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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

Good news, bad news

As is so often the case, I greet stories of mergers with a sense of “yes, a company successful enough to be bought out by (or combine with) someone larger…congrats to them!” that is mixed with the “oh crap, more people are going to be jobless now, probably” feeling.

Case in point: Valeant Pharmaceuticals in California is laying off 500 people subsequent to the fall merger deal with the former Biovail, which had been Canada’s largest publicly traded pharma company…

Read more (and try not to weep; at least it isn’t the thousands upon thousands that so many Big Pharmas have announced are getting the axe in recent months, as ddn Chief Editor Amy Swinderman talked about here and here.)

January 14, 2011 Posted by | Corporate, M&A activity | , , , , , | Leave a comment

The paradox of pain

The global market for pain-relieving drugs has either been approaching or surpassing the $50 billion as we’ve moved from around 2007 to the present day. It’s clearly a huge market, and especially attractive given the numbers of people who suffer from neuralgia, fibromyalgia and lower back pain.

I wrote recently about Pfizer extended its offer to acquire King Pharmaceuticals, largely out of a desire to get access to the latter company’s abuse-resistant pain medications.

And there we go with the crux of things: Abuse potential.

Bad enough that the pharma and biotech companies have to deal with ADME-Tox issues that can kill their drugs before reaching market (but no before eating up hundreds of millions in R&D costs), but now one of the more attractive markets is one in which some of the best pain-relieving drugs are potentially addictive. The question is: How many of the most promising experimental drugs in the pipeline now will be able to deal with the abuse and addiction issue while also answering patients’ needs for relief from their suffering.

This question weighs on my mind as I read a recent article from the Harvard Mental Health Letter:

Painkillers fuel growth in drug addiction, from the Harvard Mental Health Letter

BOSTON—Prescription painkillers kill about twice as many people as cocaine and five times as many as heroin. Nearly two million Americans are dependent on or abusing narcotic (opioid) pain relievers—nearly twice as many as are addicted to cocaine. Because opioid painkillers target the same brain receptors as heroin, causing euphoria, they carry the risk of addiction.

On television shows, drug addicts are often depicted as criminal characters making deals on dark street corners. In fact, people abusing opioid painkillers are most likely to obtain them from friends or family members rather than from any other source, reports the January 2011 issue of the Harvard Mental Health Letter.

Dr. Michael Miller, editor in chief of the Harvard Mental Health Letter, explains that treatment for a painkiller addiction is most successful when it consists of two phases: detoxification to reduce or eliminate withdrawal symptoms after opioid use stops, followed by a longer (and sometimes indefinite) maintenance phase. Although counseling is an important part of treatment, most people addicted to painkillers require treatment a medication such as methadone or buprenorphine during both detoxification and maintenance therapy. Although most people addicted to opioids make multiple attempts to kick the habit, it can be done.

This is a tricky situation, and as with so many things in my coverage of the pharmaceutical business realm, I find myself of multiple minds on the issue.

  • Are pharmas too eager to tap into this market, even though many of the best pain relievers lead to addiction and abuse in far too many people?
  • Are people themselves simply too eager to want a “magic pill” for everything rather than, as we might have been told once upon a time, “working through the pain”?
  • Am I overthinking this issue?

I’m not a person who wants to see suffering, so it is troubling that on the one hand, people might have to deal with pain while on the other hand, they might trade in agony for addicition.

It’s quite the quandary, as well as the paradox of pain: In helping people, pharmas may be hurting them as well.

On the bright side, though, pharmas like Pfizer are increasingly attracted to products that will reduced potential for abuse while still providing relief. Certainly, that is a potential profitable combination for them, and I wish them well.

But I continue to wonder how soon we’ll get to that point, and how many people will face this paradox of pain (and and for how many years) until we get there.

