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The Blog of Drug Discovery News

Did President Reagan suffer from Alzheimer’s disease while in office?

ddn has written countless stories about drug discovery and research efforts in the critical area of Alzheimer’s disease, and one area that researchers, clinics and drug manufacturers seem to be focusing on lately is pinpointing the onset of the debilitating disease. For example, in October, we reported on efforts by the Alzheimer’s Prevention Initiative (API) to test potential Alzheimer’s treatments and identify new biomarkers that could lead to earlier and more accurate diagnoses for Alzheimer’s patients. Researchers at the API told us that although there are many promising treatments being studied in Alzheimer’s symptomatic patients, by the time most people begin to show symptoms of the disease, it has already ravaged the brain, rendering these treatments ineffective.

This cold, hard reality has been making headlines lately with the release of a new book, “My Father at 100: A Memoir,” a close-up account of the life of President Ronald Reagan as seen through the eyes of his son, Ron Reagan. The book, which came out a few weeks shy of what would have been the former president’s 100th birthday on Feb. 6, is “an exploration of his character,” Ron Reagan says, but addresses the ongoing question of whether his father suffered with Alzheimer’s while in office.

President Reagan was diagnosed with Alzheimer’s in August 1994 at the age of 83, and he informed the nation about his diagnosis in a handwritten letter later that year. Although President Reagan’s White House doctors said they saw no evidence of Alzheimer’s while he was president, there was during his time in office widespread speculation that he demonstrated symptoms of mental degeneration. For example, former CBS White House correspondent Lesley Stahl wrote in her own memoir that at her final meeting with President Reagan in 1986, “Reagan didn’t seem to know who I was.” The president regained his alertness at the end of the meeting, Stahl wrote, adding, “I had come that close to reporting that Reagan was senile.”

Ron Reagan writes that that he noticed evidence of dementia as early as President Reagan’s first term. “I felt the first shivers of concern” during the 1984 reelection campaign, he writes, “that something beyond mellowing was affecting my father. My heart sank as he floundered his way through his responses. He looked tired and bewildered.” By 1986, President Reagan “had been alarmed to discover, while flying over the familiar canyons north of Los Angeles, that he could no longer summon their names,” his son writes.

Still, as he hits the press junket, Ron Reagan is careful to say that we cannot know for certain whether President Reagan exhibited signs of Alzheimer’s during his presidency. He also asserts that he believes if Reagan had gotten the diagnosis during his two terms, he would have stepped down.

In this video with TV personality Joy Behar, Ron Reagan clarifies his characterization of his father’s illness in his book.

“One can deduce that the disease must have been present, but I say specifically that I saw no dementia-like signs when he was in office,” he tells Behar. “Let’s recall that this was the oldest president ever elected (President Reagan was in his 70s). By the time he’s reaching his mid-70s, he’s losing his hearing, he’s been shot and nearly killed—which will take a little of the wind out of your sails—and of course I am worried about him all the time, because it’s a very tough job with a lot of stress. Every once in a while I would see—almost like when you are watching television, and it momentarily goes out of focus and snaps back. You think, ‘what did I just see?’ But I didn’t know what it was, I just knew I was concerned about him for all sorts of reasons. In retrospect, it’s possible that some of those early things were signs of Alzheimer’s, but I don’t know, and I can’t really make that claim.”

Some of the controversy, Ron Reagan tells Behar, may stem from “the confusion between Alzheimer’s the disease and dementia, which is a symptom of the disease—which usually arrives in the later stages.”

“Knowing what we know now about Alzheimer’s, that it’s a process that extends for years or even decades before symptoms arise, it’s kind of an academic question as to whether the disease was present when my father had” the debilitating disease, Ron Reagan says in this interview.

I think many of the researchers who read our publication would agree. What do you all think of Ron Reagan’s assertions? How does this “academic question” impact efforts to treat, manage or even reverse damage caused by Alzheimer’s?

January 27, 2011 Posted by | Academia & Non-Profit, Corporate, Labwork & Science | , , , , , , , , , | Leave a comment

For stem cell case plaintiff, faith and science go hand-in-hand

Yesterday, we shared a Q&A with the lead plaintiffs in the controversial federal lawsuit challenging federal funding for embryonic stem cell (eSC) research, Dr. James L. Sherley, a biological engineer at Boston Biomedical Research Institute, and Dr. Theresa Deisher, research and development director at AVM Biotechnology LLC in Seattle.

