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  • Posts Tagged ‘fda’

    Page 1 of 212»


    Washington Post opinion article on medical marijuana is an insult to our intelligence

    Tuesday, October 20th, 2009 at 6:41 pm | By: Radical Russ

    (Washington Post) The Justice Department says it’s backing off the prosecution of people who smoke pot or sell it in compliance with state laws that permit “medical marijuana.” Attorney General Eric Holder says “it will not be a priority to use federal resources to prosecute patients with serious illnesses or their caregivers.” Party hardy! I mean — let the healing begin!

    I don’t think the federal government should be spending a whole lot of time on small-time druggies, and I’m undecided about legalizing pot, which enjoys 44 percent support among the general public, according to a recent poll. Recreational use is not the wisest thing — and if my 12-year-old son is reading this, that means you! — but it’s no more harmful than other drugs (e.g., alcohol) and impossible to eradicate. On the other hand, I worry it’s a gateway to harder stuff. So I think we probably should have an open debate about decriminalization.

    The Institute of Medicine in 1999 and every peer-reviewed study since has concluded that there is no such thing as a “gateway effect” from marijuana to “harder stuff”.  What this writer, Charles Lane, wants is the government acting as parent to keep his 12-year-old off of pot by saying “don’t do it, it’s illegal”.  Which, by the way, has been a colossal failure; almost forty years into the War on (Certain American Citizens Using Non-Pharmaceutical, Non-Alcoholic, Tobacco-Free) Drugs™ and kids still say it is much easier to acquire weed than whiskey and blunts than beer.

    But it should be a real debate, about real decriminalization, and not clouded — pardon the expression — by hokum about “medical marijuana.” … I do not deny that for some people, including some terminal cancer patients and pain-wracked AIDS sufferers, marijuana is a blessed relief. Let ‘em smoke, I say, just as the Justice Department has usually ignored such cases since long before Holder spoke up. But if you believe there is any scientific evidence that smoked marijuana has the multiplicity of therapeutic uses that advocates claim — well, I’ve got a bag of oregano I’d like to sell you.

    There are over 17,000 peer-reviewed studies documenting the bona fide medical uses of cannabis and cannabinoids for a variety of conditions.  Would that count as enough “scientific evidence” for Charles Lane of the Washington Post?

    Read the rest of this entry by clicking here


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    FDA overrules recommendation to pull deadly Darvocet pain killers

    Wednesday, July 8th, 2009 at 11:20 am | By: Radical Russ

    WASHINGTON (AP) — The government is letting the painkillers Darvocet, Darvon and their generic cousins stay on the market but ordered stronger warnings against deadly overdoses on Tuesday.

    The Food and Drug Administration’s decision puts the U.S. in contrast to Britain — which banned the drugs several years ago, citing a trail of suicides and accidental overdoses — and Europe’s drug regulators, which just recommended that European Union countries do the same.

    Known generically as propoxyphene, the 50-year-old prescription drug is widely used in the U.S. even though doctors consider it a weak pain reliever. The consumer watchdog group Public Citizen had petitioned the FDA to ban it here, too, saying the small benefit didn’t justify a risk that was adding up to several hundred deaths a year. In January, the FDA’s scientific advisers narrowly agreed.

    But the FDA overruled its advisers Tuesday, at least for now. It ordered that a stern boxed warning be placed on the drug’s label and that patients soon start receiving a special pamphlet with every bottle that stresses the risk of taking too much.

    Yeah, what’s a few hundred deaths compared to Ely Lilly’s profits?  What do scientists know compared to pharmaceutical-industry-installed government bureaucrats, anyway?

    (Reuters) In his letter, (Congressman Henry) Waxman said a June 15, 2007 e-mail from then FDA Chief Counsel Sheldon Bradshaw showed he planned to forward a list of agency priorities to Deputy Secretary of Health and Human Services Tevi Troy. Both have ties to the pharmaceutical industry.

    The initiatives also appear to have bypassed normal regulatory channels so they could be implemented sooner, Waxman said.

    Before joining HHS, Troy worked for two think tanks with drug company ties, Waxman said, adding that Troy’s brother works as a lawyer for GlaxoSmithKline Plc.

    (Now, admittedly, that was the Bush Admin’s FDA.  But this Darvocet story makes me doubt the leadership of Obama’s new commissioner, Dr. Margaret Hamburg, especially when TIME Magazine noted:)

    Importantly, Hamburg is believed to be an acceptable choice to both the pharmaceutical industry and consumer advocates, a narrow tightrope any nominee must walk to win Senate confirmation.