January 10, 2011 Posted by | Academia & Non-Profit, Corporate | , , , , , , | Leave a comment

Hoarders: Pharma edition

I can only hope my wife won’t kill me for letting this information out to all of you, but she has some guilty pleasures in terms of television. She doesn’t watch a whole lot of it, but she does have a thing for “General Hospital” when she doesn’t have to be at the office between 3 and 4, and she watches a few reality shows regularly or semi-regularly, such as “Real Housewives of Atlanta.”

But what’s appropriate for my purposes in this post is to mention her love of the show “Hoarders.” OK, love might be too strong a word. It’s more of a love/hate thing, and she watches it almost out of a compulsive fascination, much like the human inability to avoid looking over at a car accident, train wreck, lover’s spat or your spouse’s e-mail inbox…just to see if it’s as bad as you think.

For those of you not familiar, each episode follows the efforts of a clean-up crew and mental health professionals to deal with two different homes in which compulsive hoarding of items, garbage, animals or whatever else has reached crisis proportions. Some episodes require a strong stomach, as you can almost smell the putrid fumes through the television screen.

I wonder how many pharma and biotech companies, particularly the big ones, are about to need some facemasks to deal with some bad smells that could soon be coming out of their servers, computers, databases or what-have-you.

No, I’m not talking about the hardware overheating; I’m talking about data.

As we prepare in the January issue of ddn to delve into a special report series on screening technologies, I find myself wondering if the drug discovery and development world has become a collective mass of hoarders when it comes to data.

I don’t mean that they keep things to themselves to protect their intellectual property. That’s totally understandable. What I mean is that I fear they may have too much data. Don’t misunderstand me, though. I’m not a Luddite. I adore the wonders of next-gen sequencing and computers that can hold terabytes upon terabytes of data. I love that we can sequence genomes and dig deep.

But the truth is that we don’t know what to do with this data in many cases. Companies have it, but they don’t yet know what to look for to make it work for them most effectively. All these massive amounts of data can yield up wondrous gems in the near-term in some cases, but much of it is simply hoarded ones and zeroes on storage devices, waiting for us to catch up with it. Waiting for us to gain enough understanding of genomics, proteomics, metabolomics, biomechanics and so much more so that we know what all the data we have at our fingertips now actually means.

I mostly have faith that all that data will not be a wasted effort and that we will indeed put it to good use. On the other hand, how much of it is totally unnecessary and useless? Worse yet, since we’re already acquiring data far, far, far faster than we can figure out what to do with it, what if that trend continues? What if we gather data at a geometric rate, while our ability to manage it continues at something more like a linear rate?

What are we going to do with all the data? And how much good stuff will we lose in the mess we create?

And will we need a new reality show called “Biotech Hoarders” to run on TLC or the Discovery Channel?

January 4, 2011 Posted by | Corporate, Labwork & Science | , , , , | Leave a comment

Who? What? How much?

So, as I was writing a news article (here) on the web site about Axcan Holdings getting prepped to buy out Eurand N.V., I was struck with an overwhelming question.

Who are these companies?

I don’t mean to be flip, mind you. They’re both legit pharma entities, with Axcan having a strong gastrointestinal focus and Eurand having six FDA-approved products under its belt. But I’ve never heard of either one of them.

This isn’t odd, of course. There are so many small and mid-size pharmas and biotechs that even the most hardened life sciences market analyst couldn’t know them all. No matter how much we are in the business or reporting about it, there will always be company names that make us say, “Never heard of ’em.”

But the reason this sticks out for me is that the buyout deal is for $583 million. That’s over a half-billion dollars.

Isn’t that a lot of money? Shouldn’t I have heard of these companies in passing before, with that kind of money about to change hands?

Or is it just that things have begun to move so quickly now, and so much money is being thrown around the world economy that a billion dollars is “the new black?” That is, being a millionaire now, even at the high ends, is perhaps passé, and now you don’t matter as a rich person unless you break the billion mark?

I realize that as I get older, I will look back at the “good old days” (or bad old ones, for that matter) and say, “What happened?” I already do, and I recognize it.

