Let history be the judge

• 11.24.2009

Deats don't fail me now

• 11.23.2009

When Mike Deats talks, people listen – and they should.

Deats (the well-respected head of enforcement at the Medicines and Healthcare Products Regulatory Agency in the United Kingdom) says, “People can be reassured that it is extremely rare to receive counterfeit medicines from either a registered UK pharmacy or from any other legitimate outlet.”

And he’s right.  But that doesn’t mean that counterfeit medicines isn’t an important health issue – it is.  And the time to deal with it is now – before it becomes a more significant problem, as it already is much of the developing world. There's a lot of money to be made and the penalties for selling counterfeit medicines are small.  It's a serious problem that needs to be seriously addressed.

As the Financial Times reports, “While seizures of counterfeit drugs by European customs agents have risen significantly in recent years, the proportion of fake prescription medicines sold through pharmacies and other regulated networks remains modest.” But there’s a lot of money to be made by criminals selling counterfeits over the Internet – and there have been more than a few cases of fakes entering the legitimate pharmaceutical supply chain in the United Kingdom.

And, it's important to note, that many Canadian Internet pharmaceies source their goods from British pharmaceies -- 20% of whose product comes from other "lower cost" parts of Europe.

On a similar note, Mickey Arieli, director of the Israeli Health Ministry's Pharmaceutical Crime Unit, says that “Israelis and former Israelis are behind many of the world's Internet sites that sell counterfeit or other illegal drugs involved in pharmaceutical crimes, providing useless or dangerous products to people who think they are getting the real thing.”

According to Arieli, prescription drugs meant to treat serious diseases like cancer, malaria or attention-deficit hyperactivity disorder were reaching the public, especially via illegal Internet sales.

Most counterfeit drugs, said Arieli, are manufactured in China, but Arieli points to illegal Web sites operated by Israelis or former Israeli residents that expedite the transfer and payment for them.

The time to address counterfeit medicines is now -- before it becomes a public health crisis as it already is in much of the developing world. The profits are high and the criminal penalties are low. And, unless we address the issue -- the problem is only going to get worse.

The Junk Science of Obamacare

• 11.20.2009

Maggie Fox nails it. The administration uses selective evidence to save dough on health care and caves in to superstition in shaping vaccine policy.

Read the full article here.


By Maggie Fox, Health and Science Editor Maggie Fox, Health And Science Editor – Fri Nov 20, 12:36 pm ET

MedWatchword

• 11.20.2009

Relative to a social media and the angst-ridden issue of adverse event reporting, here's an idea -- what about an FDA an FDA Facebook page that people can "friend" and through which the FDA can push out information about early safety communications, important safety alerts -- and how to report "official" 4-part adverse events

For more on making MedWatch a better and more user-friendly tool, watch this space.

What Is Shannon Brownlee Doing At NIH?

• 11.20.2009

Nothing good. (She is a visiting scholar at the National Institutes of Health, Clinical Center, Department of Bioethics) 

First, she is peddling the questionable claim that up to 30 percent of medical care in the US is unnecessary based on a misreading of the Dartmouth Atlas which is already coming under fierce critcism.   

Second, she is questioning the efficacy of all flu vaccines. 

And now it seems she is using her perch as a visiting scholar to coordinate the writing of a letter to NIH Director Collins by 100 so-called scientists and experts demanding that the NIH study the impact of conflicts of interests on medical research, etc. 

And it appears that most of the signatories to the letter are drawn from a list of people that Brownlee and her anti-science collaborator and serial retractor Jeanne Lenzer put together a year ago that they deemed free of pharma influence.  Pharma influence perhaps, but not free of trial attorney association or affiliation with Socialist organizations that regard profit of any sort in healthcare immoral. Those too are conflicts or biases -- along with a willingness to abuse one's government position to aid and abet a narrow political agenda -- but those are not to be the subject of any NIH study suggested by the letter writers.  Perfectly fine to be free of pharma support... the question is, are they free of conflicts now that they are are petitioning the NIH where the woman who helped organize and coronate them as unconflicted now resides as a visiting ethicist?   I guess anything is permissible as long as no money from drug companies is involved.  So goes the new morality...

