Wednesday, January 31, 2007

NPR : Study: TV Ads Overstate Benefits of Medication

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Morning Edition, January 30, 2007 · The amount of money drug companies spend on TV ads has doubled in recent years. Studies show they work: Consumers go to their doctor with a suggestion for a certain prescription drug they saw advertised on TV. Now a study in the Annals of Family Medicine raises questions about the message the ads promote.

You're most likely to see drug ads during prime time, especially around the news. Researchers analyzed 38 ads aimed at people with conditions like hypertension, herpes, high cholesterol, depression, arthritis and allergies.

The drug industry says the ads arm consumers with information. Researchers found that the information was technicallly accurate, but the tone was misleading.

"Typically, what we would see with these ads is that before taking a particular prescription drug, the character's life is out of control and the loss of control extended beyond the impact of their health condition," says UCLA psychologist Dominick Frosch, who headed the study.

For example, herpes patients were portrayed as being incapacitated for days. Insomniacs were utterly out of synch on the job. Depressed patients were friendless and boring at parties.

"When the character is then shown taking the drug, he then magically regains complete control of his life," Frosch notes.

None of the ads mentioned lifestyle changes that could also help treat the condition. That's not surprising, given that the ads are just another form of mass marketing.

But prescription medicines are not soap.

Dr. David Kessler, dean of the school of medicine at the University of California, San Francisco, headed the FDA for seven years, under the first President Bush and then President Clinton. He opposed TV advertising for drugs.

"We tend to forget pharmaceuticals are powerful agents, not just any commodity," he says. "Advertising them based on their emotional appeal is something that has great risks."

After Kessler left the FDA, rules were relaxed and TV ads for drugs were permitted. That was a mistake, Kessler says.

He insists the FDA should be responsible for insuring overall accuracy, both in tone and content. And he says the agency should ask this question:

"Does the ad in the end convey a fairly balanced view of what this drug is going to do — not some wish list?"

Kessler says a complete ban on TV ads for prescription drugs is unlikely, now that ads has been approved. But he says regulation can — and should — be tightened.


http://www.npr.org/templates/story/story.php?storyId=7077201

Tuesday, January 30, 2007

MS 50% More Common In U.S. Than Thought?
Tracking Study Of Neurological Disorders Shows 1 In 1,000 Americans Have Multiple Sclerosis

Jan. 29, 2007

(CBS/AP)

Quote

"Our estimate of MS prevalence is about 50 percent higher than a comprehensive review from 1982."

Deborah Hirtz, M.D.

WHAT DO YOU THINK?




(WebMD) Multiple sclerosis (MS) may be 50 percent more common in the United States than previously thought, according to a new research review.

Almost one in 1,000 people in the United States has MS, according to the review.

"Our estimate of MS prevalence is about 50 percent higher than a comprehensive review from 1982," says researcher Deborah Hirtz, M.D., in an American Academy of Neurology news release. "Whether this reflects improvement in diagnosis or whether incidence is actually increasing deserves further study," says Hirtz, who works at the National Institute of Neurological Disorders and Stroke.

Hirtz and colleagues analyzed about 500 studies published from 1990 to 2005 to track 12 neurological disorders. Their findings appear in the Jan. 30 issue of Neurology.

The researchers tracked the prevalence (total number of cases) of the following conditions:

  • Migraine: 121 in 1,000 people
  • Epilepsy: 7.1 in 1,000 people
  • Alzheimer's disease: 67 in 1,000 people 65 or older
  • Parkinson's disease: 9.5 in 1,000 people 65 or older
  • Autism spectrum disorders: 5.8 in 1,000 children
  • Cerebral palsy: 2.4 in 1,000 children
  • Stroke: 10 per 1,000 people
  • Traumatic brain injury: No prevalence estimates available
  • MS: 0.9 in 1,000 people
  • Spinal cord injury: No prevalence estimates available
  • ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease): 0.04 in 1,000 people
  • Tourette's syndrome: No prevalence estimates

    These conditions aren't necessarily the most common neurological disorders, note Hirtz and colleagues. For instance, they didn't track sleep disorders, chronic pain, or mental retardation. And though autism and cerebral palsy are lifelong conditions, data were only available for cases in children.

    Besides the rise in MS prevalence, the researchers also note a "possible" increase in nonfatal stroke and a "substantial" rise in Alzheimer's disease, compared with the 1982 review. Those trends are likely due to America's aging population and better diagnosis, according to the review.

    Traumatic brain injuries are down by about half since the 1982 review.

    "It is likely that this reflects more restrictive hospital admission criteria, although improvements in motor vehicle safety may also contribute," write Hirtz and colleagues.

    They note no major changes in rates of cerebral palsy, epilepsy, migraine, ALS, or Parkinson's disease. Previous estimates weren't available for autism spectrum disorders or Tourette's syndrome.

    Past data were "too sparse" to track trends in spinal cord injury, the researchers say.

    Since high-quality U.S. data on most disorders were lacking, the researchers often applied data from other countries to the U.S. population. That approach isn't ideal, the researchers admit. They call for better studies to track neurological disorders in the United States.

    Still, they say, their findings show "the burden of neurologic illness affects many millions of people in the United States."


    SOURCES: Hirtz, D. Neurology, Jan. 30, 2007; Vol. 68: pp. 326-337. Albert, S. Neurology, Jan. 30, 2007; Vol. 68: pp. 322-323. News release, American Academy of Neurology.



  • By Miranda Hitti
    Reviewed by Louise Chang, M.D.
    Copyright 2007, WebMD Inc. All rights reserved.


    http://www.cbsnews.com/stories/2007/01/29/health/webmd/main2410927.shtml?source=RSSattr=Health_2410927


    Multiple Sclerosis Association of America Produces a Monograph on Complementary and Alternative Medicine for the ...
    U.S. Newswire via Yahoo! News Mon, 29 Jan 2007 10:12 AM PST
    The Multiple Sclerosis Association of America (MSAA) has produced a monograph titled, Thinking about Complementary and Alternative Medicine? The monograph provides an introduction for people with multiple sclerosis (MS) on how to find and evaluate claims about complementary and alternative medicine (CAM). This is the first of two monographs MSAA is publishing through a grant from Berlex. Both ...

    ReceptoPharm Begins Phase IIb Human Clinical Trial for the Treatment of Adrenomyeloneuropathy
    RedNova Mon, 29 Jan 2007 9:15 AM PST
    Nutra Pharma Corp. (OTCBB:NPHC), a biotechnology company that is developing drugs for HIV and Multiple Sclerosis has today announced that ReceptoPharm had commenced its Phase IIb clinical trial in subjects with Adrenomyeloneuropathy (AMN).

    Tanabe Resumes MS Drug Study
    RedNova Mon, 29 Jan 2007 9:16 AM PST
    Japanese pharmaceutical company Tanabe Seiyaku has resumed a phase II trial of its multiple sclerosis treatment after the FDA released its clinical hold on the study.