But still, half a billion dollars seems to me like the kind of money that gets thrown around by pharmas I’ve heard of before. It just doesn’t seem like in the mere five-and-a-half years that I’ve been on staff at ddn that we could have gone from half a billion being big news to simply being a blip on the radar.

So, I wonder: Is the fault in me that I’ve never heard of these companies before and should have? Or just that the world is moving so fast now that it’s hard to keep up with the dollars and the deals?

December 2, 2010 Posted by | Corporate, Dealmakers, M&A activity | , , , , , , | Leave a comment

More pink slips

Well, the topic is not a new one, and ddn Chief Editor Amy Swinderman did a bang-up job talking about the pharma layoff issue a month-and-a-half ago (click here), but it’s starting to feel like we’re gearing up for another round of these things.

Just over a week ago I posted a story about Roche restructuring/layoff plans (at our web site), and now this:

__________________________________________

Novartis Pharmaceuticals Corp. to cut 1,400 U.S. jobs

EAST HANOVER, N.J.—Novartis Pharmaceuticals Corp. announced Nov. 30 that it is restructuring its General Medicines field force in the United States to reflect changes in the product portfolio and align resources with strategic growth priorities. The company will reduce its General Medicines field force by approximately 1,400 positions. These changes will be effective Jan. 1, 2011.

The product portfolio within the Novartis General Medicines business is changing due to pending patent expirations and pipeline products. There are new product launches expected within the Primary Care business and significant growth momentum within the Specialty Care business that will drive long-term success. Given these changing dynamics within the portfolio, it is critical to realign the General Medicines field force to sharpen focus on the greatest opportunities for growth. The restructuring is expected to result in a one-time cost of approximately $85 million.

“NPC has a robust pipeline and the future growth potential for our organization remains strong. Proactively evolving our business model will enable us to focus our resources on key launch products and capture opportunities in both primary care and specialty medicines,” said Andy Wyss, head of Novartis Pharma North America and president of Novartis Pharmaceuticals Corp.

All reductions will, according to the company, be handled in “a manner consistent with the Novartis commitment to fair and respectful treatment of associates. Outplacement and other support services will be available to impacted associates as well as redeployment opportunities, where they exist, within the Novartis Group of companies.”

__________________________________________

Keep those résumés updated, everyone…

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December 1, 2010 Posted by | Corporate | , , , , | Leave a comment

Social butterflies

Corporations are sometimes a bit slow to pick up on technological trends, particularly when it comes to information technology. They might be somewhat behind the curve on their IT systems, and it is not uncommon for them to be really behind when it comes to an online presence. Even though so many have websites, many companies often don’t put much thought into how those site can help them and help clients, customers, partners and investors (or media, for that matter).

I’d say most of the Big Pharma and even mid-sized companies I’ve run across pretty much “get it” in terms of websites (and many smaller companies, too, though I’m shocked to find every few months a young biotech that seeks media and investor attention yet fails to have at least a rudimentary website). Well, aside from photos archives. As a member of the media, I urge more pharmas and biotechs to take good headshots, facility shots and candid shots of employees (lab workers, for example) and have them easily downloadable online in high-resolution formats. I’ll never understand why so many huge companies fail to offer that.

But I digress.

What I wanted to get at was the social media options, an area in which so many companies just miss the boat entirely, both inside and outside of pharma. With Twitter, Facebook and LinkedIn, just to name three biggies, there is no excuse for a company not to at least try to make good use of at least one, and ideally more than one. To not use social media in some way seems a sure way to show that you are behind the times. Blogs, too, are an important area to consider, either separate from or integrated into the company website.

Not everyone will use social media to the best of their potential, but then again, they don’t need to get it perfect. Not everyone nails it with marketing/advertising, employee communications, project management or public relations, either. We can’t all be good at everything.

But every company should be somewhere in terms of social media, and in that vein, I wanted to share a roundup with you of some “top 10” efforts by pharmas in the realm of social media posted on slideshare.net. It shows some notable example of what has been done by Johnson & Johnson, Glaxo-Smith-Kline, Bayer, sanofi-aventis, Novartis, AstraZeneca, Bristol-Myers Squibb, Roche, Pfizer  and Boehringer Ingelheim.

