Latest Drugwonks' Blog

New Hearing for Suit Against FDA
Associated Press

A federal court agreed yesterday to rehear a case that aims to get terminally ill patients early access to experimental drugs unlikely to be approved before they die.

The full 10-judge U.S. Court of Appeals for the District of Columbia Circuit will probably hear the case next summer, said Richard A. Samp, chief counsel for the Washington Legal Foundation.

The group, with the Abigail Alliance for Better Access to Developmental Drugs, sued the Food and Drug Administration in 2003. It is seeking broader access to drugs that have undergone preliminary safety testing in as few as 20 people and have yet to be approved by the FDA.

In 2004, a district court dismissed the case. In May, a three-judge appeals panel reinstated the lawsuit in a 2 to 1 decision.

The FDA, in turn, appealed and asked for the full court to rehear the case.
Yesterday the New York Times published a few letters pertaining to the issue of Medicare reform and specifically the issue of non-interference.

My letter, alas, was not chosen. (My mother-in-law was very upset.)

Here is what I wrote:

To the Editor:

Your editorial (Lowering Medicare Drug Prices, November 14, 2006) suggests that the Veteran’s Administration “negotiates” prices for prescription drugs. Not so, it mandates them – and that’s more than a rhetorical finesse.

Under rules set by Congress, to sell drugs to the VA, companies must offer each drug at a price that “represents the same discount off a drug’s list price that the manufacturer offers its most-favored nonfederal customer under comparable terms and conditions.” The medication must be offered “at a discount of at least 24 percent off [the] nonfederal average manufacturer price (NFAMP). An excess inflation rebate is also required, equal to the percentage by which the price increase for [the] drug has exceeded the consumer price index (CPI) in the prior period.” The manufacturer must make all of its drugs available through the Federal Service Schedule for any of its drugs to be eligible for reimbursement under the VA and Defense Department health systems, the Public Health Service (including the Indian Health Service), the Coast Guard, and the various state Medicaid programs.

A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA formulary’s drugs are more than eight years old and more than 40 percent are 16 years old or more. Just 19 percent of all prescription drugs approved by the FDA since 2000 are available to veterans; only 38 percent approved during the 1990s are.

There’s a big difference between negotiating and mandating – and it’s not a thin line. My fear is that a government negotiated Part D plan is but the first step towards a more strident program of government price controls.

Sincerely,

Peter J. Pitts
Center for Medicine in the Public Interest
Health Affairs is running a study showing that most seniors have a coverage gap...what is left out or unstated or misconstrued is that fact that most seniors have chosen to have a coverage gap....Here is what the study notes but fails to highlight...

“United’s AARP product leverages beneficiaries’ recognition of the AARP ‘brand’,” while “Humana attracted high enrollment in its Standard PDP with an aggressive low-premium strategy.”

In otherwords, people are choosing coverage based on values that matter to them, not what matters to elites. That was the point of competition. Also unstated is the fact that copays in the plans with most customers have declined as have the price of drugs outside the coverage period. That is also in response to demand.

How soon people forget that consumers, not policy elites, are in the drivers' seat here. Will people like it if the elites rob them of their choce o f plans, deductibles and drugs to satisfy elite concerns about "coverage"?

I don't think so...
This is my next to last post from Israel....

Since everyone who supports the government getting into the business of compraing the effectiveness of drugs have assured me that the methodological issues are quite easy to address I am announcing a pre-Thanksgiving comparative effectiveness contest to come up a way of establishing the comparative effectiveness of using different cancer drugs with the technological advance described in this article:

Toward Reducing The Toxic Side Effects Of Cancer Chemotherapy
An advance that may speed the use of "prodrug chemotherapy" -- one of the most promising new strategies for reducing the side effects of anti-cancer drugs -- is being reported by scientists from Johns Hopkins University's In Vivo Cellular and


This two-part chemotherapy involves giving patients the inactive form of an anti-cancer drug (the "prodrug") and an enzyme that changes the prodrug into an active, cancer fighting form. Patients first get the enzyme, which is gradually eliminated from normal tissue but builds up and remains in the tumor. Then patients get the prodrug, which changes into its active and toxic form only upon encountering the enzyme in the tumor.

"Determining the optimal time-window for prodrug injection is therefore of utmost importance for success of these strategies," Zaver M. Bhujwalla, lead author Cong Li and their colleagues note in a report scheduled for the Nov. 29 issue of the weekly Journal of the American Chemical Society.

If the prodrug were injected before all the enzyme cleared from normal tissue, it could damage normal tissue and cause body-wide side effects, they say.
The report describes the synthesis and early laboratory testing of the first prodrug-activating enzyme that can be imaged in tissue to time administration of the prodrug. The enzyme produces the active form of the common anti-cancer drug 5-fluorouracil. Its elimination from normal tissue can be monitored with magnetic resonance imaging (MRI) or optical imaging, according to the researchers."


