Latest Drugwonks' Blog

Hello Dolley!

  • 10.19.2006
Meat and milk from cloned animals! Calls for absurd, unscientific labeling!

Just another day at the FDA.

According to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS. Plans to regulate cloned animals and food derived from them, should be released by the end of this year.

Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder” clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.

You want fries with that?

In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.

By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.

"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.

Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.

Perhaps this cause will be taken up by a new consumer advocacy organization –

(Sorry about that.)

Thin as a ... Reid

  • 10.18.2006
Here's what Maurice Hinchey (D-Inflated Ego) said about Les Crawford's misdemeanor plea:

"Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical. The American public has the right to know what else Lester Crawford may have done in office that could have lasting, detrimental effects on the FDA. "

We could apply that same standard to lots of public officials. Like Harry Reid for instance. Or maybe Hinchey's own dealings with the casino interests allied with Indian tribes in his own Sullivan County. According to the AP the entire Indian casino process is just a pass through for non-Indian interests:

"The tribal preference law gives Indian-owned companies and Seneca joint ventures cost breaks over non-Indian firms on casino projects. But most of the joint venture companies are using Senecas only as brokers or consultants, according to a review by the newspaper of casino contracts, as well as interviews with Seneca leaders, contractors and disgruntled Senecas."

Nothing illegal here. But maybe there is something inappropriate or unethical. Applying Hinchey's sanctimonious standards we can ask....What did Hinchey know about these deals and when did he know it?

As the highly moral Maurice says:

"Leadership starts at the top. "

Or does it start by looking in the mirror?
Good article today in the NY Times by Ron Rabin about NIH recommendations regarding lowering LDL levels....Rabin comments on an article in the Annals of Internal Medicine which recommends trying to hit low levels but warns against a one size fits all approach to doing so.... One of the author is concerned about no one really knows what the "right"combination of drugs will be to achieve that optimal target.

The Times articles quotes another article (hey, someone actually did some research) from Dr. Vincenza Snow that concluded:"
Patients respond differently to statins, with some achieving more success in cholesterol reduction than others, Dr. Snow said. But, she said, “our goal is not necessarily to get to a certain level of cholesterol, but to decrease heart attacks and strokes, and you can reduce that risk with a certain dose of statin.”

Personalized medicine. And for that you need a variety of medications, genetic tests and diagnostics. Simply shoving everyone onto the cheapest or oldest therapy at the lowest dose possible is not likely to be the most effective way to reduce risk. Which is what medicine should be all about.

Lead Balloon

  • 10.18.2006
CMS Floats Trial Balloon for Part D Data Sharing Initiative

Drug Industry Daily
By: Stephen Langel

The Centers for Medicare & Medicaid Services (CMS) is using a proposed rule issued today to test the legal waters for its plan to collect and share prescription drug plan data to base Medicare reimbursements on product comparisons, sources say.

The proposed rule would require any entities offering prescription drug coverage under the Medicare Rx law to provide the CMS with data about the products they offer, including drugs, biologics and medical devices, as part of their contracts with the government. "Through the appropriate use of the new prescription drug claims data, we have an unprecedented resource to help us learn more about prescription drug usage by seniors and how we can help seniors get the most benefit from prescription drugs," former CMS Administrator Mark McClellan said.

The CMS would then use the data, which includes various measures of the products' cost, to improve the workings of the Medicare program, according to the rule. The agency would also share this data with the FDA to "provide protection against adverse drug events" and with HHS' Agency for Healthcare Research and Quality's (AHRQ) to do comparative drug studies.

This development comes weeks after the initiative seemed dead because of questions regarding CMS' statutory authority (DID, Oct. 2). The agency is using the proposed rule to make legal arguments supporting the policy. "We are engaging in this rulemaking in order to resolve the statutory ambiguity," the rule said.

The agency believes that it has "broad authority" under the Medicare Rx law to share such data. Section 1860D-12(b)(3)(D) of the law provides the HHS secretary with the authority to "collect a broad array of data in order to properly carry out his responsibilities," the rule said. But the section also limits use of the data to work necessary to carry out the act.

However, the agency believes the law gives it some leeway, saying that if the secretary believes it is necessary and appropriate to carry out responsibilities even outside the scope of the section, he has the authority to do so.

The proposed rule prompted a strong response by both supporters and opponents of comparative trials. Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, told DID the rule is the foundation for cost-based medical coverage that shortchanges the public and "sets an extremely dangerous precedent." The CMS is "trying to take authority away from the doctors and give it to the accountants."

While McClellan had proposed comparative trials as a way to ensure the best medicines were covered, without him leading the agency this decision will devolve into a purely cost-based decision, Pitts added. "Once he's out the door, there's no guarantee" that this program will be run correctly. McClellan left the CMS last week for the American Enterprise Institute-Brookings Joint Center for Regulatory Studies.

PhRMA is cautiously optimistic about the rule. Comparative data "can offer a valuable source of information," a spokesman said. But research based on that data has a number of limitations, he added.