    Why does the head of the agency charged with regulating the pharmaceutical industry need to be acceptable to the industry she’s regulating?  Are we going to ask death row inmates their opinions of the new warden?

    This is the same FDA that prohibitionists keep telling us has never and would never approve cannabis for medicinal purposes because it’s too gosh darn dangerous.  Hey, what if we package it with a special pamphlet and a stern boxed warning on the baggie: “Warning: taking too much cannabis may lead to the risk of overeating Cheetos, enjoying jam bands, and fits of giggling.”

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    Stash for Wed, Jul 1, 2009

    Wednesday, July 1st, 2009 at 7:00 pm | By: Radical Russ

    Download Link: Secret Stash - Register to access

    Audio clip: Adobe Flash Player (version 9 or above) is required to play this audio clip. Download the latest version here. You also need to have JavaScript enabled in your browser.

    Hemp Headlines

    1. The Importance of Permitting Consumers the Right to Cultivate Marijuana for Personal Use
    2. FDA recommends lowering dosages of acetominophen, “the leading cause of liver failure”
    3. Congress lifts “Barr Amendments” forbidding DC from medical marijuana and decriminalization
    4. Annual Ontario Hempfest festivities will cease this year due to police harassment

    Cannabis Science with Dr. Mitch Earleywine

    • A look at the human relationship with cannabis throughout history

    Daily Toker Tunes by Marijuana Music Awards . com

    NORML Newsmakers

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    FDA recommends lowering dosages of acetominophen, “the leading cause of liver failure”

    Tuesday, June 30th, 2009 at 8:20 pm | By: Radical Russ

    (Yahoo! News) ADELPHI, Md. – Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.

    A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.

    The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.

    Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.

    Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.

    Gosh, that doesn’t make any sense.  I looked all over the federal drug schedules and couldn’t find acetominophen.  It’s an over-the-counter drug, so any adult can just go in and buy as much as they want off of a store shelf (maybe even kids, too; I can’t recall any prohibition against it).  Yet it is estimated to cause 2,600 hospitalizations and 450 deaths per year.  It is also very bad for your liver:

    But some people are more susceptible to acetaminophen toxicity and can experience liver damage even at the recommended dose. A study by the U.S. Food and Drug Administration (FDA) showed that about 20% of people with acetaminophen-related liver toxicity had taken less than the recommended daily amount. For other people, a dangerous dose is not much higher than the recommended dose—that is, the “window” between a therapeutic dose and a toxic dose is smaller for acetaminophen than it is for many other drugs.

    Some experts also believe that taking acetaminophen for several days in a row may cause a dangerous build-up of the drug in the body. Acetaminophen is more likely to cause liver toxicity at near normal doses when used by people who drink alcohol. In fact, people who drink regularly may be more prone to liver damage even if they do not consume alcohol and acetaminophen at the same time. There appears to be added risk even if people take acetaminophen a few hours, or in some cases longer, before or after drinking.

    Gee whiz, a drug that has medical value and an accepted safe use under medical supervision, yet is hepatoxic and sometimes fatal, why, you’d think that drug would be on the Controlled Substances list and require a doctor’s prescription, wouldn’t you?  Aha, but you’ve missed the parts that mention “potential for abuse” and “psychological dependence”.  Since acetominophen doesn’t get you high or addicted, the government doesn’t care so much about controlling your access to it, even if more people overdose on it than on alcohol in a given year.

    But if it is a natural unprocessed herb gets you high, it doesn’t matter that it has never killed anyone, it’s safe to use without medical supervision, and it has numerous medical applications, it’s going up on Schedule I and if you’re caught with it, you’re going to jail.  And if that gives you a splitting headache, the jailers will be glad to get you a Tylenol.

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    Mother Jones explains how the Drug Czar is mandates to lie about marijuana

    Tuesday, June 30th, 2009 at 11:20 am | By: Radical Russ

    (Mother Jones) AMONG OUR LEADERS in Washington, who’s been the biggest liar? There are all too many contenders, yet one is so floridly surreal that he deserves special attention. Nope, it’s not Dick Cheney or Alberto Gonzales or John Yoo. It’s a trusted authority figure who’s lied for 11 years now, no matter which party held sway. (Nope, it’s not Alan Greenspan.) This liar didn’t end-run Congress, or bully it, or have its surreptitious blessing at the time only to face its indignation later. No, this liar was ordered by Congress to lie—as a prerequisite for holding the job.

