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From the AP Wire:
Vermont Gov. Jim Douglas and his counterparts in three others states petitioned federal health officials Thursday to issue long-delayed guidelines on the production of generic versions of insulin and human growth hormone.
“We’re tired of waiting for the FDA to act,” said Douglas, speaking at a news conference in Montpelier, Vt. “It’s time for the federal government to end its foot-dragging and put the interests of Americans who need access to less expensive medications ahead of the interests of the pharmaceutical industry.”
Douglas and the others said there were no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted.
Well, um, actually there are quite a few very thorny scientific questions and I’m sure the FDA would be more than willing to brief Governor Douglas, et al.
(Note to Governor’s staff: If you need the FDA’s phone number, please email me at firstname.lastname@example.org.)
Also — when it comes to follow-on biologics (there really can never be a truly generic biologic) there are also legislative questions. To that end I recommend that Governor Douglas call his congressional delegation. And how hard could that be? After all, it’s Vermont. There are two senators and only one representative.
I pondered this question in light of Mel Gibson’s anti-Semitic rant at the LA cop while deep under the influence of distilled spirits. Can we blame Gibson’s views on alcohol? You can say a lot of things when you are drunk, but the phrase “The Jews start all the wars” is not exactly one that leaps to mind in people who are plastered. Then again, Michael Moore called Israel part of the true axis of evil and he was stone sober, though overweight when he said that…No one seems to care.
Which raises an interesting question, when will someone begin to blame hateful outbursts on Ambien? It makes statistical sense. And according the Washington Post ,which has made coverage of Ambien a nice little hobby, it seems to cause everything else. Ambien, we are told, caused Patrick Kennedy to smash his car up, causes sleepwalking, shoplifting, midnight snacking, etc., etc.
Or does it. After all, sleepwalking, car crashups, and shoplifting were around before Ambien. So was the drug and alcohol addition of people that often take these medications or abuse them. But even with that, just how much of problem is this so-called Ambien epidemic? The folks at http://www.blogcritics.org did the math in a March 14, 2006 posting:
In 2004, over 24 million prescriptions for Ambien were written. Let’s say that each contained 30 pills. That’s 740 million times people took this sinister drug in 2004. Tinmothy Morgenthaler, a Mayo Clinic researcher, reported five cases fo sleepwalking in 2002. Nineteen cases were reported by one center last year. Since 1997, a whopping 207 sleepwalking incidents have been reported, most of which physicians can’t link to Ambien. In fact, only 48 have been linked to this killer drug.
It’s well known that adverse incidents are under-reported, so let’s assume a factor of 100. That is, there are 100 times more incidents that are reported. Okay, we get out our calculator and multipy 48 incidents times 100. Wait a minute. Got it, that’s 4800 incidents over, say, 8 years or 600 a year. Wow! No wonder it got banner headlines. But wait. The drug is used 740 million times a year, which means your odds of sleepwalking from using the drug are 0.00008% or something like 1/80,000th of a percent. Another way of thinking about it is that if you take the drug 80,000 times, you have a 1% chance of sleepwalking.
Blame Ambien for anti-Semitic outbursts? Might as well blame the Jews for sleepwalking.
Lots of news reports today by the MSM (New York Times, Washington Post, etc.) on the Lipitor patent issue. Zero coverage on the news that the governments of Great Britain and Canada have alerted their citizens to another case of counterfeit Lipitor.
Serious? Consider the following statement (as responsibly reported in the Times of London), “Experts are becoming increasingly concerned that criminal networks are exploiting the market in statins, which are taken by millions of people to lower cholesterol.” The Times reports that there are broader concerns about the criminal network linked to the men arrested.
In a plan published last week by the Medicines and Healthcare products Regulatory Agency (MHRA), Kent Woods, its chief executive, outlined significant concerns about counterfeit products and internet sales. Describing the “increased threat across the world,” he said that international relationships needed to be developed and “as much disruption as possible created to illegal and unsafe trade.”
To that end, I am posting a copy of “Coincidence of Crisis,” (the new book on how to accomplish precisely that goal — edited by me and published by the Stockholm Network) to Mr. Woods today.
(BTW, if you would like a copy of “Coincidence or Crisis” it is available at www.cmpi.org as a download. If you would like a hard copy, please e-mail me at email@example.com.)
Our friends in the Great White North are also concerned. From Ottawa comes the news that Health Canada is informing Canadians about this same case, reminding their citizens that …
“Counterfeit drugs may contain the incorrect dose, the wrong ingredients, dangerous additives, or no active ingredients at all, which could result in potentially serious health risks to patients. Even if these drugs do not
harm you directly or immediately, your condition may get worse without effective treatment.”
