Latest Drugwonks' Blog

Plan B(S)

  • 08.02.2006

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.

Von step at a time

  • 08.01.2006

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…

Rocky I

  • 08.01.2006

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.

The Letter "B"

  • 07.31.2006

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.

Any questions?

The Letter "D"

  • 07.31.2006

One of things I miss about having kids under the age of 7 (mine are 19 and 15 so pray for me) is Sesame Street. I know, lots of “politically correct” issues, but even so it’s very educational and entertaining.

I especially liked the songs about the various letters of the alphabet. My favorite? “Letter B” sung to the tune of “Let it Be.” But I digress.

What I really want to talk about it the letter “D” — yes like in Part D.

“D,” in this context, does not and should not stand for “donut hole” — but that’s what the MSM thinks it means. What it actually stands for is “decision” — the decision to accept the responsibility for making smart health care choices. But that’s not a sexy news story and the media-savvy apostles proselytizing for Son of HillaryCare are doing a superb job feeding the frenzy with their anecdotes of woe.

Why are the anti Part D-ites focusing on the donut hole? Simple — because it paves the path for their ultimate message that “health care is complicated, so let Uncle Sam do all the work for you.”

Wrong! The consumer must be a partner in health care as well as health coverage — and not the junior partner either.

Those opting to focus on the donut hole today are the same people who, putting politics in front of the public health, worked tirelessly to frighten people away from signing up in the first place. One of their tactics was repeating the lie that there are no Part D insurance plans that provide for donut hole coverage.

Remember: “D” doesn’t stand for “donut hole”, it stands for “decisions” — and the right to have more than one.

Congratulations to Jeff Kindler on his elevation to the post of Chairman and CEO of Pfizer. We know Jeff and know him as a thoughtful person dedicated to the public health through a focus on medical research and development and smart public policy.

Good news for Pfizer. Good news for Pharma. Good news for the advancement of 21st century medicine.

The NYT’s Stephanie Saul hit another reporting low with her article on drug companies providing lunch to docs and their staff as part of their promotional pitch. For a minute, reading how all that pizza and Chinese food worked its way into the price of medicine, (probably half the price of the cost of Aricept right Stephanie) I thought it was a piece from the Onion. I mean, doctors who rely on the free food to pay for the lunch of staff because they can’t meet payroll and still get eggroll? Where did she find these people?

But then I realized she was serious, indeed in earnest. No dbout she was fed — pardon the pun — this story from the Soros funded group - No Free Lunch — a group of left wing docs who believe that physicians are corrupted by pens, coffee mugs and deli wraps.

So earnest that I guess she forgot to mention that the former BMS exmployee Kathleen Slattery-Moschkau she quotes extensively is also the writer-producer of a movie called “Side Effects” about her life as a sales rep. But I guess giving someone free publicity to promote their move without disclosing it even though that knowledge might shape your view of the article is ok while providing lunch to docs is unethical?

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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