    A diet of worms could keep MS at bay
    New Scientist Sun, 28 Jan 2007 11:27 PM PST
    Parasitic worms could improve the prospects of people with autoimmune diseases such as multiple sclerosis

    Chopping Off Protein Puts Immune Cells Into High Gear
    Medical News Today Mon, 29 Jan 2007 7:01 AM PST
    The complex task of launching a well-organized, effective immune system attack on specific targets is thrown into high gear when either of two specific enzymes chop a protein called LAG-3 off the immune cells leading that battle, according to investigators at St. Jude Children's Research Hospital. [click link for full article]

    Medical cannabis is a blunt tool
    New Scientist Sun, 28 Jan 2007 11:37 PM PST
    Results of clinical trials of cannabis have been mixed and it now seems there are fundamental problems with how our bodies respond to the stuff

    Autoimmune Disease Breakthrough Gained By Identification Of 30 Errant Genes
    Medical News Today Mon, 29 Jan 2007 0:03 AM PST
    A report in the January issue of Nature magazine announces that one more step in understanding what may cause the body to attack itself in its war against autoimmune disease has been discovered by researchers at the Massachusetts Institute of Technology's Whitehead Institute, says the Autoimmune Related Diseases Association (AARDA), a national nonprofit patient advocacy organization. [click link ...

    New Prince Edward Island Research Centre to Play a Critical Role in Advancing Health Care
    Government of Canada News Mon, 29 Jan 2007 6:40 AM PST
    A new research and service centre made possible by partnerships formed among governments and the private sector is now open for business on the University of Prince Edward Island (UPEI) campus.

    When your stock dives for no apparent reason
    MSN Money - USA
    The company presented at the JPMorgan Healthcare conference two weeks ago and left the overall impression that Tysabri sales were ramping nicely and that an ...

    Investors, Caution: Biologics Have Side Effects Too
    Seeking Alpha - New York,NY,USA
    And when Tysabri was withdrawn, many were stunned that a biologic apparently could have serious side-effects. This may also be one of the reasons why so ...

    Infineon, Munich Re, Pernod, Wincor: European Equity Preview
    Bloomberg - USA
    (ELN ID): The company which reintroduced the Tysabri multiple sclerosis treatment in July is scheduled to release fourth-quarter results. ...

    Sunday, January 28, 2007

    KTLA The CW | Where Los Angeles Lives | A vaccine development 'renaissance'
    A vaccine development 'renaissance'

    Technology, boosted funding and higher profits are a shot in the arm for development.



    January 28, 2007

    Breakthroughs in technology, increased funding and higher profits are spurring a boom in vaccine discovery and development that could save or improve the lives of millions of people by attacking such scourges as cancer and malaria.

    Three new vaccines arrived on the market in 2006, the most in a single year. They include vaccines for the human papillomavirus, linked to cervical cancer, and for rotavirus, which causes severe diarrhea and kills 600,000 children globally each year. Another prevents shingles in the elderly.

    As early as the end of the decade, scientists say, there may be new immunizations against herpes simplex and rheumatoid arthritis and a better seasonal influenza vaccine.

    Researchers also are talking about a potential vaccine within five years to fight malaria — long one of mankind's deadliest and most elusive adversaries.

    Other scientists are making progress with what are known as therapeutic vaccines, which fight already diagnosed diseases or conditions, including cancer and Alzheimer's, or addictions to substances such as nicotine, by "teaching" the body to fight back. They're further down the road but hold the potential to transform medical care, experts say.

    "It may turn out we have a perfect storm here of several different things coming together at the right time. This is a tremendous time of opportunity for both the developed and the developing world," said David Fleming, director of the Bill & Melinda Gates Foundation's global health strategies program, which has made vaccine development and access a cornerstone of its mission.

    "It's clear there is a renaissance going on around vaccines," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. "We have made more progress with some [vaccines] in the past few years than we have in the past 30."

    The current immunization boom could rival or even surpass the Golden Age of vaccine development between the late 1940s and early 1960s, experts say, when scientists such as Jonas Salk discovered inoculations for polio, flu, mumps and measles. But relatively few vaccines were found in the decades that followed, partly due to lack of profitability for drug companies and reduced vaccine research funding.

    Perhaps the best evidence of a vaccine revival is that the pharmaceutical industry is returning to the market.

    Drug giant Pfizer Inc., which shuttered its human vaccine unit in 1976, reopened it in the fall by acquiring a small British vaccine company. Even with planned layoffs announced last week, Pfizer says it intends to increase funding in its vaccine business.

    Novartis and GlaxoSmithKline recently have invested billions expanding their vaccine trades by buying up smaller players and expanding research programs.

    Jean Stephenne, president of GlaxoSmithKline Biologicals, expects his company to have five new vaccines in the next five years and that its vaccine business will grow from 6% of the company's sales this year to 14% by 2010.

    Overall, the number of vaccines in development has risen from 285 in 1996 to 450 today.

    Drug executives say they can charge considerably more for today's vaccines — up to several hundred dollars or more — versus a few dollars for older vaccines.

    Prevnar, a vaccine introduced in 2000 to treat pneumococcal pneumonia — the cause of up to a quarter of all community-acquired pneumonia cases each year — runs about $250 for a four-shot series. It became the first vaccine to clock $1 billion in annual sales, giving it so-called blockbuster status.

    Overall, the vaccine industry rang up $10 billion in sales in 2005, up from $6 billion in 2002. The market is estimated to reach $15 billion by the end of the decade.

    Other factors increasing industry confidence in the sector: more funding from donors like the Gates Foundation, and novel proposals for increased vaccine research.

    Typically, Third World countries can't afford to buy new vaccines and don't get access to them until a generation after their introduction, if ever. The lack of potential profits has blunted many drug companies' interest in researching and producing vaccines to treat diseases, such as malaria, found predominantly in poorer countries.

    But that is slowly changing. At the Group of 8 summit in Russia last year, several countries proposed upfront financing for vaccine development, creating incentives for manufacturers.

    And Geneva-based GAVI Alliance, a partnership created in 2000 that counts among its sponsors the United Nations, the World Health Organization and the Gates Foundation, is investing hundreds of millions of dollars to expand vaccine research and distribution.

    At the World Economic Forum in Davos, Switzerland, last week, GAVI announced it would commit an additional $500 million over three years to strengthen healthcare systems in poor countries, a key problem in implementing vaccine programs in many locales. The organization says it has prevented 2.3 million deaths from disease since its inception, including 600,000 last year.

    "The GAVI story is probably one of the greatest success stories of all time," Bill Gates said Friday in an interview with CNBC.

    Vaccine access in industrialized countries can also be spotty. In the U.S., African Americans and Latinos have significantly lower immunization rates than other groups. And when a vaccine arrives on the market, it's not guaranteed to be covered by insurance.