And I’m sure that sounds as frightening in French.
Why is Health Canada so concerned about a UK counterfeits problem? Because it’s an international problem. Because Canadian Internet pharmacies brazenly (and illegally) import drugs from all across Europe.
Oh, sure — these profiteers masquerading as pharmacists will tell you that they only import from the UK — but, because of parallel trade (what we in the US call “re-importation”), upwards of 20% (one-in-five) of all drugs sold in the UK come from other places within the EU like Greece, Portugal, Latvia, Estonia, Malta and Cyprus. And according to the Treaty of Rome, parallel trade is completely legal and Articles 30 and 36 prohibit manufacturers from managing their European supply chains in their own or patients’ interests.
In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Baton Rouge) is impossible.
And speaking of Baton Rouge, this latest trans-Atlantic counterfeits case should serve as a wake-up call to those who don’t think that US Customs has to worry about “Canadian” drugs coming into the US via the mail.
That’s a dangerous dance. Let’s call it “the Vitterbug Shuffle.”
Here’s where we at drugwonks try to impose a little logic on the rhetoric of pols on the Plan B issue to underscore once again that whatever you think about its availability (and I think it should be out there) this is not about public health or science or consistency.
Tom Harkin wants to know why Plan B should be restricted to people 18 years of age and older while it can be purchased OTC in Europe by anyone. I guess that means Harkin was on joking when he supporting restircting the sale of pseudoephedrine products to minors cumulative amount of pseudoephedrine purchased per month to 7.5 grams. Plan B will join Sudafed and other PSE containing pills behind the counter at drug stores. Why one and not the other Senator? (PS. The practice has had no effect on cold medication sales.)
Senator Christopher Dodd (and Grassley) talks about restoring scientific integrity to the FDA but then he entrusts David Graham to help write his legislation and on withdrawing Ketek despite a scientific consensus that this is a badly needed medicine.
Hillary Clinton claims that getting drug companies to work with pharmacists to limit the distribution of Plan B to minors is akin to Clinton likened that demand to holding the distillers of alcoholic beverages responsible for bartenders who serve underage drinkers. Uh, but we already do Senator. Ditto for tobacco. Remember the multi-billion tobacco settlement your administration helped engineer along with the then FDA commissioner who called for tobacco companies to restrict their marketing practices and work with retailers to cut down on kids smoking. What about the vaccine companies sued by trial attorneys not because they did anything wrong but because they have deeper pockets than some lonely doc?
Plan B politics is simply political BS.
Free Andy now!
The news coverage of yesterday’s H.E.L.P. committee hearing on Dr. von Escehnbach’s confirmation as FDA Commissioner focused almost exclusively (yep, you guessed it) on Plan B.
Is there anything else? Not according to the MSM and certain pols and pundits.
Is there anything else?
You mean like, perhaps, moving forward in the war against disease? Perhaps new ways to accelerate the approval of life-saving cancer medications, advances in the treatment of Alzheimer’s Disease, better more robust ways to understand and use biomarkers and innovative biomedical technologies to allow the safer, more targeted use of existing drugs?
Is there anything else?
Here’s what Andy had to say in his opening remarks:
“A few weeks ago I spoke with a young mother who happened to be celebrating her daughter’s birthday when I returned her call.
She shared with me that she had a tumor for which she had already been treated with surgery and chemotherapy but the tumor was growing and threatening her life and her hope of being there for her daughter’s next birthday. The question she wanted to ask me was IS THERE ANYTHING ELSE. Senators and Members of the Committee, millions of people are asking if there is anything else. Anything else for cancer, Alzheimer’s, AIDS, diabetes, Avian flu — anything else to protect our food supply, improve nutrition, alleviate obesity, keep our animals healthy and cosmetics safe. The fact is that there cannot be anything else without this FDA — a modern, efficient and effective FDA.”
So, indeed, there is something else. And that something else is advancing the public health.
Oh — and by the way — all of the members of the committee agree that Andy is highly qualified. I guess that’s not enough for a speedy confirmation anymore. Or is it?
Time for a vote. Anything less is holding the public health hostage for political reasons.
Andy was dandy today in front of the H.E.L.P. committee. If you’re into reading tea leaves, consider the fair and equitable demeanor of Senator Kennedy. What about the Murray/Clinton hold? It’s looking more self-serving and silly by the minute.