Sure, the original post was put up two years ago, but it still serves as a good example of what pharmas can do with social media, when they put their minds (and sometimes hearts) into the effort:

Click here to see the slideshow.

November 15, 2010 Posted by | Corporate | , , , , , , | 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

Q+A with the stem cell case plaintiffs

On the cover of our November issue (which you can download here), you can read about a controversial lawsuit that is at the center of one of our nation’s hottest current debates: embryonic stem cell (eSC) research. (See the story here.)

The lawsuit, Sherley, et al., v. Sebelius, et al., alleges that the order signed by President Barack Obama in March 2009 lifting a previous ban on federal funding for eSC research violates the Dickey-Wicker amendment, a 1995 law prohibiting the government from appropriating funds for research that involves the creation or destruction of human embryos for research purposes. The lawsuit also contends that President Obama’s order has intensified competition for government research funds—which are already in short supply—for researchers engaged in other kinds of stem cell research.

The case has been making its way through the courts for a while, but it made headlines in August when the U.S. District Court for the District of Columbia issued a preliminary injunction in the case, essentially bringing funding for embryo-destructive research to a screeching halt while the case is under consideration.

With the research community in uproar over the decision, less than a month later, the U.S. Court of Appeals temporarily suspended the injunction, arguing that it would cause irreparable harm to researchers, taxpayers and scientific progress while the case is appealed.

While Sherley v. Sebelius concerns the interpretation of law and competitive issues, the case has renewed the debate over the practice of stem cell research in the United States, a political and moral tug-of-war that has been waged for decades.

The debate centers on the creation of a human embryonic stem cell (eSC) line, which requires the destruction of a human embryo. Advocates of the pro-life movement are concerned with the rights and status of an embryo as an early-aged human life and equate eSC research with murder. Those opposing this view argue that these embryos are to be destroyed or stored for long periods of time past their viable storage life, and point out that stem cell research has the potential to dramatically alter approaches to understanding and treating diseases, and to alleviate suffering.

Science holds pros and cons for both sides of the moral debate. Adult stem cell research has achieved great levels of success and potential, but these stem cells are generally limited to differentiating into different cell types of their tissue of origin. Although some researchers are of the opinion that the differentiation potential of eSCs is broader than most adult stem cells, they may be rejected by the immune system—a problem that would not occur if a patient received his or her own stem cells.

Dr. James Sherley

As the case continues to play out in court, media attention is turning to the lead plaintiffs in the case, 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. Although the pair admit they did not know each other prior to the case unfolding—they were reportedly “recruited” by attorneys seeking to challenge President Obama’s order—they both have certain beliefs about the ethics involved in eSC research, and strongly support a focus on adult stem cells.

Sherley, whose research focuses on the molecular and biochemical mechanisms of adult stem cells, has long been vocal about his opposition to human eSC research. He has described the position that eSCs hold the promise to cure or treat debilitating diseases “misinformation,” maintaining that adult stem cell research is “a viable and vibrant path to new medical therapies.” Sherley also once made headlines for protesting a decision by the Massachusetts Institute of Technology (MIT) to deny him tenure by going on a 12-day hunger strike. Sherley, who is African-American, has also publicly said he believes that MIT did not give him the freedom to challenge scientific orthodoxy the way the institution would have for a white colleague.

Dr. Theresa Deisher

Deisher, who works exclusively with adult stem cells, founded AVM Biotechnology “in response to growing concerns about the need for safe, effective, affordable and ethical medicines and therapeutic treatments,” with help from private donors. According to the company’s website, “The use of aborted fetal tissue and embryonic cells in the discovery, development and production of vaccines and pharmaceuticals … make it difficult for many physicians, pharmacists, scientists and healthcare professionals to navigate their fields of expertise without sacrificing their consciences.” You can see some of Deisher’s writing on the subject here.