Both researchers agreed to field questions about their beliefs regarding eSC research. Deisher, who has been especially vocal about her Catholic faith and how it informs her research, also agreed to take a few questions about the connection she sees between her beliefs and science.

According to Deisher’s bio, she has 17 years of experience in scientific and corporate leadership positions involving research, discovery, production and commercialization of human therapeutics. She obtained her Ph.D. in molecular and cellular physiology from Stanford University. Prior to founding AVM Biotechnology in 2007, Deisher held positions at Repligen Corp. in Cambridge, Mass., ZymoGenetics Inc., Immunex and Amgen in Seattle and CellCyte Genetics Corp. in Bellevue, Wash. She has had 23 patents issued and has published numerous scientific manuscripts.

ddn: Do you find any conflict between your faith and the scientific research you engage in?

Deisher: I do not find any conflict between my faith, which is Catholic, and my research. My faith enhances my work. My Christian faith calls me to focus on drugs and treatments that are affordable so that the greatest number of people will benefit. My faith calls me to use reason and the order of natural law to determine, for instance, the stem cell most optimal for clinical use. My faith calls me to focus only on those treatments that will be effective. My faith also calls me to respect the intrinsic dignity of human life in my work.

ddn: How does your faith impact your research approach?

Deisher: My faith is completely complementary to my research, which focuses currently on stem cells for regenerative medicine and alternative vaccines.

Adult “self” stem cells, meaning a patient’s own stem cells, are affordable, compared to all other stem cell therapies. For the most part, therapies using adult stem cells will cost about $25,000 compared to Geron’s projected $500,000 for embryonic stem cell-based therapies. Adult “self” stem cells are found naturally in every organ, in each of us, and they are “preprogrammed’” to perform the functional regeneration that patients require. They also lack the issues of immune rejection or tumor formation that plague pluripotent stem cells such as embryonic stem cells. Adult “self” stem cells are far advanced in clinical trials, and in comparison to “patented” stem cell lines, they show more effectiveness in patients. Whether one believes in God or Darwin, one can arrive at an optimal stem cell for patients using objective measures, common sense and business criteria to generate the greatest good for the most people.

I would apply these same criteria to any type of treatment that I would work on, including biologics and small molecules: Will the therapy be affordable, or will only the very few benefit? Will the therapy be effective or merely enhance my stock price or financing temporarily? Will the therapy be undermined by adverse side effects? These criteria are sound business objectives and compatible with my faith.

November 11, 2010 Posted by | Academia & Non-Profit, Corporate, Government, Labwork & Science, Uncategorized | , , , , , , , , , , , , | Leave a comment

Alzheimer’s prevention: A call to arms

As our managing editor, Jeffrey Bouley, discussed last week, in our November issue we detail one group’s effort to develop to “launch the era of Alzheimer’s disease prevention research”—before another generation of patients is lost (see “An ounce of prevention”).

That effort, the Alzheimer’s Prevention Initiative, is a project launched by the Banner Alzheimer’s Institute, a nonprofit, collaborative research center in Phoenix.

Led by reknowned Alzheimer’s researchers Drs. Eric Reiman and Pierre Tariot, the API aims to test potential Alzheimer’s treatments and identify new biomarkers that could lead to earlier and more accurate diagnoses for Alzheimer’s patients.

Reiman and Tariot have been carrying the torch for Alzheimer’s disease prevention for many years. In the course of reporting on their work, Reiman shared with me an article they penned this year with colleague Jessica Langbaum that they consider “a call to arms.” The article, “Alzheimer’s Prevention Initiative: a proposal to evaluate presymptomatic treatments as quickly as possible,” was published in the Future Medicine journal, Biomarkers in Medicine.

The article contends that the evaluation of presymptomatic Alzheimer’s treatments must become an urgent priority, identifies what is holding us back and proposes new public policies and scientific strategies to overcome these roadblocks.