    While insurers deny it, doctors say the companies often wait a year or more before deciding to reimburse patients for a vaccine, hoping an initial surge of people will get immunized on their own dime.

    This fall, Kelsey Boesch, 18, of Los Angeles paid about $300 for Gardasil, the vaccine against HPV. The three-shot regimen wasn't covered by her family's insurance.

    "I hadn't heard about it, but when [my doctor] explained it to me, I didn't think twice," Boesch said.

    Experts say mounting scientific and business momentum around vaccines could stall at any time, and several promising vaccine candidates remain in early clinical trials.

    Last month, the federal government canceled its 5-year-old, $900-million anthrax vaccine program after the company failed to meet a deadline to test it in people. Vaccines for major killers like HIV, the virus that causes AIDS, and tuberculosis remain years, if not decades, away.

    And drug companies have previously dipped their toes back in the vaccine market only to leave shortly after.

    But even if only a handful of additional immunizations are found, it could have enormous impact on global health.

    Malaria kills up to 3 million people a year. A less-fragile supply of flu vaccines could also have a major effect.

    Vaccines are weakened or killed parts of bacteria or viruses that are injected into the body to stimulate antibodies that then provide immunity against that bacteria or virus.

    Scientifically speaking, the last wave of vaccines half a century ago went after many of the "low-lying fruits but didn't help us with the more complex viruses and bacteria," said Warner Greene, director of the Gladstone Institute of Virology and Immunology at UC San Francisco.

    The fact that half of vaccine manufacturers dropped out of the market by the late 1970s exacerbated the problem.

    But Greene said major recent advances in vaccine technology had made finds considered unattainable a decade ago look possible.

    Improved understanding of immune responses has led to more elusive vaccines, like the ones that have arrived in recent years. Better understanding of the genetic structure of bacteria and viruses, and how to get the body to respond to them more effectively, is fueling the growing optimism for malaria vaccines and other treatments.

    In 2004, a small clinical trial of 2,022 children in Mozambique found an experimental vaccine cut the risk of developing severe malaria by 58%.

    Separate advances are likely to increase the ability to produce influenza vaccines for routine immunization and, possibly, to protect against a global influenza pandemic.

    Traditionally, flu vaccines are grown in millions of fertilized chicken eggs, which can take up to six months. The lengthy process makes it hard for drug makers to keep up with mutating flu strains and limits the amount of vaccine they can produce quickly each flu season.

    The egg-based method is problematic for bird flu vaccines because the disease threatens chickens and the egg supply needed to grow the vaccines.

    So pharmaceutical companies are developing two methods — using cell cultures and DNA cloning — that could speed things up.

    Instead of growing the vaccines in eggs, scientists are trying to use cell cultures, which is how vaccines for chicken pox, hepatitis A and polio are made. This summer, the federal government awarded five companies a shared $1 billion to research and implement cell process, which could cut in half the development time for seasonal flu vaccines.

    Researchers also are making progress with what are known as DNA vaccines especially for use against the flu. These are made with single genes of a virus, and injected into the skin to produce an immunological response.

    Although no DNA vaccine has proved effective yet, scientists say it's a much more direct method for immunizations that holds enormous promise.


    daniel.costello@latimes.com

    *

    (INFOBOX BELOW)

    Immunization boom

    Vaccines recently approved or expected soon:

    • Pneumococcal disease:

    Approved in 2000

    • Human papillomavirus:

    Approved in 2006

    • Rotavirus gastroenteritis,

    children:

    Approved in 2006

    • Shingles, adults:

    Approved in 2006

    • Herpes simplex:

    Expected arrival in 2008

    • Rheumatoid arthritis:

    Expected arrival in 2012

    • Multiple sclerosis

    Expected arrival in 2012

    Source: Times staff

    http://ktla.trb.com/news/la-fi-vaccines28jan28,0,4138897.story?coll=ktla-news-1

    Caring for America's health
    BBC News Sat, 27 Jan 2007 4:14 AM PST
    Justin Webb is reunited with an old friend and discovers just how much the US health care system has let him down over the last 15 years.

    Autoimmune Disease Breakthrough Gained by Identification of 30 Errant Genes
    Newswise Sat, 27 Jan 2007 9:25 AM PST
    A report in the January issue of Nature magazine announces that one more step in understanding what may cause the body to attack itself in its war against autoimmune disease has been discovered by researchers at the Massachusetts Institute of Technology's Whitehead Institute, says the Autoimmune Related Diseases Association (AARDA), a national nonprofit patient advocacy organization.

    Medical Edge: Plasma exchange used as treatment, not cure, for MS
    The Bryan-College Station Eagle Sat, 27 Jan 2007 6:04 AM PST
    A course of plasma-exchange treatments, which typically takes about two weeks, does lower antibody levels, which are considered the culprit in some MS cases - but for less than three months.

    Weill Cornell Ushers in New Era for Patients, Opening and Naming the Weill Greenberg Center
    Newswise Sat, 27 Jan 2007 8:25 AM PST
    Weill Cornell Medical College today officially opened and dedicated its new Ambulatory Care and Medical Education Building. The unique 13-story, 330,000-square-foot Weill Greenberg Center will serve as the new focus for patient care and education at the Medical College and provide a state-of-the-art health-care resource for the people of New York, the region and beyond.

    Botox isn't just for wrinkles anymore
    WABC-TV New York Fri, 26 Jan 2007 2:39 PM PST
    Botox isn't just for helping get rid of wrinkles. There is a new use for it. Seven's On Call with Dr. Jay Adlersberg.

    A vaccine development 'renaissance'
    KTLA 5 Sun, 28 Jan 2007 0:04 AM PST
    Technology, boosted funding and higher profits are a shot in the arm for development.


    Who’s Afraid of Single Payer?

    by Stephen Fleischman | Jan 28 2007 - 9:32am | permalink
    article tools: email | print | read more Stephen Fleischman

    Who’s afraid of the single payer health plan, otherwise known as National Health Insurance? Big Pharma and the medical establishment, that’s who—because “single payer” is the big bad wolf that’s huffing and puffing and is about to blow their house down. And it’s a big house, bloated by excess profits, government subsidies and sheer theft of the people’s money.

    To paraphrase our former President, Richard Nixon, “you’re not going to have America’s healthcare system to kick around forever.”

    Health Insurance has been a political football in this country for decades. It’s been on every politician’s laundry list, in one form or another, in every election. There have been employer plans; there have been government plans; city, state and federal plans. It’s been brought up again and again in every State of the Union address, year after year. Despite all the talk and attention by both parties, census figures show that a record 46.6 million Americans, including 8.3 million children, have no health insurance at all, at a time when the cost of health care has gone through the roof. How can they afford to see a doctor or fill a prescription?

    Are we going to go on talking the talk and getting ripped off by Big Insurance forever? Why can’t we have what every other industrialized nation in the world enjoys—some form of national health insurance?