However, public interest groups such as Consumers Union have long supported this strategy and lauded the rule. "The CMS initiative is very exciting, and holds out the promise for major advances in understanding what works and doesn't work in the world of pharmaceuticals, and where short-term adverse reactions and long-term dangers may be lurking," Bill Vaughan, the group's senior health analyst, told DID.

The key to the program's success is not the rule itself, but the FDA obtaining sufficient funding to use the data, he added. The agency needs money from the Prescription Drug User Fee Act to "mine the CMS data for the gold nuggets of knowledge that it can offer. With adequate support, the FDA can use the CMS database to make the adverse event reporting system and
other postmarket approval monitoring work the way that consumers hope and expect."

Lester Crawford

  • 10.18.2006
George Orwell said, “Saints should always be judged guilty until they are proved innocent.” Les Crawford is no saint. He is just an American who served his country and the public health well over many years.

Hang in there Lester.

The China Syndrome

  • 10.17.2006
How is the spread of counterfeit prescription drugs being addressed in China?

Interesting new article in "Insight" (the official publication of the American Chamber of Commerce in Shanghai) that, indeed, offers insight into the views of PRC officials -- and the actions they are taking (or say they are taking) to combat the issue of prescription drug counterfeiting (aka: international health care terrorism).

See for yourself:

COVER STORY: Counterfeit Cures
The announcement that Genentech is going to cap the cost of Avastin was met with derision and skepticism -- if you read the accounts in MSM. Critics assert that drugs like Avastin and Revlimid are not worth their price. But a complaint is not a statement supported by analysis. The Lenny Saltz school of public policy is to use the price of 25 year old cancer drugs as a benchmark and then loudly bleat that new drugs don't add anything in terms of survival.

A more thoughtful and scholarly approach is taken by Richard Gralla of the NY Lung Cancer Alliance. Dr. Gralla was quoted by Andrew Pollack of the NY Times as say that Avastin is not "cost effective to society." But that is not what Dr. Gralla said exactly. I called Dr. Gralla up because in light of his research with other drugs to treat lung cancer -- which focused on improving quality of life -- the statement seemed cold and too dispassionate. What Gralla told me -- and I am paraphrasing here -- is that most new cancer drugs that are based on new pathways and novel mechanisms while only improving survival by a couple of months in the sickest patients are by definition advances. Are they cost-effective? By virtue of the fact that they add -- on average -- little to life expectancy most new targeted therapies are NOT cost effective to society if you use the old measure of a quality adjusted life year being worth $50000 or less.

But University of Chicago economists Kevin Murphy and Robert Topel have found that: "eliminating deaths from cancer would be worth $47 trillion to Americans. In other words, Americans would be willing to pay this amount to achieve such an increase in the length and quality of their lives."

Hence, the potential benefits of increased spending on medical innovation are so huge, especially compared with the cost or illnes, that much higher expenditures on medicines, diagnostics, etc are justified, along with the prices that are required to sustain investment "even if they only yield small declines in death rates." See the article "The Cost of Living" in Chicago Business School magazine.

One other point: the Avastin cost cap reflects an acknowledgement that different groups of people, with different diseases at different stages, genetic and clinical characteristics will require variations in doses. Drugs are going to have be part of solution and not sold as a stand alone product. "More" will be replaced with "optimal" and the standard will be "value" not "cost-effective."
That's the headline of an article in today's USA Today. Yes, USA Today. Welcome to the mainstream debate over whether "evidence-based medicine" means cost-based reimbursement or patient-centric treatment.

Have a look:
The word is that drug companies are now seeking to determine whether diabetes drugs can be used to prevent diabetes in those people who are on the cusp of the condition. I am waiting for the Seattle Times or another media outlet to run a story claiming that this effort to treat diabetes before it progresses is disease mongering designed to "get rich" just as it slimed effort to treat "pre-hypertension" as disease mongering a while ago. But of course, rolling out high priced products to treat people who are very sick is gouging those who have no choice. And since the data comes from drug companies or researchers who receive drug company money, the results can't be trusted in any event.

So we should simply ignore the evidence and medicine until truly pure research conducted on people at death's door is generated and results in medicines that are given away for free or at a generic price are made available.

But maybe I am being too idealistic....
Another example of how and why drug safety is divorced from personal shows seeking to depict those who abuse them as victims. This is post from an Ambien addiction website:

Hi Everyone,

I've been reading everyone's posts and I can truly say that Ambien seems to be affecting more and more people in this regard than many might think. I'm an associate producer for the Montel Williams Show and we're currently doing research on Ambien addiction and sleep disorders in conjunction with a sleep clinic here in NY. If you're interested in trying to beat this addiction or if you would like to share your story regarding sleep disorders, you're not alone and maybe we can help.

Feel free to contact me any time for more information

Now in fairness Montel Williams usually plays this kind of thing straight but to suggest that "Ambien affects more and more people..." is the sort of claim that one hopes is placed in context.

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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