Here’s an excerpt from the piece:

“Alzheimer’s disease (AD) is an unacceptable problem. It takes a catastrophic toll on patients and family caregivers, and it is projected to have a financially overwhelming effect around the world in our children’s lifetime. In our opinion, the greatest roadblock in the scientific fight against AD is not necessarily the discovery of new treatments, but the means to evaluate them presymptomatically, when they may have their greatest impact, in a sufficiently rapid and rigorous way. It currently takes too many cognitively normal research subjects, too many years and too much money to evaluate more than a few presymptomatic AD treatments using clinical end points. Brain imaging and other biomarkers of AD progression and pathology have the potential to accelerate the evaluation of presymptomatic AD treatments. However, regulatory agencies are unlikely to provide accelerated approval for a presymptomatic AD treatment based solely on biomarker end points, without additional evidence from randomized clinical trials (RCTs) to conclude that a treatment’s biomarker effects are reasonably likely to predict a clinical benefit. In the meantime, sponsors are reluctant to conduct presymptomatic AD trials without a regulatory approval pathway. This dilemma may at first seem like an insurmountable ‘catch-22,’ leading to a sense of nihilism and a lack of urgency, but inaction is not an option.”

The article makes a compelling case for a sea change in the way scientists, researchers and pharmaceutical companies approach treating this devastating disease. To view the entire piece, please click here to download this PDF file: Reiman.

October 21, 2010 Posted by | Academia & Non-Profit | , , , | 1 Comment

Eye of the beholder

There are good drugs, there are bad drugs and there are questionable drugs.

But except in cases where a drug is clearly harming people (like, say, making them drop dead of heart attacks in droves), the value of a drug is a matter of perspective. Some argue that we overmedicate people, particularly in the Western nations, and others say we need to have more pills for everything. One person’s passion for developing a drug for an orphan disease is another person’s idea of a waste of money.

In any case, on this fall Friday, let the following image remind you that sometimes, it’s all a matter of perspective:

Have a good weekend, everyone.

October 1, 2010 Posted by | Uncategorized | , , , | Leave a comment

Market may be shrinking, but there are opportunities not to be sneezed at

According to global business information and analysis firm Datamonitor, generic erosion is set to shrink the allergic rhinitis market, and the firm predicts a 20% decline in sales value over the next 10 years despite a marginal increase in sales volume.

Datamonitor estimates that there are approximately 181 million people living with allergic rhinitis in the seven major markets, driving disease-specific drug sales of approximately $5 billion in 2009. This is set to drop to $4 billion in 2019 as a result of the entrance of generics following patent expiries, most notably in the United States.

However, despite the forecast drop in sales in the allergic rhinitis market, Datamonitor has identified potential growth areas, most notably in the immunotherapy segment of the market. Furthermore, life cycle management strategies have been identified that may help to lessen the impact of patent expiry of symptomatic treatments.

“Immunotherapy is the only treatment option for allergic rhinitis with a disease modifying potential, but concerns over cost and safety, particularly for subcutaneous formulations, have kept symptomatic treatments as the more popular choice,” notes Jacoba van der Gaag, healthcare analyst at Datamonitor. “However, in recent years we’ve been witnessing large-scale development programs in immunotherapy for the first time, driven largely by new guidelines and changing regulations. This will always be a niche market, though this innovation is now promising growth.”

For example, Datamonitor forecasts that two new sublingual tablets targeting grass allergies, Grazax (ALK-Abelló) and Oralair (Stallergènes), will have combined sales of $264 million in the United States and European Union by 2019. The potential for growth in this market is reflected by the pipeline for allergic rhinitis, which is dominated by immunotherapies targeting multiple types of allergen.

Another opportunity exists within the antihistamine class, where life cycle management strategies are used to lessen the impact of generic erosion. An established strategy amongst key brands is the reformulation of molecules and/or combinations with decongestants. This strategy helps to reduce the loss to franchise sales and strengthen brand recognition following patent expiry of the primary molecule.

Jacoba concludes: “The success of this strategy relies heavily on timing of new launches relative to generic entry. Merck’s Clarinex (desloratadine) suffered as a result of launching after its predecessor Claritin’s (loratadine) patent expired, which was demonstrated by it reaching only a quarter of Claritin’s peak sales in 2009. Meda Pharma, on the other hand, has seen successful patient switching from once to twice-daily azelastine having launched prior to patent expiry, and is developing an azelastine/fluticasone combination that is expected to further strengthen its franchise.”

September 29, 2010 Posted by | Corporate | , , , | Leave a comment