    That may be the first question some Democratic Congressman or Senator may ask now that they have a majority in both houses of Congress—but I doubt it.

    A look back at the endless squabble over health care in this country will reveal where this timidity comes from.

    It all began with the bug-a-boo of “Socialized Medicine” raised by the American Medical Association after World War II when they saw their “fee-for-service” system being threatened. The system was: You go to the doctor, you get a service and you pay a fee; and that’s the way they wanted to keep it, by God!

    But after the war, something new was blowin’ in the wind. People like Henry Kaiser, the auto maker and ship builder, came up with a Health Maintenance Organization (HMO) for his employees. You pay a small monthly fee, you get your entire medical and hospital needs free of any other charges.

    The city of New York jumped right in with HIP (Health Insurance Plan of Greater New York), a pre-paid health plan for city employees.

    “Socialized medicine!” screamed the AMA. Physicians and surgeons manned the battle stations. Many saw their seven figure incomes taking flight.

    Other HMOs mushroomed around the country. And then, in 1965, President Lyndon Johnson made “medical care for the aged” part of his Great Society package. We know it today as Medicare. Then came Medicaid, medical care for the indigent. The flood gates were opened. For the first time, huge amounts of government money started pouring into the health care system.

    The insurance industry knew a good thing when they saw it. Organized medicine, the AMA and its state and county medical societies, did not—paralyzed by the fear of government intrusion.

    Insurance companies relished the enormous cash flow of government money emanating from Medicare and Medicaid and other government programs like Champus, medical coverage for servicemen and their families.

    Insurance companies set up their own private plans, yes, HMOs, to sop up all that loose cash. They turned pre-paid plans into their opposite—not “socialized medicine” for the people but corporate welfare for the insurance companies. Through the years, they increased premiums and cut services, raking in billions in profits instead of providing not-for-profit medical services to their subscribers. The doctors allowed themselves to be co-opted and blind-sided. They allowed the pre-paid plans to get away from them. Their fear of “socialized medicine” dimmed their vision.

    Instead of “socialized medicine” the doctors got privatized sweatshops where some doctors can’t make medical decisions without the approval of an HMO bureaucrat. Managed care became mismanaged medicine.

    The epitome of outrage was Hillary and Bill Clinton’s opportunistic brainstorming of a National Health Plan in 1992. They devised a government health plan they knew would never work. They dangled it before the nation. They were too politically sophisticated not to know they were playing right into the hands of the insurance companies.

    The Clintons set the national health care movement back a generation. Now, Hillary Clinton is running for president in 2008. What’s her health care program? More of the same. Single payer? No way.

    The current health insurance system violates the very essence of the insurance principle—the widest coverage for the least cost. The larger the pool, the more efficient the system.

    In the current US system, there are literally tens of thousands of different, and overlapping, health care organizations generating a blizzard of paperwork in an administrative wilderness creating enormous waste—thousands, if not millions of people pushing paper around. They are driving doctors, trying to do a job, up the wall with the different forms needed to be completed in order to get paid, to say nothing of patients fighting their way through a jungle of obstacles trying to get the health care they need.

    A single payer system would eliminate all that.

    One administrator or “payer”—yes, a government supervised agency, would collect all health care fees and pay out all health care costs. In a single payer system, all hospitals, doctors and other health care providers would bill one entity for their services. Every US citizen would be covered. It’s been done successfully in most “civilized” countries. Why not here?

    US health care is in crisis, today. The system just isn’t working, for anybody, except, maybe the health insurance industry and their HMOs that are siphoning off whopping profits. But doctors aren’t happy. Patients are burdened more and more with increasing co-payments. Health care costs continue to skyrocket. And 47 million people remain uninsured. Sooner, if not later, the system will crash. Must we wait for that to happen?
    _______
    SEFleischman

    About author Stephen Fleischman, television writer-director-producer, spent thirty years in Network News at CBS and ABC, starting in 1953. In 1959, he participated in the formation of the renowned Murrow-Friendly "CBS Reports" series. In 1983, Fleischman won the prestigious Columbia University-Dupont Television Journalism Award. In 2004, he wrote his memoir. See: www.ARedintheHouse.com, E-mail: stevefl@comcast.net

    Worlds First Wheelchair Backflip! at Best Damn Links

    http://www.bestdamnlinks.com/out.cfm?link_id=10379

    Federal Agency Cleans Up Its Own Wikipedia Entry

    By: Ryan Grim
    January 27, 2007 05:55 PM EST

    url:
    PRINT ARTICLE EMAIL TO A FRIEND
    COMMENTDigg

    Wikipedia has come of age. The online user-created encyclopedia is now influential enough that the federal government feels the need to doctor it up.

    In late August, someone with an IP address that originated from the National Institutes of Health drastically edited the Wikipedia entry for the National Institute on Drug Abuse, which operates within NIH. Wikipedia determined the edit to be vandalism and automatically changed the definition back to the original. On Sept. 18, the NIH vandal returned, according to a history of the site's edits posted by Wikipedia. This time, the definition was gradually changed, presumably to avoid the vandalism detector.

    NIDA spokeswoman Dorie Hightower confirmed that her agency was behind the editing. She said in an e-mail that the definition was changed "to reflect the science."

    A little more than science-reflecting was done to the site. Gone first was the "Controversial research" section that included comments critical of NIDA. Next went the section on the NIDA-sponsored program that grows marijuana for research and medical purposes. The next slice of the federal editor's knife left all outside references on the cutting-room floor, replaced with links to government Web sites.

    Then the battle began. Over the next few weeks, Wikipedia users challenged the site's neutrality and took out the more egregious propaganda. Each time, the NIH editor would return. The fight left the article in tatters. Folks wondering what NIDA does now get four basic, non-controversial sentences followed by 10 links to federal Web sites. And at the bottom of the page is a plea from Wikipedia: "This article about a medical organization or association is a stub. You can help Wikipedia by expanding it."

    UPDATE: Wikipedia users have now returned much of the original content and added a section about NIDA's editorial relationship with its own definition. Here's the link.


    http://www.politico.com/news/stories/0107/2460.html

    Medical marijuana monopoly

    NIDA has a government granted monopoly on the production of medical marijuana for research purposes. In the past, the institute has refused to supply marijuana to researchers who had obtained all other necessary federal permits. Medical marijuana researchers and activists claim that NIDA, which is not supposed to be a regulatory organization, does not have the authority to effectively regulate who does and doesn't get to do research with medical marijuana. Jag Davies of MAPS writes in MAPS Bulletin:[9]

    Currently, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of research-grade marijuana, but no other Schedule I drug, that can be used in FDA-approved research. NIDA uses its monopoly power to obstruct research that conflicts with its vested interests. MAPS had two of its FDA-approved medical marijuana protocols rejected by NIDA, preventing the studies from taking place. MAPS has also been trying without success for almost four years to purchase 10 grams of marijuana from NIDA for research into the constituents of the vapor from marijuana vaporizers, a non-smoking drug delivery method that has already been used in one FDA-approved human study.

