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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?

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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

MIT is putting nature to work for pharma

All right, nature, get to work! You’re on academia’s clock now, and pharma’s in the future

That’s right, the Massachusetts Institute of Technology (MIT) in Cambridge, Mass., is appropriating some of Mother Nature’s children and putting them to work to produce drugs, finding ways to make at least one plant (periwinkle) and at least one microbe (E. coli) make oncology drugs, according to a pair of fall announcements.

The first announcement came in late September with word that MIT researchers and collaborators from Tufts University have now engineered E. coli bacteria to produce large quantities of a critical compound that is a precursor to the cancer drug Taxol, originally isolated from the bark of the Pacific yew tree. The tree’s bacteria can produce 1,000 times more of the precursor, known as taxadiene, than any other engineered microbial strain, and the new MIT technique could bring down the manufacturing costs of Taxol.

More than that, it could also help researchers discover potential new drugs for cancer and other diseases such as hypertension and Alzheimer’s, says Gregory Stephanopoulos, who led the team of MIT and Tufts researchers.

“If you can make Taxol a lot cheaper, that’s good, but what really gets people excited is the prospect of using our platform to discover other therapeutic compounds in an era of declining new pharmaceutical products and rapidly escalating costs for drug development,” says Stephanopoulos, the W.H. Dow Professor of Chemical Engineering at MIT.

Early November brought the second announcement, that researchers led by an MIT associate professor, Sarah O’Connor, have added bacterial genes to the periwinkle plant, enabling it to attach halogens such as chlorine or bromine to a class of compounds called alkaloids that the plant normally produces. Many alkaloids have pharmaceutical properties, and halogens, which are often added to antibiotics and other drugs, can make medicines more effective or last longer in the body, MIT reports.

The team’s primary target, an alkaloid called vinblastine, is commonly used to treat cancers such as Hodgkin’s lymphoma. O’Connor sees vinblastine and other drugs made by plants as scaffolds that she can modify in a variety of ways to enhance their effectiveness.

“We’re trying to use plant biosynthetic mechanisms to easily make a whole range of different iterations of natural products,” she says. “If you tweak the structure of natural products, very often you get different or improved biological and pharmacological activity.”

Although engineering new genes into plants is nothing new, O’Connor’s approach, known as metabolic engineering, goes beyond simply adding a gene that codes for a novel protein. As MIT described it, “Metabolic engineers tinker with the series of reactions that the host organisms use to build new molecules, adding genes for new enzymes that reshape these natural synthetic pathways. This can lead to a huge variety of end products.”

In future work, the researchers hope to engineer full periwinkle plants to produce the novel compounds. They are also working on improving the overall yield of the synthesis, which is about 15-fold lower than the plant’s yield of naturally occurring alkaloids.

With this much activity in two such disparate organisms, one can only imagine what MIT will put into service next. Maybe they can recruit some of those weeds in my garden to work for pharma so that they can do something more productive than rip my hands to shreds as I yank them up.

November 4, 2010 Posted by | Academia & Non-Profit, Labwork & Science | , , , | Leave a comment

Too many cooks at the cancer pot?

This may sound almost heretical from a guy who writes about pharma and biotech business deals and research for a living, but have we perhaps gotten to the point where there are too many organizations in the oncology arena, whether trying to market a product or find a breakthrough around which to build a product?

It’s almost physically uncomfortable for me to voice such a theory, given how pervasive cancer is as a worldwide threat to human life. After all, with such a huge killer of people, wouldn’t you want as many people as possible looking for as many ways as possible to thwart tumors from stealing away precious years and robbing people of quality of life even when they don’t actually lose their lives?

And yet I find myself thinking of the “green” and “organic” movements, and wonder if they are precursors to where oncology is going.

Think about it. The green movement was supposed to be about wise use of resources and a shift toward energy efficiency, reduction of waste, more recycling and the like. But now it seems like many companies want to label themselves as “green” because they use recycled paper coffee cups in the cafeteria or because they encourage carpooling (even though they’re emitting who-knows-what into the air from the business itself). It’s become a gimmick or label, instead of being a worthwhile goal in and of itself.