    Give up? It’s the head of the Office of National Drug Control Policy (ONDCP), a.k.a. the drug czar, who in 1998 was mandated by Congress to oppose legislation that would legalize, decriminalize, or medicalize marijuana, or redirect anti-trafficking funding into treatment. And the drug czar has also—here’s where the lying comes in—been prohibited from funding research that might give credence to any of the above. These provisions were crafted by Dennis Hastert (R-Ill.) and Bob Barr (R-Ga.) and pushed for by then-czar Barry McCaffrey, best remembered for being somewhat comically obsessed with the evils of medical marijuana. A few Dems complained that the bill, which set “hard targets” of an 80 percent drop in the availability of drugs, a 60 percent decrease in street purity, and a 50 percent reduction in drug-related crime and ER visits, all by 2004—whoops!—was “simplistic” and “designed to achieve political advantage.” Though the vote count was not recorded for history, it got enough bipartisan support to be signed into law by Bill “Didn’t Inhale” Clinton.

    But then, the drug war has never been about facts—about, dare we say, soberly weighing which policies might alleviate suffering, save taxpayers money, rob the cartels of revenue. Instead, we’ve been stuck in a cycle of prohibition, failure, and counterfactual claims of success. (To wit: Since 1998, the ONDCP has spent $1.4 billion on youth anti-pot ads. It also spent $43 million to study their effectiveness. When the study found that kids who’ve seen the ads are more likely to smoke pot, the ONDCP buried the evidence, choosing to spend hundreds of millions more on the counterproductive ads.)

    Like Stasher Jillian wrote: “the ONDCP is required by law to forever oppose legalization, and when they do our legislators say ‘look, the ONDCP opposes legalization so it must be a bad thing’, so they continue to vote against it.”  Yup, when it comes to legalizing marijuana, our three branches of government are quick to point fingers.  The Judicial branch, when we take medical marijuana to the Supreme Court, points to the Legislative and says, “Congress has the power to change it”.  When we look to the Congress, they point to the Executive and say, “The ONDCP, NIDA, and FDA all say medical marijuana is bad, so we can’t change it.”  When we appeal to the President and the Drug Czar, they point to the Judicial and say “The Supreme Court ruled we can control marijuana,” and they point to the Legislative and say, “and Congress has mandated that we do so.”

    Regarding medical marijuana, there is no other policy (save perhaps foreign policy toward Israel) where the American people have have such overwhelming support for one side, regardless of party affiliation, and the leaders in Washington have the complete opposite stance, again, regardless of party affiliation.  And you know – you just know – that if any Congressman’s spouse was stricken with cancer, that regardless of whether they serve in a medical marijuana state or have ever voted against medical marijuana, one of their aides would magically find a joint or two to get the spouse through chemo.

    Because it doesn’t matter if 70% of the American people support medical marijuana.  100% of Merck, Pfizer, Bristol-Myers-Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, and others don’t.

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    Two San Antonio women die from Fentanyl patches

    Tuesday, June 30th, 2009 at 10:20 am | By: Radical Russ

    (WOAI.com) SAN ANTONIO — Controversy is brewing over a patch used for pain relief. At least two people in San Antonio have died after using the Fentanyl patch, and their families are blaming what they say is a defect.

    Like most medicinal patches, Fentanyl is used by peeling off a sticky side and placing it against the skin of a patient. The patch is left on the skin for up to 72 hours and is supposed to provide the exact amount of medication needed.

    However, the families of two San Antonio women who died say the patch they were prescribed to relieve their pain ended up killing them.

    According to lawsuits filed by family members, both women suffered chronic pain. So, their doctors suggested Fentanyl patches.

    Fentanyl is stronger than morphine. When it is applied to the skin, it then delivers a certain amount of Fentanyl into the patient.

    While wearing the patches, Donna Singleton and Ellen Burks died. Their families say both suffered an overdose of Fentanyl because the patches were defective.

    Similar patches have been recalled before because a cut along the side of the patch allowed too much Fentanyl to leak and cause a possible overdose.

    Wait a minute, didn’t the Food & Drug Administration approve the use of these Fentanyl patches?  Why, doesn’t that mean it’s safe?  We know for sure that the FDA wouldn’t let people stick a patch on their body loaded with a Schedule II drug if it weren’t safe, even if this Fentanyl is just one isomer short of being Schedule I “China White” heroin.