As media scrutiny has intensified in the wake of the case, Sherley and Deisher have backed away from many interviews, but were gracious enough to take questions from ddn regarding their views about eSC research. Here are their responses:

ddn: What should the goal of stem cell research be?

Sherley: Like other NIH-funded research, the goal should be to increase our scientific knowledge about the natural world through the conduct of ethical scientific research towards the goal of improving human health.

Deisher: The goal should be to develop safe, effective and affordable therapies for human disease, adhering to the highest scientific ethical standards.

ddn: Are you against embryonic stem cell research as a practice, or the federal funding of it, or both? Why?

Sherley: Specifically, I wish to educate and alert the public that, first and foremost, human embryonic stem cell research is unethical according to pre-existing NIH guidelines for human subjects research; that its funding by NIH is illegal according to U.S. law as articulated by the Dickey-Wicker amendment; and that it continues to be misrepresented by many of its proponents who misstate its potential for providing medical advances and present it as if there were no alternatives, when if fact both adult stem cell research and traditional disease research are not only effective alternatives, but better ones in many respects.

Deisher: Human embryonic stem cell research does not meet the high ethical standards test. A human being is necessarily destroyed in the process of obtaining human embryonic stem cells, which is not an acceptable outcome according to U.S. human subjects guidelines. Additionally, the research is not necessary, another requirement of our human subjects guidelines, as superior alternatives are available using adult stem cells. According to human subjects research guidelines, even if parents give consent, research cannot be done if it is not necessary. Human subjects guidelines should be applied to all research, regardless of funding source, and should be applied to regulate research on human embryos.

ddn: What are viable alternatives to embryonic stem cells? How soon will they bring about therapies? What is their commercial potential?

Sherley: The viable alternatives are both adult stem cell research and traditional disease research. In particular, adult stem cell research addresses the development of new therapies based on repairing tissues or replacing tissues with regenerative cells. Such therapies based on adult stem cells are already a part of standard clinical practice. Bone marrow reconstitution with blood stem cells is one of the best known examples, but there is a large body of clinical research underway both to make blood stem cell treatments even more effective and to develop new therapies based on other types of adult stem cells. This clinical research includes commercial development of therapies for diseases like diabetes based on developing adult stem cells that renew the cells that make insulin. It is important that the public understands that proposed treatments based on human embryonic stem cells invariably require that they be converted into either adult cells or adult stem cells, which are ultimately required for any therapy that will repair, replace, or treat tissues in children and adults. When the public knows this, it then becomes imperative for it to ask proponents of human embryonic stem cell research, “What is your motivation?”

Deisher: Adult stem cell therapies are in late-stage clinical trials, having advanced extremely rapidly since their discovery in the late 1990s, entering clinical trials by 2002.  Prior to the late 1990s, scientific dogma held that adult stem cells did not exist outside of the blood system. These novel discoveries have brought promise to many patients suffering from grievous illness; unfortunately, the United States lags behind the rest of the first world in advancing these therapies because our academic scientists and elected officials have preferentially advanced human embryonic stem cell research, which is currently helping no one. Other alternatives include therapies that block tissue destructive pathways. For instance, Enbrel is a drug for rheumatoid arthritis that blocks the joint destroying action of a molecule called TNF. Once the destructive pathway is blocked, naturally present regenerative processes are able to replace the damaged joints.

ddn: Describe some of your current work in this area.

Sherley: My laboratory’s research is focused on developing methods for production of adult stem cells, discovering biomarkers that can be used to quantify adult stem cells, and elucidating cellular mechanisms that are important for adult stem cell function, health and longevity.

Deisher: My research focuses on the efficient delivery and retention of stem cells in diseased organs.

ddn: What should the government’s role be in stem cell research being done in the United States?

Sherley: Through its agent the NIH, its role should be the same as for other areas of research: Adhering to U.S. law, foster and fund ethical, high-quality research that has potential to positively impact human health.