According to Leo Rosten in the Joys of Yiddish, a mensch (or mentch) is “someone to admire and emulate, someone of noble character. The key to being “a real mensch” is nothing less than character, rectitude, dignity, a sense of what is right, responsible, decorous.”
Some have carped that Andy von Eschenbach stirred the pot too much and broke too much china at his stint over at NCI. The same critics complained that as FDA commissioner he was too low key and spent too much of his limited time in pubilc simply saying the same things.
But if you are someone who has survived three forms of cancer your time horizon and your reaction to the cookie cutter criticisms of others can be quite different. You go at your own pace even as you are driven to complete a mission and engage others. You do it by not berating, bleating or browbeating. You are tough but you don’t show it by bulling others or throwing your weight around.
That’s a mensch and that’s Andy von Eschenbach. That was the person who testified in between long rants and howls that comprise the latest installment of the reality TV show, Hillary Knows Best, starring Sens. Hillary Clinton and Patty Murray. This week, as with last week and the week before and week before and week before and week before was an encore presentation of the show on Plan B and WHY THEIR HOLD ON THE FDA NOMINATION IS SAVING SCIENCE.
He was patient and concise, explaining to Senator Dodd why in an era when the science of drug development will allow us to determine that a drug most effective for a patient is also the safest we should seek to integrate safety and efficacy data, not chop it up into two agencie. (Dodd: “Yeah I understand that. But when a drug is on the market, shouldn’t a separate agency from the division that approved the drug pull it from the market….”) He invoked the Critical Path and the importance of transparency. But he also insisted that scientists who disagree with the consensus not claim that the majority is bought and sold or wrong and that they are right and do so by running to the media or some media-hungry Senator. He didn’t say that exactly. Rather he insisted on a standard of conduct, dignified, decorous and responsible. And he demonstrated that standard, behaving in stark contrast to many of the howling handful ho skewered him (Senator Kennedy being a dignified exception) and to those who have made book on counting out Andy in the past.
Andy von Mencshenbach….maybe he can change his name when he gets confirmed…
In a recent op-ed appearing in The Hill (“Medicare’s elephant in the room: The rising cost of pharmaceuticals”), Senator Jay Rockefeller has come out full-bore in favor of negating Federal non-interference for Medicare Part D. It’s chock full of errors. One example:
“In recent years, high-quality, affordable healthcare has eluded consumers, and the No. 1 culprit is skyrocketing prescription-drug costs.”
Nope. Imagine American health care spending as a dollar bill divided into a hundred pennies. How many pennies do you think represent spending on prescription drugs? 60? 80? Wrong. 10.5. The rest (otherwise known as 85%) represent everything else — from physician services (21.9%) to hospital care (31.3%). And, by the way, the 10.5% of US health care costs spent on Rx drugs includes both generics and on-patent pharmaceuticals.
What’s a better bargain: time spent in the hospital, or drugs that keep Americans healthy and productive? The answer is clear. Fewer cents make the most sense.
So why is this blog entry called “Rocky I?” Unfortunately it’s because I don’t think it’ll be my first and final comment on Senator Rockefeller’s newest issue.
Here is the response of Sens. Murry and Clinton on the news that Plan B might be available without an prescription to women 18 yrs and older:
“Today’s announcement is nothing more than another delay tactic. The FDA continues to shirk its duty to serve as an independent agency dedicated to no other goal than the promotion of sound science and the well-being of the American people,”
As Peter and I have asked before: Denying the FDA a permanent commissioner over Plan B advances the public health exactly how? Placing a hold on a FDA appointment because of condom labeling or having a Senate commitee review scientific decisions promotes sound science in what specific ways?
We look forward to the day when a member of congress places a hold on a nomination or pledges to boost FDA to dramatize the lack of effective treatments for Alzheimer’s or childhood cancers or taks a stroll over to HHS to thank FDA employees for approving a lifesaving treatment. Until then, the sounds of silence about how the FDA is shirking sound science from the Beltway blowhards would be a relief and might even reduce the oppresive humidty.
Like I said below — Letter B/Let it Be.
Here’s the headline:
FDA Announces Framework for Moving Emergency Contraception Medication to Over-the-Counter Status
And here’s the statement:
FDA announced today it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option. The Agency and the Sponsor will discuss the Sponsor’s proposed restricted distribution and risk management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older. FDA and the Sponsor have agreed to meet immediately to discuss the approvability of the Sponsor’s amended application and the framework by which this medicine can be made available over-the-counter. The Agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks.
This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor’s amended application. Foremost in the Agency’s concerns is to establish a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use. The Acting Commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step in moving the Agency’s broad and critical agenda forward.