Anyone want to come up with a method of comparing the effectiveness of delivering 5-F with side effects and without that a) does not delay access to new technologie, b) captures individual response to pro-drug injection since that will be key to optimal treatment and c) determine whether alternative drugs delivered in pro-drug or non-pro-drug fashion are the best for a particular cancer at a particular state? And extra credit for figuring out a way to continually add new drugs and new approaches in real time as opposed to when it is convenient for bureaucrats and politiciians

The comparative effectiveness crowd wants to spend a billion a year on this approach as a cure all for drug costs and a filter for setting up drug formularies AND it will be proposed as a way to set government prices for breakthrough drugs.. A Dunkin Donuts coupon for the winner of contest....We promise to post the results and responses...


Bonus question

Come up with a comparative effectiveness method for evaluatng the folowing advance:

Nanoparticle-Arsenic Combination Makes for More Potent Anticancer Agent
Arsenic trioxide, one of most promising drugs for treating acute
promyelocytic leukemia, encapsulated in lipid-based nanoparticles
designed to release their cargo inside tumor cells.

Peeling The Onion

  • 11.20.2006
This is not a real news story -- it's from today's edition of The Onion.

But it could be real if we don't address the building momentum towards evidence-based medicine and its cost-centric vs. patient-centric worldview.

End-Life Crisis Marked By Extravagant Spending Spree
The Onion, November 20, 2006

TOLEDO, OH—Ever since his retirement nearly a decade ago, area resident Oscar Subitzky just hasn't been the same. What began as a single, uncharacteristic extravagance—the payment of $15,000 for a coronary angioplasty to expand his narrowing arterial wall—has given way to a growing number of personal luxuries, from the latest brand-name heart medications to the most advanced palliative care. The unusual developments have led concerned family members to suspect that the once prudent and conservative 74-year-old widower is undergoing an acute end-life crisis.

"Sure, the operation seemed a little indulgent at first, but we could tell it was really important to Dad, so we didn't try to stop him from having it," said daughter Martha Welsch, 46, who can still remember when her father didn't need "pricey doodads" like defibrillators and cardiopulmonary-resuscitation devices to be content. "We all thought this was going to be a one-time thing, that it was just something Dad had to get out of his system, and then things would go back to normal," she said.

"Unfortunately, one surgery quickly became two surgeries, which soon turned into three surgeries," Welsch added. "That's when we realized the whole thing was a lot more serious than Dad just wanting to get a clogged artery cleared."

Subitzky's end-life crisis began when he suddenly left a secure job as an accountant at the age of 65. Welsch admitted she didn't quite understand what had come over Subitzky until he announced six months after his retirement that he had started seeing a cardiologist nearly half his age.

"You hear those stories about men in their late 60s all of a sudden coming home with an expensive new pacemaker or deciding to get work done on their kidneys out of the blue, but Dad just never seemed like the type," Welsch said. "If he honestly thinks that spending thousands of dollars on blood transfusions is going to change the way he feels inside, I'm afraid he's got another think coming."

Lately, Welsch said, between "all those fancy new breathing tubes he now wears," and the company of a new live-in nurse only a few years older than some of his grandchildren, she sometimes doesn't recognize her father.

"What's he going to do next, gallivant off to some $10,000-a-day, all-inclusive hospice?" she wondered.

In addition to throwing money around "like there's no tomorrow," as Welsch puts it, Subitzky has also reportedly grown obsessed with his appearance, examining his body for lumps, bruises, or signs of congested veins dozens of times a day. According to son Patrick Subitzky, 39, who admits to being a little embarrassed by his father's newfound vanity, the older man's obsession with his looks has also resulted in a "ridiculous new diet" of only dark-green leafy vegetables, fruits high in citric acid, whole-grain cereals, and absolutely no meat or dairy products.

"I love him and everything, but I don't know who my father thinks he is anymore," said Subitzky, who cringes every time his elderly father speeds around town in that "loud and flashy" ambulance. "He's even talking about a trip to Denver to see some heart specialist there. Whatever happened to the Oscar Subitzky who hated to travel?"

According to psychologist Elizabeth Schulz, who specializes in mortality-identity issues, an end-life crisis is an emotional state of fear and anxiety that often affects men and women between the ages of 65 and 100, and is usually sparked by the uncomfortable realization that one's time on earth is limited.

"Individuals in the middle of an end-life crisis are usually easy to spot, as they tend to foolishly acquire big-ticket items such as liver transplants to compensate for feelings of growing inadequacy," said Schulz, who in the past several years has observed increasing numbers of clients suffering from the common disorder wheeling themselves into her office. "While these shortsighted material purchases will often work at first, leaving the individual feeling rejuvenated and even energized, in the long term they have very little effect."