    NIDA administers a contract with the University of Mississippi to grow the nation's only licit cannabis crop for medical and research purposes,[10] including the Compassionate Investigational New Drug program. A Fast Company magazine article pointed out, "Based on the photographic evidence, NIDA's concoction of seeds, stems, and leaves more closely resembles dried cat brier than cannabis".[11] Medical marijuana researchers typically prefer to use high-potency marijuana, but NIDA's National Advisory Council on Drug Abuse has been reluctant to provide cannabis with high THC levels, citing safety concerns:[12]

    Most clinical studies have been conducted using cannabis cigarettes with a potency of 2-4% THC. However, it is anticipated that there will be requests for cannabis cigarettes with a higher potency or with other mixes of cannabinoids. For example, NIDA has received a request for cigarettes with an eight % potency. The subcommittee notes that very little is known about the clinical pharmacology of this higher potency. Thus, while NIDA research has provided a large body of literature related to the clinical pharmacology of -cannabis, research is still needed to establish the safety of new dosage forms and new formulations.

    Speaking before the National Advisory Council on Drug Abuse, Rob Kampia of the Marijuana Policy Project criticized NIDA for refusing to provide researcher Donald Abrams with marijuana for his studies, stating that "after nine months of delay, Dr. Leshner rejected Dr. Abrams' request for marijuana, on what we believe are political grounds that the FDA-approved protocol is inadequate".[13]

    [edit] Ricaurte's monkeys

    NIDA continues to provide funding to George Ricaurte, who in 2002 conducted a study that was widely touted as proving that MDMA caused dopaminergic neurotoxicity in monkeys.[14] His paper "Severe Dopaminergic Neurotoxicity in Primates After a Common Recreational Dose Regimen of MDMA ('Ecstasy')" in Science[15] was later retracted after it became clear that the monkeys had in fact been injected not with MDMA, but with methamphetamine.[16] A FOIA request was subsequently filed by MAPS to find out more about the research and NIDA's involvement in it.[17][18]

    [edit] NIDA and Wikipedia

    Treatment Art Card.
    Treatment Art Card.

    NIDA officials have edited the Wikipedia article about their organization to remove text and links critical of NIDA and add NIDA URLs and text from NIDA literature. The article history shows a single edit in late August 2006 and a number of edits during September 2006 by an anonymous editor with an IP address from within NIH. These edits have been reverted. In January 2007, NIDA spokeswoman Dorie Hightower verified that the editing was done by NIDA officials, and said it was done "to reflect the science."[19]

    http://en.wikipedia.org/wiki/National_Institute_on_Drug_Abuse

    Saturday, January 27, 2007

    DeGette Vows To Get Stem Cell Bill Past Bush Veto

    Jan 26, 2007 4:32 pm US/Mountain
    (AP) DENVER Colorado Democratic Rep. Diana DeGette vowed Friday to find a way to get the embryonic stem-cell research bill past another veto by President Bush, even if Democrats have to attach it to must-pass legislation.

    "He can do this the easy way, or he can do this the hard way," said DeGette, co-sponsor of the measure with Rep. Mike Castle, R-Del.

    The bill passed the House two weeks ago on a 253-174 vote, but DeGette said she doesn't have the 290 votes it would take to override a veto. The bill is now headed to the Senate, where it is expected to pass.

    Bush vetoed identical legislation last year and the White House has promised he would veto it again, saying the bill "would use federal taxpayer dollars to support and encourage the destruction of human life for research."

    DeGette said she offered to talk with Bush about the issue, but the White House said he wasn't available.

    The issue is whether taxpayer funds should underwrite research on stem cells taken from human embryos.

    Supporters, who include former first lady Nancy Reagan, say the research could lead to cures for diseases such as Alzheimer's, diabetes, cancer and Parkinson's.

    But it draws fierce opposition from abortion foes because the research typically involves the destruction of frozen embryos created for in vitro fertilization. Proponents say the research is done on embryos that would otherwise be discarded from fertility clinics anyway.

    DeGette said her measure got a boost in the last election when 14 incumbents who opposed the bill were defeated by candidates who support it.

    "What this said to me was this was a huge issue in the election," she said.

    Carbon Monoxide Protects Mice From Multiple Sclerosis

    Science Daily Multiple sclerosis (MS) is a chronic inflammatory disorder that causes degeneration of the nerves in the brain and spinal cord, leading to various symptoms including muscle weakness and pain. Most individuals with MS go through cycles of disease and remission, leading to the suggestion that there are regulatory mechanisms that counter the disease-causing inflammation.


    Using a mouse model of MS (known as EAE), researchers from the Gulbenkian Institute in Portugal show that increased expression of a protein known as HO-1, as well as administration of carbon monoxide, protect mice from disease.

    In the study, which appears online on January 25 in advance of publication in the February print issue of the Journal of Clinical Investigation, Miguel Soares and colleagues show that mice lacking HO-1 develop more severe EAE than wild-type mice. Conversely, in mice already suffering the symptoms of EAE, disease is reversed if HO-1 expression is induced.

    The function of HO-1 is to degrade excess heme (a component of many important cellular proteins) and one of the by-products of heme degradation is carbon monoxoide. Surprisingly, like the induction of HO-1 expression, administration of carbon monoxide to mice already suffering the symptoms of EAE decreased disease.

    The authors therefore suggest that modulating HO-1 expression or administering carbon monoxide might be useful therapeutic strategies to treat patients with MS.

    Note: This story has been adapted from a news release issued by Journal of Clinical Investigation.


    http://www.sciencedaily.com/releases/2007/01/070125190053.htm
    Carbon Monoxide Protects Mice From Multiple Sclerosis
    Science Daily (press release) - USA
    Science Daily — Multiple sclerosis (MS) is a chronic inflammatory disorder that causes degeneration of the nerves in the brain and spinal cord, ...

    Friday, January 26, 2007

    I am so sorry that the Tysabri did not work out for you. I am getting
    ready to take my third infusion and so far so good. I am waiting for
    that cure infusion!
    Take care,
    Smiles (f
    -----Original Message-----
    From:
    [mailto:] On Behalf Of
    Sent: Thursday, January 25, 2007 7:41 AM
    To:
    Subject: Re: Anyone out there taking Tysabri?

