  Researchers announced this week that they have found that a test that can identify Alzheimer’s disease with almost 100% accuracy, long before symptoms emerge.  However, and here’s the rub, there is still no definitive treatment for the disease.

Although experts say the results of the study are promising, they caution that its practical implications are limited. “The reality is that many people are not going to want to do it,” predicts Lou-Ellen Barker, President of the NY chapter of the Alzheimer’s Association.

The Alzheimer’s test measures two proteins, beta-amyloid and tau, in cerebrospinal fluid (CSF), obtained by a lumbar puncture, or spinal tap.  During the procedure, a doctor inserts a needle into the spinal canal and removes a small amount of CSF which is then examined for evidence of abnormal development of beta-amyloid proteins, which form plaques, and tau proteins, which form tangles.   Both plaques and tangles are thought to contribute to the development of Alzheimer’s disease.

In similar work, scientists from the UK, announced that they had developed a blood test, based on the protein clusterin, that could detect Alzheimer’s Disease years before clinical symptoms.

Either way, early diagnosis would allow researchers to monitor the stages of the disease far more closely and ensure early intervention with medications that may slow the progression of the disease.  In addition, early detection would allow patients to make their voices heard and “get their affairs in order” before their minds slip.

Would you want to know?  Share your thoughts with Word on Health.

The end of swine flu?

Word on Health breathed a big sigh of relief earlier this week when the World Health Organization (WHO) declared the official end of the influenza A (H1N1) pandemic.

According to WHO the virus has largely run its course and we are now in the “post-pandemic period.” In other words, the virus is now expected to take on the behavior of the seasonal flu virus.

Does that mean we can expect to see few people wearing surgical masks in airplanes and on the Metro?  Will it be safe to leave our homes and desks without our bottles of hand sanitizer?

Can we revise our infectious disease presentations once again and consign H1N1 to the box of viruses of former concern, along with Ebola and SARS?

Was all the fuss worth it?

Responding to concerns that the agency acted too hastily in declaring a pandemic  last June, the WHO said it was “the right call.”  WHO Director-General Margaret Chan added that “we have been aided by pure good luck.” Chan noted,  if the virus had mutated then the current death toll of around 18 500 could have been much higher.

For those of you who can’t quite shake off the fear of H1N1, the good news is that the regular 2010 flu shot will contain protection against swine flu too.

A giant step for mankind?

SRxA’s Word on Health was excited to learn that the FDA has finally given the all-clear to test embryonic stem cells as a potential treatment for spinal cord injury.

Geron Corp. who has invested 15 years of research and over $150 million to develop the treatment, finally hopes to start human testing by year-end.   The stem cell therapy known as GRNOPC1 contains cells called oligodendrocyte progenitor cells. Those progenitor cells turn into oligodendrocytes, a type of cell that produces myelin, a coating that allows impulses to move along nerves. When those cells are lost due to injury, paralysis can follow. If GRNOPC1 works, the progenitor cells will produce new oligodendrocytes in the injured area of the patient’s spine, potentially allowing for new movement.

The therapy will be injected into the patient’s spine 1-2 weeks after the patients suffer an injury between their third and tenth thoracic vertebrae, or roughly the middle to upper back. The company plans to enroll 8-10 patients across the U.S.  Each patient will be studied for one year and monitored for a further 15 years. A successful outcome would lead to larger and longer studies of GRNOPC1. Later trials would include patients with less severe spinal injuries and damage to other parts of the spine

Doctors are euphoric. Professor Richard Fessler,  MD, a neurological surgeon at Northwestern University says it may be possible to completely restore a patient’s motor functions.    “It would be revolutionary. The therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year.”

While this study may come too late for many high profile campaigners, including “Superman” and a former first lady, it has the promise of being a step in the right direction.

In the words of Nancy Reagan, “Countless people suffering from many different diseases, stand to benefit from the answers stem cell research can provide. As I’ve said before, time is short and life is precious.”

Right or wrong?  Word on Health looks forward to hearing from you.

Asthma inhalers may be linked to increased risk of prostate cancer

Once again, asthma drugs are back in the spotlight.

According to a new study, several of the drugs used to treat asthma may increase the risk of prostate cancer.

The biggest danger appears to be among those with severe asthma who frequently need treatment with steroid tablets or injections.  Among this group, the risk of cancer increased by up to 70% say the researchers from Australia. But they are not alone.  Their data showed that men who regularly use inhaled steroids to keep their asthma under control are 40% more likely to develop a tumor than men without asthma; and those who regularly use a bronchodilator to relieve their wheezing are 36% more at risk of the disease.

Although the same research found having asthma itself appears to increase the risk by around 25%, the chances of a tumor were significantly higher in the men who were taking medication.

The researchers studied 1,179 men who had been diagnosed with prostate cancer and analyzed how many had a history of asthma. They chose to investigate a possible link between the two conditions because both involve an inflammation of the body.

While the results, published in the journal Cancer Epidemiology, Biomarkers and Prevention, raise concerns, Word on Health cautions that they need to be confirmed by much bigger studies, before reviewing or changing current asthma therapy guidelines.

Dr. Elaine Vickers, from Asthma UK agrees.  “We urge men with asthma not to stop taking medication on the basis of these results.”

As always, Word on Health welcomes your views on this.