    We know this because they protect us from that evil Schedule I medical marijuana that never killed anybody in 5,000 years.


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    Liberal Thinking by Congressman Ron Paul

    Friday, June 19th, 2009 at 10:20 am | By: Dudemaster

    The Honorable Congressman, Dr. Ron Paul (R-TX), is one of my favorite politicians. Although I don’t always agree with him, he speaks only the truth. He wrote this article for the Free Liberal, and it is quite profound.

    Moving Towards Tobacco Prohibition

    Last week, another bill was passed and signed into law that takes more of our freedoms and violates the Constitution of the United States. It was, of course, done for the sake of the children, and in the name of the health of the citizenry. It’s always the case that when your liberty is seized, it is seized for your own good. Such is the condescension of Washington.

    The Family Smoking Prevention and Tobacco Control Act will give sweeping new powers over tobacco to the FDA. It will require everyone engaged in manufacturing, preparing, compounding, or processing tobacco to register with the FDA and be subjected to FDA inspections, which is yet another violation of the Fourth Amendment. It violates the First Amendment by allowing the FDA to restrict tobacco advertising in multiple ways, as well as an outright ban on advertising any cigarettes as light, mild or low-tar. The FDA will have the power of pre-market reviews of all new tobacco products, and will impose new user fees, meaning taxes, on manufacturers and importers of tobacco products. It will even regulate the amount of nicotine in cigarettes.

    My objections to the bill are not an endorsement of tobacco. As a physician I understand the adverse health effects of this bad habit. And that is exactly how smoking should be treated – as a bad habit and a personal choice. The way to combat poor choices is through education and information. Other than ensuring that tobacco companies do not engage in force or fraud to market their products, the federal government needs to stay out of the health habits of free people. Regulations for children should be at the state level. Unfortunately, government is using its already overly intrusive financial and regulatory roles in healthcare to establish a justifiable interest in intervening in your personal lifestyle choices as well. We all need to anticipate the level of health freedom that will remain once government manages all health care in this country.

    Actions in Congress such as this tobacco bill are especially disconcerting after we thought we were beginning to see some progress in drawing down the wrong-headed and failed war on drugs. A majority of Americans now think marijuana should be legal, taxed and regulated, according to a recent Zogby poll and over 70 percent are in favor of allowing medicinal use of marijuana. Bills like this take us down exactly the wrong path. Instead of gaining more freedom with marijuana, we are moving closer to prohibiting tobacco. Our prisons are already bursting with non-violent drug offenders. How long will it be before a black market in tobacco fills the prisons with non-violent cigarette smokers?

    Hemp and tobacco were staple crops for our founding fathers when our country was new. It is baffling to see how far removed from real freedom this country has become since then. Hemp, even for industrial uses, of which there are many, is illegal to grow at all. Now tobacco will have more layers of bureaucracy and interference piled on top of it. In this economy it is extremely upsetting to see this additional squeeze put on an entire industry. One has to wonder how many smaller farmers will be forced out of business because of this bill.

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    House Passes Measure to Let FDA Regulate Tobacco

    Thursday, April 2nd, 2009 at 2:53 pm | By: Radical Russ

    The House voted Thursday to grant the Food and Drug Administration sweeping powers to regulate the production and marketing of tobacco products.

    Under the bill (HR 1256), which passed 298-112, the FDA would be able to regulate nicotine levels, and makers of tobacco products would face tough new marketing and advertising restrictions.

    The bill now goes to the Senate, where lawmakers are expected to face intense lobbying from the White House to clear it.

    Supporters say the measure faces its best chance of becoming law since a massive effort to regulate tobacco and codify a landmark settlement with the tobacco industry collapsed in the Senate a decade ago.

    Republicans said it defies common sense to ask the FDA, which approves products if they are proven to be safe and effective, to regulate nicotine.

    “The last thing we should be doing is forcing the FDA to regulate an inherently dangerous product and carrying out a mission that is counter to its culture,” said Buyer during the debate.

    via House Passes Measure to Let FDA Regulate Tobacco.

    Excuse me, is this the same FDA that won’t approve a product that is proven to be safe and effective?

    If this bill passes and the FDA begins regulating tobacco, then it becomes even more absurd for them not to approve cannabis.  Of course, they cannot while cannabis is still Schedule I, a designation meaning that the drug has no accepted medical value in the United States, despite thirteen states in the United States accepting the medical value of cannabis.