Deisher: (References the NIH’s mission statement, which states, “NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life and reduce the burdens of illness and disability. The goals of the agency are: To foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health; To develop, maintain and renew scientific human and physical resources that will ensure the nation’s capability to prevent disease; To expand the knowledge base in medical and associated sciences in order to enhance the nation’s economic well-being and ensure a continued high return on the public investment in research; and to exemplify and promote the highest level of scientific integrity, public accountability and social responsibility in the conduct of science.”)

Highlighted in red are NIH mandates that are not met by NIH funding of human embryonic stem cell research. The government’s role should be to actively promote research and clinical trials in areas that would not be adequately advanced by private industry. Adult stem cells from a patient’s own blood, bone marrow or other organs are not patentable, and therefore, absolutely require federal funding to bring these remarkable treatments to U.S. citizens. As taxpayer funds are used by the government for these purposes, one would hope that affordability would also be an important criterion for federal funding of clinical trials. Adult stem cell therapies are affordable, and will cost on average about $25,000, while embryonic stem cell therapies, if ever available, will be expensive and beyond the means of almost all U.S. taxpayers. Geron Corp. issued public statements in January 2009 estimating the cost of human embryonic stem cell-based therapies for spinal cord injury to be just under $500,000. Geron received significant NIH funding for this work.

ddn: How does the 2009 executive order from President Obama impact your access to research funds?

Sherley: Because the president’s order led to NIH instituting the illegal funding of human embryonic stem cell research, it injures all U.S. scientists working in other fields who compete for the same limited NIH resources. However, the greater injury is sustained by scientists whose research focuses on the recognized alternative to human embryonic stem cells, adult stem cells, because of the juxtaposition of all stem cell research applications in the NIH review process. At each phase of the NIH review process, bias and contempt, inspired by an illegal implementation of the president’s order, can occur against their research applications, even though they may be of the highest quality.

Deisher: The executive order initiated a process where preference in NIH requests for grant proposals and ultimate grant funding is now directed towards embryonic stem cell research. The 2009 executive order amplified congressional obsession with funding embryonic stem cell research, apparent since 2006. Every adult stem cell scientist and clinician is injured by the preferential emphasis and funding of embryonic stem cell research. Most egregiously, U.S. citizens are being denied adult stem cell therapies that are in development in Europe and other countries for heart attack, blindness, paralysis, stroke, diabetes, multiple sclerosis, lupus and other grievous human illness.

ddn: What can Americans do to get past the moral arguments in favor of or against embryonic stem cell research, in order to make sure that we are still working toward finding cures for devastating diseases and conditions?

Sherley: Americans would have no dilemma to ponder, if they were better informed that human embryonic stem cells have very little potential to lead to cures for devastating diseases and conditions. The No. 1 sales pitch pushed for these cells, the “ability to make any cell in the body,” is their fatal flaw for providing new medical therapies. For effective tissue and organ therapies, regenerative cells are needed that can continuously replace the mature cells found in just the sick or ailing tissue or organ. Human embryonic stem cells cannot do this. Adult stem cells can. Since human embryonic stem cells make other cells that are not needed, if they were used, they would give the patient another well-known, very difficult-to-treat disease.

Deisher: Science should never be above moral scrutiny and one only needs a brief history lesson to know this. On another note, I hear arguments regularly that we should not deter human embryonic stem cell research because of the moral objections of a minority. This is absurd, as our entire scientific research ethical oversight is predicated on respect for the moral objections of a minority in our country. Respect for animal rights and concern for ethical research conduct using animals in experiments regularly deters experiments that are scientifically and economically expedient. Respect for ethical concerns as they relate to human subjects research should receive no less deference. However, Americans do not need moral arguments to oppose embryonic stem cell research; embryonic stem cells are known to form tumors, they would require lifelong immune suppression that itself can cause hypertension, osteoporosis and other nasty side-effects, and human embryonic stem cell products would be too expensive for Americans to afford.

