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David Cutler, Harvard University health care economist extraordinaire, was lead author of study look at the value of medical care. After estimating that half of gains in life expectancy are attributable to medical care (the rest due to lifestyle changes and fewer murders, accidents) Cutler and company found:

:…although medical spending has increased substantially during the past 40 years, the money spent has provided good value. However, temporal trends suggest that the value of health care spending is decreasing over time, particularly for older age groups. “

Cutler adds two important qualifications: “Studies suggest that there were substantial improvements in the quality of life during this period, especially among the elderly. Thus, our estimates are likely to have understated the value of medical spending. Finally, although we excluded gains in life expectancy that were due to nonmedical interventions, we did not exclude their associated costs, owing to the difficulty of disaggregating them from the overall costs of health care. This resulted in the overstatement of cost increases and thus the understatement of the value of medical advances. ” In otherwords, medical spending is probably more valuable than reflected in the study..

Of course the Leftists countered that other countries had similar increases in life expectancy with less money. But you can make international comparisons…too much variation within the US, let alone between countries. The true comparision, comarping gains due to medical intervention only demonstrate the superiority of our system…cancer, stroke and heart by pass mortality rates…no contest…Sorry Gooz…Get your facts straight for once..

And leave it to Sid Wolfe to come up with the meanest and most pointless comment:âThe fact that someone is writing this paper shows how desperate the health care system is to justify these out-of-control increases in health spending,â So in otherwords, every time Sid Vicious writes a paper it is an act of desperation? Here’s the difference: David Cutler is a well respected economist who has published in peer reviewed economic journals and has advised presidential candidates on health care reform ranging including Bill Bradley. And Sid Wolfe is just a hack.

The article on PDUFA in today’s WSJ is headlined “Drug Firms Use Financial Clout To Push Industry Agenda at FDA” conjures up an image of drug companies conspiring to ram useless and dangerous drugs through the FDA. I mean, what else do you with financial clout except water down regulations governing safety and efficacy?

Turns out (and Anna either doesn’t know or doesn’t think it’s important) both biotech and pharma companies would like to devote some user fee money to fund Critical Path programs that would allow the FDA to hire and train scientists who can use new molecular tools and new clinical trial methods leading to more targeted and personalized medicines. Then there is an effort to help the FDA establish collaborations with large health systems to collect clinical data in cooperation with companies after a drug is marketed. Finally, there is talk of devoting some money to promote industry, academic, and agency initiatives like the one created with MIT Center for Biomedical Innovation to develop software for detecting adverse drug effects and reactions of new drugs after they hit the U.S. market or the one with the Critical Path Institute to develop a biomarker to do the same thing before a drug goes into development.

Only a professional scowl like Sid Wolfe (see post above) would complain this is a waste of additional industry funding. Why is it that Mathews couldn’t report on these possibilities?

Remember the nearly gleeful article Stephanie Saul wrote about Apotex had outfoxed Bristol and Sanofi just a couple of weeks ago? And the fawning piece that described Apotex CEO Bernard Sherman as both a wily businessman, consumer crusader and man of charity? Well, now that Apotex has had the law shoved down its throat, Stephanie seems a bit dazed and uncharacteristically plays it straight for once … almost like the news jarred her back to the default settings of objective reporting…

September 1, 2006
Generic of Plavix Is Blocked

By STEPHANIE SAUL

A federal judge in Manhattan ordered a Canadian company yesterday to stop distributing its generic version of the blockbuster anticlotting drug Plavix, granting a reprieve to Bristol-Myers Squibb and Sanofi-Aventis, which co-market the brand-name drug.

The Plavix marketers had seen a drastic erosion of their United States sales since the Canadian company, Apotex, introduced its generic version on Aug. 8 in a challenge to the patent held by the big companies. Analysts say that the large supplies of the generic drug already on the market could continue to impinge on sales of Plavix for several months …

Judge Stein did say that the patent was likely to be enforceable, based on the evidence and testimony so far. He also observed that Bristol-Myers and Sanofi had suffered “irreparable harm” as a result of the patent infringement.

He nonetheless required Bristol-Myers and Sanofi to post a $400 million bond to compensate Apotex in the event the generic company won in a trial on the validity of the patent, now set to begin in his court next January …”

Apparently the judge did not buy, as did Stephanie, Bernie’s claim that he never intended his wheeling and dealing (getting BMS and Sanofi to pay for only half of generic sales if it lost its patent suit) to really mean anything, citing as evidence letters he sent to Chuck Grassley in which he wrote that he hated all the wheeling and dealing. The judge saw it for what it was: a shakedown that was part of an effort to void the patent without exploring the validity of the patent itself …

“In his 57-page ruling, Judge Stein wrote, ‘The public interest in lower-priced drugs is balanced by a significant public interest in encouraging the massive investment in research and development that is required before a new drug can be developed and brought to market.’”