    The DEA, Attorney General, or President would have to change the designation of cannabis from Schedule I to at least Schedule II (or completely de-schedule it, as logic would dictate), which they can do as an executive measure.  It need not be approved by Congress or the courts.

    That would be the Drug Enforcement Administration, which is also charged with enforcing the laws against the hemp that is not a drug, or the Attorney General, who once fought for five-year mandatory minimums for marijuana sales in DC, or the President who “inhaled, frequently, that was the point” and now can’t stop giggling about it.

    And they are the ones who wonder what the hell we’ve been smoking.

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    Addiction Science Network’s Position Statement on Medical Marijuana

    Monday, March 9th, 2009 at 8:48 am | By: Radical Russ

    The ASNet specifically:

    (1.) endorses the medicinal use of marijuana for compassionate use including non-terminal but chronic illnesses such as multiple sclerosis, fibromyalgia, and other conditions involving neuropathic pain unresponsiveness to conventional medications,

    (2.) firmly disagrees with the National Institute on Drug Abuse (NIDA), the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and other government agencies that purport marijuana to be a highly addictive substance similar to cocaine and heroin (in fact, we consider this assertion to be particularly irresponsible and call upon these government agencies to soften their rhetoric regarding marijuana and to recognize its actual status as a ‘soft drug’),

    (3.) supports the decriminalization of marijuana and applauds progressive state legislative bodies such as that seen in our home state of New York who have already de facto decriminalized marijuana, and

    (4.) while not advocating the recreational use of marijuana presently withholds opinion on this popular activity.

    via Position Statement on Medical Marijuana.

    It’s always amazed me that anyone who works in addiction could possibly put cannabis in the same club as heroin.  Marijuana is about as addictive as coffee and only about 9% of marijuana smokers ever develop a clinical dependence.

    Or let me put it this way – as a twelve year old, I watched my dad kick alcohol and speed cold turkey, sweating and puking and twitching and hallucinating in a single wide trailer over the span of three horrendous weeks… I’ve smoked a lot of pot in my life, but lack of bud never put me through anything remotely close to that.

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    House Bill Expected on FDA Control of Tobacco

    Monday, March 2nd, 2009 at 9:17 pm | By: MrSpof

    Landmark legislation to put tobacco under control of the Food and Drug Administration will surface in Congress next Wednesday and may be passed along to the president early this year.

    The House Committee on Energy and Commerce is expected to vote on the legislation on Wednesday, a spokeswoman, Karen Lightfoot, said Friday.

    The legislation would set up a new office in the F.D.A., financed by industry fees, to focus on tobacco. It would allow further restraints on sales and marketing to young people, including stronger warning labels with graphic depictions of smoking-related illnesses.

    via – The New York Times “House Bill Expected on F.D.A. Control of Tobacco” 2/28/09

    There’s nothing wrong with that, right? FDA oversight has worked well for most of our food and drugs barring small ‘oopsies’ like peanut butter and Seroquel (OK, a bunch more, too, but I have an article word limit). The problem lays with the hypocrisy shown by the FDA when you compare what they say about medical marijuana.

    (… marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision). Furthermore, there is currently sound evidence that smoked marijuana is harmful. via – US FDA “Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine”

    Yet the FDA is willing to control tobacco which actually has the characteristics of their quoted report and is a proven killer of more than 418,000 Americans every year vs 0 deaths from marijuana. The bill has language specifically allowing for “further restraints on sales and marketing to young people”. Isn’t this exactly what marijuana law reformers want when our drug of choice is legalized?


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    Latest on Sat, 04:16 am

    RevRayGreen: MASS TWEET THIS -@ChuckGrassley Truth is Chuck you follow Nixon's CSA full of reefer sadness. btw Chuck, Marijuana is not a drug.

    RevRayGreen: @ChuckGrassley http://bit.ly/55Ejsi Truth is Chuck you follow Nixon's CSA full of reefer madness. btw Chuck, Marijuana is not a drug.

    SneakerPimp: one last thing Puff puff pass to any one who wants it

    SneakerPimp: i wanna here about the imminent MiniSpof :clap: :2thumbs: :cool: :mrgreen: sounds like time for some :cake:

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    SneakerPimp: oh yea also wake n bake

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    WakeUpDead: @Russ, I dont think that wireless is going to work out for the show, it was choppy and studdered just like last week. Hardline may be the only way. Puff [...]

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    Radical Russ: OK, test over. Sorry. Only needed a half hour. Be back tomorrow afternoon.

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