In the meantime, Welsch is hopeful that her father will eventually move beyond his present situation into a better place.

"I'm praying this is just a phase that will pass," Welsch said. "Hopefully in a couple of months this will all be over."
What a difference a day (or two) makes.

On 11/15 Senator Grassley wrote to Senator Enzi and Senator Kennedy that the FDA “needs and deserves a strong permanent Commissioner.”

On 11/17 he placed a “hold” on the nomination of Dr. von Eschenbach.

Maybe he’ll change his mind again tomorrow.

Maybe. Maybe not.

Maybe he needs to stop playing politics with the public health.

Maybe
isn't good for the public health or the future of the FDA.
Some new and crucial statistics from the WHO:

* Medicines purchased over the Internet from sites that conceal their actual physical address are counterfeit in over 50% of cases.

This should be cause for pause and reflection for those in the US who are calling for various and sundry importation schemes.

* Counterfeiters exploit weaknesses in border control whenever governments try to promote world commerce by reducing border inspections.

And yet we've passed a law that prohibits US customs and border control agents from opening packages of foreign prescription drugs coming into the US.

* In 2004 over 60 tons of stolen, expired, and counterfeit pharmaceuticals were seized by federal agents in Mexico.

And it's been shown time and time again that many of the drugs being sent from the Great White North into the US begin their journey in sunny Mexico.

The complete WHO report can be found at:

Counterfeit Medicines: an update on estimates

We here at Drugwonks respectfully suggest that, when it comes to trying to legalize drugs "from Canada" ("In Canada," as always, in quotes), Speaker-Presumptive Pelosi stop asking "how" and start asking "WHO."
Further thoughts on "banning" pharmaceutical sales representatives from Stanford University Medical Center ...

Click on the link below. The article is on page 8:

http://rxcompliancereport.com/issues/2006/RxComp1116.pdf
To read the testimony of all of but one (and a half) of the witnesses who presented before the Senate HELP committee, you can't help wonder whether the object was to pay homage to the dreadful IOM report or ignore the connection between science and FDA reform. Witnesses -- with the exception of Greg Simon's Faster Cures and the head of Benefit and Risk analysis at J and J were literally tripping over themselves talking about how important it was to spend all this money on making sure each and every drug was equally safe. Only Greg and the J and J guy managed to point out that embedding bean counters and epidemiologists from the Office of Drug Safety and giving them authority over drug appovals and study designs might add to the cost and time of new drug approvals without regard to the relative benefits of medicines. And the entire discussion was disconnected from ongoing efforts by the FDA to make pre-approval a more targered path that actually focused on eliminating safety problems.

Only Greg pointed out that the real value of a cliniical ttrials registry was to help avoid potential safety flaws and develop more targeted medicines and treatment regimens on a real time basis. (I think the industry is inching towards acceptance ... as it should)

And only Greg made the point, diplomatically, that the real crisis is not a lack of safe drugs but a lack of effective CURES being developed for patients being killed and crippled by horrible illnesses. As Garret Fitzgerald cogently observed and was cogently quoted (kudos to those reporters who did their job in this regard) with respect to studies about Arcoxia, Merck's latest COX-2, the use of many drugs for broadly shared problems (pain) will have to be tailored by metabolic response, age, co-morbidity, instead of banned and panned outright.

There is an unhealthy relationship between the HELP committee and the IOM panel ... There is no speaking truth to power. Instead, it is an effort on the part of the IOM committee to pass legislation it likes. I hope the committee ignores IOM and listens to Greg Simon.

Better use of medicines in a targeted fashion require a total feedback loop and not a balance of cultures or a massive purcahse of claims databases or the FDA's equivalents of a quasi-kosher certification as the IOM proposes. It would have been nice if the IOM had some really scientists on the panel...but that would have meant having a chair who wasn't threatend byy such expertise....
Merck, Lilly and Celgene have all invested heavily in technologies or companies that enable or are directly engaged in stem cell research. None of the projects are turning a profit or will likely do so for years. If Pelosi's Part D plan is implemented....slashing prices and profits of today's drugs by 40 percent with more of the same for stem cell cures in the future along with
new hurdles including comparative effectiveneess studies that take years to compelte and mandatory delays of at least a year (that's the VA anyway) in even allowing something to be used off formulary...what will happen?

Oh, and let's not forget the safety requirements that add at least two years to the time it takes to get such cures to dying patients.

Great assurances of safety in the Post-Pelosi/Waxman world means more and longer clinical trials instead of personalized medicine.

Well, the D's said they didn't want the status quo.
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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