Those of you who want to see Judge Stein’s entire ruling can go to this link:

http://www.nysd.uscourts.gov/courtweb/public.htm

100,000!

  • 09.01.2006

In August, drugwonks.com received over 100,000 visits. (And considering we’re not a “mass” blog, we think that’s pretty terrific.)

Thanks to all of you for helping make drugwonks.com such a success.

(Yes, you too Senator Grassley.)


This just in from the WSJ.

And it’s astounding.

Scientists Use Gene Therapy
To Shrink Malignant Tumors

For the first time in the history of treating cancer, gene therapy has apparently succeeded in shrinking and even eradicating large, metastatic tumors.

The therapy worked in only two of 17 patients who were treated. But many researchers are hailing the study, which was published Thursday in the online edition of Science, as groundbreaking because it provides compelling evidence in human patients that gene therapy can be effective against one of the toughest challenges in medicine: terminal cancer.

Moreover, the technique used in this pilot study — genetically altering immune-system cells so that they target tumors — could eventually apply to many different kinds of cancers, not just the cancer that afflicted patients in this trial, which was melanoma.

Here’s a link to the entire article:

http://www.wsj.com/article/SB115704231287350662.html?mod=home_whats_news_us

We’re waiting to see what Senator Grassley has to say.

Put up or shut up

  • 08.31.2006

Per the FDA’s list of Canadian Internet pharmacies that are selling counterfeit drugs, Andrew Strempler, founder of Mediplan (considered the first Internet pharmacy), says the FDA allegations are false.

Strempler : “We test our products and stand behind our products.”

drugwonks.com: “Put up or shut up.”

Governor Schwarzenegger is supporting pharmaceutical price control legislation that the people of California have already rejected once — and recently. Unless cooler heads prevail it could very well be hasta la vista medical progress.

Here’s what I had to say about it in the Orange County Register:

http://www.ocregister.com/ocregister/opinion/abox/article_1258737.php

As California goes so goes the nation? We should all hope not.

"Canada" in Quotes

  • 08.30.2006

Counterfeit drugs are a serious danger.

Senator Vitter, et al., who think “from Canada” always means “from Canada” need to pay attention to the facts, reconsider their position — and put the public health in front of political posturing.

A good place to start would be to read the lastest FDA news release. Here it is.

FDA Warns Consumers Not to Buy or Use Prescription Drugs
from Various Canadian Websites that Apparently Sell Counterfeit Products

The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter.

FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market.

Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed.

DRUG NAME
USE(S)

LIPITOR
Cholesterol disorders

CRESTOR
Cholesterol disorders

ZETIA (US name) / EZETROL (Canadian name)
Cholesterol disorders

DIOVAN
High blood pressure

HYZAAR
High blood pressure

ACTONEL
Osteoporosis in postmenopausal women

NEXIUM
Gastroesophageal reflux disease (GERD)

CELEBREX
Arthritis-related pain

ARIMIDEX
Breast cancer

PROPECIA
Male-pattern baldness

Some of the websites that are operated by Mediplan or that have order fulfillment through Mediplan are:

www.RxNorth.com;
www.Canadiandrugstore.com;
www.Rxbyfax.com;
www.Northcountryrx.com;
www.Canada-pharmacy.com;
www.My-canada-pharmacy.com;
www.NLRX.com;
www.Canampharmacy.com;
www.Canada-Meds-For-Less.net; and
www.Canadian-safe.com

As a general matter, FDA advises consumers to use caution when buying medical products online. Although a website may appear reputable and similar to legitimate retail pharmacy websites, many actually operate from outside the U.S. and provide unapproved drugs from unreliable sources.

For example, in August of 2005, FDA conducted an operation at New York, Miami, and Los Angeles airports which found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with “Canadian pharmacies.” Of the drugs being promoted as “Canadian,” based on accompanying documentation, 85 percent actually came from 27 other countries around the globe. A number of these products also were found to be counterfeit. These results demonstrated that some Internet sites that claimed to be “Canadian” were, in fact, selling drugs of dubious origin, safety and efficacy.

Today’s announcement is consistent with FDA’s earlier message of the dangers posed by such websites and the need for caution on behalf of the public.