Deisher was also kind enough to field questions about how her Catholic faith informs her approach to stem cell research. We’ll bring you that Q&A very soon.

November 10, 2010 Posted by | Academia & Non-Profit, Government, Labwork & Science, Uncategorized | , , , , , , , , , , , , , | Leave a comment

Genzyme and sanofi continue on…and on…and

There is a good reason why professional arm wrestling isn’t a major television draw. For all the complaints of how boring baseball or golf is to watch, things do change and tides turn in dramatic fashion amid the slow portions. But watching two people with interlocked hands staring each other down while muscles bulge…until finally one opponent just loses the will or strength to continue?

No, not interesting to most people.

In many respects, the sanofi-aventis attempt to acquire Genzyme (whether by willing merger or takeover) is beginning to feel like arm wrestling. It’s only interesting if you’re one of the competitors. Or you have a bet placed.

So, in recent days, sanofi has once again invited Genzyme to come to the table and talk (see this story coming out of Boston, for example, or this one from the Wall Street Journal). Genzyme, in turn, has said “There’s not enough money on the table yet to convince us show up!” (I paraphrase wildly, of course). We’ve been held at a $69 per share offer so long, and the back-and-forth repetition from both sides as to why they won’t budge that…Zzzzzzz

Wha….! Huh?!!!!

Seriously, though, as repetitious as this is seeming, there are little gems of information and insight to be gleaned.

For one thing, despite inviting Genzyme to come back to the table after threatening to take them over, sanofi is still showing its assertive streak by warning the Cambridge, Mass.-based company not to turn to its state’s takeover protections and swallow the proverbial “poison pill” to fend off a hostile acquisition (see this Bloomberg story).

At one website where the latest overtures and refusals had been aired as news, a comment was posted that said, essentially: “Maybe it’s time for sanofi to walk away long enough for Genzyme’s shares to drop back into the 40s and then let Genzyme’s top brass explain the real value of their shares to the stockholders.”

I don’t know that I agree Genzyme isn’t worth more than $69 per share. Maybe it is, maybe it isn’t. But it is certain that the stock rose on the news of a sanofi merger (or takeover). The continued presence of sanofi as an eager suitor (or conqueror) doesn’t seem likely to drive down stock prices. One can only wonder whether with no rival suitors sanofi might be better off stepping away for a time. But then again, with the pressures Big Pharma is facing right now with patents expiring and pipelines being sluggish, perhaps sanofi can’t afford to do that.

It’s also worth putting the current situation into perspective relative to sanofi’s third-quarter earning report in late October. Commenting on those earnings, which were up 13 percent, analyst Simon King of Datamonitor wrote:

“Sanofi-Aventis’s increasing diversified business model is reaping rewards as growth across consumer, generic and vaccine divisions has helped to compensate for generic competition within the branded pharmaceutical segment. However, generic erosion continues to impact performance, driven in part by the somewhat unexpected approval of a generic Lovenox product. With Plavix sales also in decline due to loss of European patent exclusivity, Sanofi-Aventis’s anti-thrombotic empire is in collapse.

“These results occur against a backdrop of continued negotiation regarding Sanofi’s proposed acquisition of Genzyme. Sanofi has used its results announcement to launch its latest salvo towards Genzyme shareholders by suggesting that nothing has been said that will change its current offer. Genzyme though is now being very bullish in terms of sales forecasts – which will be heavily dependent on reversing the loss of sales to Shire in specialist markets and the success of Campath in multiple sclerosis.”

King notes that Genzyme’s stance could backfire, particularly if sanofi does decide to walk away and no other bidders emerge. However, he remains convinced that the Genzyme acquisition “fits the sanofi model.”

For now, it’s still an arm wrestling match. We’ll keep our eyes on it, and let you know who wins in the end…or if we get a draw.

(By the way, sanofi’s public announcement about the latest back and forth is here and Genzyme’s official take is here.)

November 9, 2010 Posted by | Corporate, M&A activity | , , , , , , | 1 Comment