You can compare the signatories to the holier than thou missive and Shannon's circle of purity  here..

http://groups.google.com/group/misc.activism.progressive/browse_thread/thread/52ddee237f64e8e4?pli=1

www.pharmedout.org/NIHletter.pdf

Someone ought to investigate Brownlee's role in soliciting the letter, whether she used her time or position at NIH to coordinate the effort.  Also, it would be interesting to note if merely writing opinion pieces is what her job entails and whether it is an appropriate use of tax dollars to subsidize an activity that could otherwise be performed in the private sector. 

Asocial Media

• 11.19.2009

(AP)

NEW YORK — The Food and Drug Administration said Thursday it issued 22 warning letters to Web site operators over alleged illegal sales of unapproved or misbranded drugs.

The agency said the move caps a weeklong international effort aimed at curbing illegal actions regarding medical products, including sales. In all, the FDA and its partners in the program targeted 136 Web sites that appeared to be illegally selling medical products.

None of the Web sites were for pharmacies in the U.S. or Canada, the agency said.

The Selective Use of Science in Health Policy

• 11.18.2009

As I note in my article in the American Spectator today, (spectator.org/archives/2009/11/18/breast-cancer-follies) the US Preventive Services Task Force www.ahrq.gov/CLINIC/uspstfix.htm   (bet you didn't know it was effectively a mouthpiece for AHRQ comparative effectiveness research and  -- based on AHRQ research --  the final word on what and will be covered under all health care reform bills) has pulled the plug not only on the most reliable tool for breast cancer screening thus far, but also what is becoming an important test for determining whether women are at risk for heart disease. 

The rationale given in both cases:  What we know about the limits and net benefit of screening for everybody is precise - based on a review of studies that we decided are good enough to review -- and that we don't know enough about new tests and tools to use them. 

www.forbes.com/2009/11/16/mammograms-cancer-screening-business-healthcare-mammogram.html

The result?  Less screening now and delayed use of newer tools based on scientific advances for years to come. 

Follow the logic of the Task Force members:

"Dr. Kerlikowske counters that the new USPTF guidelines are based on a far more detailed and rigorous analysis of the mammography data than has ever been done before. (The USPSTF reviews its guidelines every five years.) "There is new evidence to precisely quantify benefits by age. It didn't exist before," says USPSTF's Diana Petitti. "Those lines of evidence came together to a conclusion that the net benefit of starting earlier rather than later was small."

Precisely quantify benefit?  Are we to presume that the benefit is exactly the same for all women without family history of breast cancer?  What about those who have not been screened for genetic inclination?  And what is net benefit?  Sort sounds like a collective benefit to me.  Meanwhile, what started all this is the untested assumption that too much screening leads to too much treatment.  Is that true?  Where is the precision for that number?

The decision to ditch the use of CRP to predict heart disease risk in women of the same ilk.   The concern is not public health, but what such tests do to generate "too much" treatment.  And again the evidentiary standard is one that ignores the very individual or subpopulation differences necessary to real precision in order to obtain a "net benefit" for a health system.    The willful disregard of the JUPITER data as it pertains to women is shocking.  Setting aside the real benefits of treating women with high CRP levels with statins in the trial,  the study demonstrates that testing for CRP is an important predictor of and precondition to reducing death from heart disease. 

online.wsj.com/article/BT-CO-20091117-715499.html

At the very least, the Task Force decisions should factor in the impact on compliance.  Ironically, the administration had no problem yanking adjuvant out of H1N1 vaccines to appease Mercury moms and others for whom believing vaccines poison children is a new religion.  Or as an administration official said in a recent hearing explaining the mounting delays in vaccine availability, which in turn has lead to doubts, cynicism and apathy about immunization: 

If adjuvants were added to the vaccine supply, many of the unadjuvanted doses would need to be taken out of the supply she said.

Also, public confidence in vaccines, in particular vaccines with adjuvant is low, she said. "And we didn't really want to rock the public confidence in a new vaccine with adjuvant."

http://www.medpagetoday.com/Geriatrics/Vaccines/17081

Caving in to unfounded fears is justified to promote public confidence.  But what about caving in to cost control concerns and claiming you relied on the best evidence available?  Both approaches are driven by politics, not by medical science.

Who needs mammograms anyway?