    --- In yahoogroups.com>
    @...>
    wrote:
    >Hi, all. I started taking tysabri three months ago. My
    frist dose in oct went fine, no problems. However the 2nd dose didn't
    go to hot. I started having back spasms and they thought i was just
    have a exberbation and it was just a fluke so they gave me morphine
    and some valium i.v. to go along with it.then my third dose i had
    just gotten 18cc of the medication and wham, it started agian, this
    time i couldn't breathe, threw up, back pains etc. so they pulled the
    i.v. then they followed up with morphine, valium and zofran. I spent
    the whole day in outpatient. Needless to say they pulled me off the
    tysabri program. they are now going to try avonox again. my doc
    thought i would be a good canadite for tysabri but it was a no go. I
    had another exberation this week, so now iam on i.v. predisone for
    another week.my left arm went into major spasms and is still kinda of
    use less. never had that happen before . just having rotten luck i
    guess. iam glad that the medication is going well for you.this is not
    disencourage anyone from taking the drug, just telling what happend
    to me. cause as everyone knows m.s. dont treat everyone the same.
    sorry for the spelling errors, not used to typng with one hand. lol.
    take care evryone. this is such a great group. i love all the info
    and input from everyone. iwill just hang in there and kept on truckin
    as usual. love to all

    I'm taking Tysabri
    just had my first infusion last week as the insurance took three
    months to approve it. I had taken 3 infusions before it was taken
    off the market and it was the best I had felt since being dx in
    2000. I was not afraid to go on it again.

    Expert Patient Beth Brophy celebrates Art Buchwald, a newspaper humorist who cheekily cheated death, noting, “I never realized dying was so much fun.”

    Incontinence Treatment: How to Get the Most Out of Your Visit
    Dr. Jennifer Sobol, incontinence expert, discusses how to get the most out of your first or follow-up visit with a urologist, when seeking incontinence treatment. She writes, "It never ceases to amaze me that a patient will come in complaining about incontinence, and yet he or she has very little knowledge of their own symptoms. Your doctor will want to know in what context do you leak urine. Is it with activity?" ... read more

    Ms stories

    Glad to hear you're doing good back on the Tysabri!

    XXXXXX:)
    ----- Original Message -----
    From: "XXXXXXXX" <XXXXXXX@kdsi.net>
    To: <XXXXXXXXXXX@yahoogroups.com>
    Sent: Wednesday, January 24, 2007 7:47 PM
    Subject: Re: XXXXXXXXXXXXX xxxxxx: Anyone out there taking Tysabri?

    > XXXXXXX,
    > I was on Betaseron since my diagnosis in 6/2000 I had an MRI in Nov. 2004
    > and it showed some active lesions which had not shown up before as I had
    > MRI's every year. The nuero said Betaserson was not working for me
    > anymore and I should go on Tysabri which I did in Dec. and had the 3
    > infusions before it was taken off the market. I then went on Rebief but
    > started having problems with Rebief like the welts (large red circles)
    > around the site where I injected and it would take up to 4 months for them
    > to go away. This started happening like last six -eight months ago. In
    > Sept I had the six month checkup with the nuero and told her about the
    > reactions to the Rebief shots. She asked if I wanted to go back on
    > Tysabri the main reason being my reaction to Rebief. It took a long time
    > to get approved by my insurance but I still had to be off Rebief for at
    > least 30 days before I could do the Tysabri infusion and since I was off
    > longer I was told that was a good thing. I felt great after the first
    > infusion and even feel I have more energy and look forward to the next
    > infusion in Feb.
    >
    > I had an MRI before starting Tysabri, blood work and they really put you
    > through a drill with the questions they must ask before the infusion. My
    > infusion is done at a Cancer Center in Kearney, NE which I have to drive
    > 100 miles one way we are use to driving long ways
    > to get places so it doesn't bother me. They told me the next infusion is
    > in 30 days but you could go up to 7 days before or 7 days after the 30
    > days which give you some flexibility in scheduling. I guess I've told you
    > more then you want to know. That is my Tysabri story.

    Teva Files Patent Infringement Complaints Regarding Sertraline ...
    Business Wire (press release) - San Francisco,CA,USA
    ... Neurontin®, Wellbutrin XL® and the effects of competition on Copaxone® sales, including as a result of the reintroduction of Tysabri® into the market, ...
    See all stories on this topic

    Merck Serono begins MS oral therapy trial
    Pharmaceutical Business Review Wed, 24 Jan 2007 6:03 PM PST
    Merck Serono has begun a phase II study that will evaluate two dose regimens of its oral formulation of cladribine when added to a new formulation of Rebif in multiple sclerosis patients.

    Researchers propose reason for severe side-effects of Northwick Park clinical trial
    EurekAlert! Thu, 25 Jan 2007 6:17 AM PST
    A possible reason why the Northwick Park clinical trial of the drug TGN1412 in the UK caused multiple organ failure in human volunteers is revealed in research presented today at a conference near Paris.

    Trigeminal neuralgia may be cause of facial pain
    The Biloxi Sun Herald Thu, 25 Jan 2007 1:07 AM PST
    Dear Dr. Sangani: For the past few months, I have been experiencing severe pain in my jaw area that usually only lasts a few minutes. It does not happen when I eat. It happens at anytime. What could be causing this?

    Chopping off protein puts immune cells into high gear
    EurekAlert! Wed, 24 Jan 2007 2:17 PM PST
    The complex task of launching a well-organized, effective immune system attack on specific targets is thrown into high gear when either of two specific enzymes chop a protein called LAG-3 off the immune cells leading that battle, according to investigators at St. Jude Children's Research Hospital.

    Medical cannabis is a blunt tool
    New Scientist Wed, 24 Jan 2007 11:15 AM PST
    Results of clinical trials of cannabis have been mixed and it now seems there are fundamental problems with how our bodies respond to the stuff

    The illness: Expensive insurance for serious health problems
    Independent Weekly Wed, 24 Jan 2007 1:05 PM PST
    The cure: Diving into the high-risk pool

    Thursday, January 25, 2007


    Merck Serono Has Initiated the ONWARD Study to Evaluate Oral Cladribine As Add-on Treatment for Multiple Sclerosis
    RedNova Wed, 24 Jan 2007 3:24 AM PST
    GENEVA, Switzerland, January 24 /PRNewswire-FirstCall/ -- Merck Serono (virt-x: SERO and NYSE: SRA) announced today that it has begun the ONWARD (Oral Cladribine Added ON To Rebif New Formulation in Patients With Active Relapsing Disease) Phase II study.

    Health & Beauty
    Belfast Telegraph Wed, 24 Jan 2007 3:36 AM PST
    The Tory leader, who has refused to answer media questions about whether he used drugs before entering politics, ruled out a wider legalisation of cannabis for recreational use.

    Michael J. Fox Foundation Funds Allon to Evaluate AL-108 for Parkinson’s Disease
    T-Net British Columbia Wed, 24 Jan 2007 8:48 AM PST
    Vancouver, BC, January 24, 2007--(T-Net)--Allon Therapeutics (TSX:NPC), The Neuro Protection Company, today announced it has received funding from The Michael J. Fox Foundation for Parkinson’s Research to evaluate the effectiveness of Allon’s lead drug AL-108 in pre-clinical models of Parkinson’s disease.