The organic movement, too, has been corrupted so as to be almost meaningless in many cases. The federal standards to be considered “organic” are too lax, and many big companies slap the word “organic” on unhealthy food items as a sales tool. Also, many foods are labeled as “natural” to suggest they are healthy. Well, lard is natural, but if I consume it straight from the package daily, I will likely need a quadruple bypass eventually.

I fear that oncology, which is justifiably one of the biggest areas of interest in pharma, biotech and diagnostic research, is heading down a similar path.

These concepts began to swirl in my brain a bit some months back when I was interviewing a source for an article dealing with gene-based therapies. He had made an offhand comment about how so many companies were entering the ‘omics space in general—from genomics to proteomics to metabolomics and beyond—that he wondered if there were too many companies trying to jump onto the bandwagon, and he added, “much like we’ve seen with oncology.” He pondered whether they were all there for the sake of the science or if many of them were there to simply make money on the next hot thing. He worried that the cacophony and clutter of too many cooks in the ‘omics kitchen might spoil the broth. And in his mind, he had already seen that happen with oncology.

The thoughts began to come to a full boil when I was doing research for my “Foursome aims to be outsourcing force” article for the October 2010 issue of ddn, and I noticed this tidbit in another article about the merger of Averion International, Trio Clinical Research, Fulcrum Pharma and Clin-Research/ADDPLAN into one global biopharmaceutical and medical device development services organization:

While both Averion and Fulcrum Pharma share a specialty in oncology studies, Donnelly said the company’s focus will be more about bringing new processes and techniques to drug development rather than touting therapeutic expertise in specific areas. “Everybody out there is saying, ‘We are the oncology CRO.’ It’s the largest market out there, so everyone wants to be that. But we want to take that knowledge to the next generation as far as being able to do adaptive trials with it. That’s a differentiator,” he said.

Imagine that. Companies that were known for their oncology expertise, but the field is so crowded that to stand out, they downplay their oncology focus a bit.

It suggests that perhaps things have gotten too crowded.

It’s not that I begrudge anyone making money off of an oncology discovery or product. Far from it. Also, I appreciate the many new strategies and innovations that are helping to provide more hope for people who have been touched by cancer or who fear they might be.

But what I really want to see in the field are academic institutions, companies and other entities who are passionate about beating cancer.

What I fear, though, is that perhaps some are in it just for the money or prestige. They want to be the one who comes up with the next big idea or gets rich from it, and might be willing to put something other than their hearts and minds into the process to make sure that happens. They might be willing to rush, or cut corners, or overlook simpler and cheaper solutions.

It’s not likely a huge problem yet. But I wonder if it will become one. I would hate to see cancer become merely a market opportunity or a fad. I want organizations and the researchers within them to want to beat cancer, because I feel that’s the motivator that will truly lead to cures.

October 13, 2010 Posted by | Academia & Non-Profit, Corporate, Labwork & Science | , , , , , , , | Leave a comment

CROh-my-goodness!

Well, it looks like Christmas came early for Covance, landing a $2.2 billion deal with sanofi-aventis (more on that here). I don’t think I’m anywhere near alone when I say, “Didn’t see that one coming!”

Whether this is a sign of much larger things to come in terms of the contract research space and continued pharma and biotech outsourcing, only time will tell. But I’m guessing we’ll see more deals and even bigger dollar amounts before long.

By the way, maybe it’s me just showing my age (42, for the record), but I still have trouble wrapping my mind around multibillion-dollar collaborations. Buying a whole company for billions…well, I’ve gotten used to that, and understand it totally. But the world is moving fast, because I don’t recall too many deals (aside from acquisitions) going into the billions-and-billions of dollars territory until pretty recently.

Anyway, more details on, and insights into, the Covance/sanofi-aventis deal from us in the weeks to come.

September 30, 2010 Posted by | Corporate, Dealmakers | , , , , , | Leave a comment