Drug counterfeiting is illegal for good reason. Drug counterfeiting defrauds consumers and can expose them to products containing unknown, ineffective, or harmful ingredients. Counterfeit drugs may be toxic or contain doses that are too small to treat a medical condition, or so large that they could endanger the health of the user. Because of the dangers posed by counterfeit drugs, the FDA aggressively investigates all instances of drug counterfeiting.


Headlines claim that CMS spent $275 million on a quality demonstration project to measure cancer care that proved nothing…

Here’s the lede of the story as reported by AP

Report questions millions spent on effort to measure patient care
Wednesday, August 30, 2006
Kevin Freking
Associated Press
Cancer doctors received about $275 million from the federal government and the elderly last year as part of a yearlong research project that many doctors believe won’t produce any useful findings.

Under the program, the federal government paid $130 each time a chemotherapy provider assessed a Medicare patient’s pain, fatigue and nausea. The payments were designed to encourage doctors to report information that might one day lead to improved care for cancer patients….

Iowa Republican Sen. Charles Grassley, chairman of the Senate Finance Committee, said taxpayers and beneficiaries were “bilked” because they paid for services that physicians are already supposed to provide. …”

Let the record show that ” Senator Chuck Grassley (R-Iowa) and Senator Max Baucus (D-Montana) have presented a bill that entitles providers that report quality data and satisfy particular quality standards to obtain full Medicare reimbursement along with bonuses. Providers who do not report data will only receive Medicare reimbursements at the full rate of inflation minus two percentage points…”

If someone can explain the difference between what Medicare is doing and what Grassley has proposed, please comment….

Meanwhile, as to the OIG claim that the data is useless, let the record show that CMS will reimburse physicians who report whether their treatment of patients adheres to recommendations in nationally recognized practice guidelines published by either the National Comprehensive Cancer Network (NCCN) or the American Society of Clinical Oncology. The demonstration will focus on thirteen cancer types that account for at least 80% of all patients with cancer in the United States. ” Now this might not be outcomes data but at least it is a start…a baseline for measuring the transition to products that don’t produce such side effects and don’t require hospitalizaton…get it? Such measures are important since you would be astounded how many people don’t complete cancer care because of pain, fatigue and nausea and therefore die as a result. So compliance with protocols to reduce such feelings matter a hell of a lot. And the payment for collecting such data is less this year, a little fact that both OIG and news accounts forgot to include.

Shame on Grassley for grandstanding and being so grossly hypocritical in the process.

As we were saying … Case in point, today’s article in The Washington Post by left wing and fringe group shill Shankar Vedantam (he who quotes nutcases from the Alliance for Human Research Protection without revealing their biases)

Group Says FDA, Advisory Panels Show Bias Toward Drug Approvals

By Shankar Vedantam

“The panels of experts assembled by the Food and Drug Administration to advise it on whether to approve new drugs and medical devices are often biased in favor of recommending approval, according to a consumer group’s analysis released yesterday …”

Shankar goes on to note that the report was put out by “the National Research Center for Women & Families, a policy research and advocacy group.”

Well they are, sort of, if you also think that Moveon.org is a policy research and advocacy group. The Center, which claims to receive funding from NCI, also received money from the Tides Foundation, an organization that gives money to some of the most radical left wing organizations in the world including The Ruckus Society, a radical antiglobalization group. One of the Tides Foundation’s principal recipients is the National Lawyers Guild (NLG) ‘March 20 [2004] call to End Colonial Occupation from Iraq to Palestine Everywhere” organized by International ANSWER (a Stalinist front group). Immediately after 9/11, Tides formed a “9/11 Fund” to advocate a “peaceful national response” to the opening salvos of war. The Foundation replaced the 9/11 Fund with the “Democratic Justice Fund,” which was established with the aid of George Soros’ Open Society Institute.

(Soros, a currency speculator and drug legalization advocate, is a major contributor to Tides, having donated more than $7 million.)

Tides has also given grant money to the Council for American-Islamic Relations (CAIR), which recently sponsored a National Press Club briefing for the Stephan Walt and John Mearsheimer, the two ‘academics’ who blame the “Israel lobby” (Jews) for terrorism.

Does this mean that the National Center is just as bad as the rest of the Tides bunch/ No. But it gives you an idea of how they lean which in turn shapes the conclusion of any report they wrote about the FDA — so well timed for the confirmation vote of Dr. von Eschenbach. And since Tides is just a pass through, just who is really given them the dough?

Lazy and biased reporting by Shankar. And as for the Center, lLike we said, the opposite of anti-industry is objective.

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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