    Expanding Phase IV Trials and Use of Biomarkers for Personalized ...
    Pharmaceutical Processing - Rockaway,NJ,USA
    Just this past February, sales of the multiple sclerosis drug Tysabri were suspended after it was suspected of triggering a rare brain disease in three ...


    http://tinyurl.com/2gxetj

    Wednesday, January 24, 2007

    Ms stories

    I take it you were on Tysabri before it went off the market.
    My doctor was going to put me on it just before it went all the market.
    It came back on the market in June and I started buying infusions
    November 29. Friday will be my third in fusion Gary just this last
    month I can definitely tell that it is doing something very I have
    probably had MS longer than you have (12 years), but I am starting to
    see some positive results where I have tried all of the other MS drugs
    and none of them did anything :-(.
    Let me know when you get your first
    infusion, how long have you had MS? Good luck :-) smiles

    -----Original Message-----


    Went to neuro today and, and will be starting tysabri again in a few
    weeks. Would love to hear any advice,coments or your experiences.

    Thanks

    MS stories

    XXXXX,
    That's awesome!! I wish you the best with the study! I've said it
    before - I really admire people willing to take the risk of joining
    a study that will benefit the rest of us!
    Which vaccine study is it? Tovaxin or Neurovax?
    Good luck with everything! Please be sure to keep us updated on how
    things go for you, and how you feel during the whole thing.
    Rebecca

    xxxxxxx@xxxxxxxxx wrote

    They called me today and Dr. Freedman himself is running the
    study. I
    get mri's, bloodwork, cognitive testing and more done during the
    test
    of the once a month shot should I finish qualifications (My blood
    has
    to be able to produce some T-cell to partake inthe study) ...if it
    doesn't, I am taking part in a cognitive study for a new stimulant
    that
    is suppose to be specifically for MS patients with cognitive
    issues (my
    main prob).
    They are taking TWENTY tubes of blood plus a bag like I'm donating
    blood for the study, Yikes! Then I wash off the rebiff for 30
    days and
    start once a month vaccination shots from the vaccine made from my
    own
    T-cells.
    Wish me luck, I hope it works so we all have more hope for less
    shots!
    and better treatment!

    Tuesday, January 23, 2007

    Ms stories

    Headaches of all sorts are pretty common with MS and the quick sudden
    jabs of pain in your eye remind me of the cluster migraines that I
    get. So that could be why your doctor was asking about a history of
    headaches. My cluster migraines started at the base of my neck but
    were just like you describe-sudden, sharp, nearly unbearable pain,
    then gone in a flash. After a few months I started getting them
    elsewhere (behind my eye, around my temple, etc). It got to the point
    that I was having upwards of two dozen little cluster migraines per
    day. Eventually, my neuro put me on topomax and I haven't had any
    since. As to depression, well, it's understandable in anyone in a
    similar situation. But also a lot of the medications (I don't know if
    you're on any) for MS and its symptoms can cause depression or
    exacerbate anxiety problems. So, most likely, your doc was asking just
    so as to know how much of a problem some meds may be in light of
    personal history.

    I'd say mention everything to the doc. Even if it ends up being
    something normal it's good for the doc to know what's going on. And if
    you find yourself too selfconcious or uncomfortable telling the doctor
    things then that's a sign that this doctor might not be the best fit
    for you. You should always try to find someone that you feel okay
    about talking to (I learned that one the hard way).

    Good luck with your pain and numbness.

    MS stories

    I was 17 when I was diagnosed in 2000, I had it for a year or two before then cause I remember things that happened, I was just stupid and young and ignored what was going on because things would go back to normal. I was put on Avonex when I was first diagnosed and then after a year upped that to twice a week, that still didn't work well so after a year switched to Rebif.
    Had to quit college in 2003 so went on SSI (basically for the insurance part since I quit school I was no longer on my dad's). Had to start using a cane sometimes then in 2004 I got pregnant (not planned) so stopped the rebif and only used that again for about 6 months after my son was born cause I just kept going downhill to having to use a walker..
    Went and did solumdrol every month but stopped that cause it's to hard to deal with I get poked like 3 or 4 times till they find a vien, I don't eat anything while I'm on it and I'm basically dead on the couch till it's out. So stopped doing that (don't remember how long I did that for) Then I did Predisone everyday (my choice to try) and switched neuro's to one who deals with more progressive people he stopped me doing that and put me on 7.5 mg of methotrexate then upped it to 10 mg and to drink 1 gram of soulmedrol every month and then upped the methotrexate again to 12.5 mg a couple weeks ago and stopped the soulumedrol. And then also do 4o mg of baclofen for the stiffness.
    So right now me and my son still live with my parents and I am using a walker all the time (can't really do to a wheelchair cause there is no room in the house to manuver it but that way it keeps me walking and not giving up on that) But I don't really go out of house anyways cause my legs get so weak when I walk around a lot.
    Ways I manage it are to just rest my legs when I need to and to stay cool in the summer cause the heat really wears me down.

    XXXXXXXXXXXXX <xxxxxxxxxxxxxx@yahoo.com> wrote:
    Hey everyone, I don't post all the time but I just wanted to know how everyone was doing. I have a couple questions too.
    I was just wondering when were you all diagnosed and how is your MS progressing? What meds are you on if any? And other than meds how do you manage your MS?

    For me I got diagnosed May of 2005. So far it seems as though it's not progressing that fast, even though I can kind of sense when I'm going to hav ea flare up. I had numbness adn muscle weakness in May of '05 and that was it. Other that that I get bell's palsey every so often, and I get optic neutitis. I'm not on any meds as of right now. I'm waiting on my husband to switch jobs before I start. I'm still really scared about starting. Mainly because I'll have to take a shot everyday. My dr. wants me on copaxone. I don't really know how I manage my MS. I have 3 kids ages 5,3, and 2, a husband and 2 dogs. So it's hard to not get stressed out every now and again. But at the same time they are my support and the reason why I'm not going to let the MS rule my life.

    Well come on everyone, tell me yours!!

    Monday, January 22, 2007

    Phase I/II Tovaxin trial -- patients exhibited a relapse rate reduction of more than 90%

    11/13/2006
    Opexa Reports Third Quarter Financial Results

    THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today reported financial results for the three and nine months ended September 30, 2006. Highlights of the third quarter of 2006 and recent weeks include:

    Commenced Phase IIb Multiple Sclerosis trial for Tovaxin™; first patient dosed

    Reported positive data from Phase I/II Tovaxin trial -- patients exhibited a relapse rate reduction of more than 90%

    Listed on NASDAQ Global Market

    Initiated animal studies to test whether the Company’s proprietary adult human monocyte-derived pancreatic-like islet clusters are effective therapy for the diabetes mellitus indication.

    David McWilliams, chief executive officer, stated, “We have achieved several crucial milestones during this quarter that greatly enhanced both our investor profile and our clinical program. We made our NASDAQ debut in September, which was a long-standing corporate goal. In addition, we treated the first multiple sclerosis patient with Tovaxin in our Phase IIb trial. The data we reported from our Phase I/II trial were outstanding and we hope to replicate the impressive reduction in relapse rate in our Phase IIb trial. We expect to announce results from this trial in the first half of 2008.”

    Third Quarter Financial Results

    Opexa reported no revenues for the three months ended September 30, 2006 or in the comparable prior-year period. General and administrative expenses in the third quarter of 2006 were $1,430,507, compared with $2,324,228 in the third quarter of 2005. The decrease is due primarily to the decrease in non-cash stock-based compensation expense in the 2006 period. On January 1, 2006 Opexa adopted Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (“SFAS 123R”), which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors including stock options and restricted stock based on estimated fair values. The Company elected to adopt the modified prospective transition method as provided by SFAS 123R and, accordingly, prior-year results have not been restated.

    Research and development expenses were $2,113,878 in the 2006 third quarter, compared with $622,311 in the 2005 third quarter. The increase primarily was related to the initiation of the Phase IIb clinical trial, and a higher allocation of facilities and overhead costs to research and development due to increased development activities.

    Interest expense was $278 in the third quarter of 2006, compared with $1,385,234 in the prior year. Interest expense in the 2005 quarter was due to notes payable that were then outstanding, which subsequently were converted into equity in June 2005, resulting in acceleration of the amortization of the discount related to the notes.

    Interest income was $259,141 in the third quarter of 2006, compared with $31,565 in the prior year. The increase was due to the investment of the cash proceeds from the April 2006 offering in cash equivalent investments.

    The Company recognized a gain on derivative instruments of $2,418,078 in the quarter. This gain was a result of the net unrealized (non-cash) change in the fair value of derivative instrument liabilities related to certain warrants.

    Opexa reported a net loss for the third quarter of 2006 of $1,331,557, or $0.20 per share, compared with a net loss for the third quarter of 2005 of $4,726,848 or $2.31 per share. The decrease in net loss primarily was due to the decrease in non-cash stock-based compensation expense and interest expense and the gain on derivative instruments.

    The Company had cash and cash equivalents of $17,327,320 as of September 30, 2006, compared with $2,560,666 as of December 31, 2005. In April 2006 the Company raised approximately $23.0 million in gross proceeds through a private placement of units to institutional and other accredited investors.

    Year-to-Date Financial Results

    Opexa reported no revenues in the nine months ended September 30, 2006 or in the comparable prior-year period. General and administrative expenses for the first nine months of 2006 were $5,676,221, compared with $5,789,973 for the first nine months of 2005. The decrease is due primarily to the decrease in non-cash stock-based compensation expense in the 2006 period.

    Research and development expenses were $4,407,240 for the first nine months of 2006, compared with $1,877,787 for the first nine months of 2005. The increase primarily was related to the initiation of the Phase IIb clinical trial, and a higher allocation of facilities and overhead costs to research and development due to increased development activities.

    Interest expense was $891 for the first nine months of 2006, compared with $7,323,573 for the first nine months of 2005. Interest expense in the 2005 period was due to notes payable that were then outstanding, which subsequently were converted into equity in June 2005 resulting in acceleration of the amortization of the discount related to the notes.

    Interest income was $477,547 for the first nine months of 2006, compared with $50,474 for the first nine months of 2005. The increase was due to the investment of the cash proceeds from the April 2006 offering in cash equivalent investments.

    Opexa reported a net loss for the first nine months of 2006 of $11,777,735, or $2.38 per share, compared with a net loss for the first nine months of 2005 of $16,221,894, or $11.61 per share. The decrease in net loss primarily is due to the decrease in non-cash stock-based compensation expense and interest expense and the gain on derivative instruments.

    About Opexa Therapeutics

    Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company’s lead product, Tovaxin™, a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for type 1 diabetes. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    http://www.bcmtechnologies.com/ne_release.cfm?id=154&archive=y
    Wednesday, November 22, 2006
    The mystery of multiple sclerosis — and why Canadians have it most
    In Depth
    Health
    Last Updated November 1, 2006
    CBC News

    http://www.cbc.ca/news/background/health/ms.html
    Canadian women are more than three times more likely to get multiple sclerosis than men, according to a major study published in November 2006. Among those born in the 1930s, about two women contracted MS for every one man, at a ratio of 1.9 to 1. For those born in the 1980s, the incidence has grown to exceed 3.2 cases for every one case among men.

    Interactive

    MS rates around the world

    Why the sudden increase in the neurodegenerative disease, which attacks the brain and spinal cord, and can lead to paralysis and sometimes blindness?

    We don't know. We don't know what causes MS. We don't know what cures MS. The whys and wherefores of this mysterious disease have bedevilled scientists, health-care workers and victims for nearly 200 years.

    Recent speculation about the cause has ranged from genetics to environment to vitamin deficiencies to even the birth control pill.
    Canada has highest rate, especially in Prairies

    One thing we know for sure about MS is that Canada has the highest incidence of the disease in the world — a whopping 240 cases among every 100,000 people, according to a study by a University of Calgary team published in the journal Multiple Sclerosis in 2005.

    Health officials consider a country to have a "high" rate if they have more than 30 cases per 100,000.

    The incidence among the provinces varies, from a high of 340 cases for every 100,000 people in the Prairies to a low of 180 cases per 100,000 in Quebec.

    But overall, it works out about 1,000 Canadians being diagnosed each year with MS and more than 75,000 living with it. Those between ages 15 and 40 are most at risk. One out of every two Canadians know someone with MS.

    Another thing we know about MS is that people who live closest to the equator have the lowest incidence.

    However, that doesn't help explain why the disease is nearly absent among Canada's Inuit in the High Arctic and among indigenous people in North America and Australia, or why it is rarely found in Japan.
    Study suggests MS is environment-based, preventable

    The latest study on the rising incidence of women with MS was done by a team of researchers led by George Ebers, a professor of neurology at the University of Oxford. It appears in the November 2006 issue of the journal Lancet Neurology.

    The higher incidence of MS among women may not be bad news, according to the researchers — because it may help to shed light on what causes the disease.

    "What is going on here is something presumably that is preventable," said Ebers, who was the lead author of the study.

    "We just need to find out what it is in the environment. Because it has to be in the environment: your genes don't change over two generations, three generations."
    Others blame higher estrogen levels, less sunlight

    There has also been speculation that because MS is generally more prevalent in colder climates far north of the equator and far south of the equator, it may be due to vitamin D deficiencies.

    The body produces the vitamin in response to sunlight and so vitamin D levels fall off in colder countries and in winter because the sun's rays aren't intense enough.

    Because of the rising incidence of MS among women and because it seems to have started in the 1960s, many others have speculated that the cause may be connected to higher levels of the hormone estrogen due to the introduction of the birth control pill.

    But Ebers, who spent 22 years at the University of Western Ontario in London, Ont., before going to Oxford, rejects these factors as likely explanations.

    "I think one of the things one thinks of here is either that it's going to be something in the environment or it is going to be an environmental interaction with genes."