• 11.18.2009

So why the fervent outcry from many Americans and health care organizations over the new federal guidelines pertaining to mammograms?

The Washington Post reports:

“The new recommendations took on added significance because under health-care reform legislation pending in Congress, the conclusions of the 16-member task force would set standards for what preventive services insurance plans would be required to cover at little or no cost.”

The American Cancer Society, which endorsed the recent health care bill that passed the House of Representatives, publicly condemned the new guidelines.

LIVESTRONG CEO Doug Ulman also joined in the criticism:

“Since the U.S. Preventive Services Task Force issued these reversals, LIVESTRONG and our partners at the American Cancer Society have heard from legions of women under 50 who are breast cancer survivors and many more whose lives were saved as a result of a routine self-exam. The work that has saved their lives must be sustained, not discarded.”

There is arguably a great deal of waste in our health care system. But to focus cost concerns on one of the most positive aspects of our system (cancer screening and cancer treatment) simply defies all common sense.

Indeed, First Lady Michelle Obama praised US superiority in this area of medicine just last month at a White House Breast Cancer Awareness event:

“And today, because of that work, the number of women getting regular mammograms has dramatically increased, and the five-year survival rate when breast cancer is diagnosed in time is 98 percent -- and that's compared to 74 percent in the early 80s.

“And today, we spend $900 million on breast cancer research, which is 30 times more than what we spent in 1982. So we have come a long way.”

And, just maybe, more government control of the health care sector is not the answer.

According to this June 2009 study by the Employment Policies Institute, both insured and uninsured American women fare substantially better than their Canadian counterparts (who we are told enjoy universal coverage) in the area of cancer screening:

“When it comes to cancer screening, 80 percent of insured women (in the USA) ages 40-64 had a mammogram within two years of the interview; and 87 percent when the period of receipt is extended to 5 years. That compares to 49 percent of uninsured women who had a mammogram within two years and 65 percent when the period is within 5 years. However, those screening rates are relatively high even for uninsured women when compared with screening rates in Canada, a country with universal health coverage. The Canadian health survey reports that 65 percent of Canadian women ages 40-69 had a mammogram within the past 5 years, the same percentage as uninsured women in the U.S. When it comes to Pap Smears, Canadian women also have about the same rate of screening over the past five years as uninsured women in the U.S. (80 percent), although those rates are below those of insured American women, among whom 92 percent were screened. Among U.S. men ages 40-64, 52 percent of those with insurance were screened for prostate cancer with a PSA test within the past 5 years, compared to 31 percent for men who are uninsured. (In Canada, the comparable percent is 16 percent.)”

Food for thought.

Health Insurers and CER

• 11.18.2009

Why Not Punish Rising Auto Prices Too

• 11.17.2009

The NY Times saw fit to print that Rx sticker prices are rising on the front page of it's shrinking and increasingly expensive paper (didn't the times just raise it's price?)

http://www.nytimes.com/2009/11/16/business/16drugprices.html

http://www.nytimes.com/2009/11/17/business/economy/17econ.html

But when it ran an article on auto sales rebounding (see above) it failed to mention this which was on the AP.....

As auto sales rebound, price increases are likely

Written by Associated Press | | news@toledofreepress.com

When Rebbie Lewis McGowen decided to replace her 2000 Dodge Stratus sedan with a new loaded-out Jeep Grand Cherokee, she was amazed that her favorite dealer agreed to a price that was about the same as she paid for a similar Jeep nine years earlier.

“That’s why I jumped on it the first day I saw it,” said McGowen, 61, who got the silver sport utility vehicle from River Oaks Chrysler Jeep in Houston for about $34,000, $7,000 less than the sticker price.

Like many U.S. buyers, she took advantage of a depressed auto industry, one that in recent years has had too many factories churning out too many cars and trucks for too few buyers, forcing big discounts. Although sticker prices have risen, actual sales prices aren’t a whole lot different than they were nine years ago.

So far this year, average sale prices actually have dropped by about $800 to $25,586, according to J.D. Power and Associates.

But industry analysts don’t expect that trend to continue much longer. General Motors Co. and Chrysler Group LLC came out of bankruptcy protection with far fewer factories, and Ford Motor Co. for the past few years has been closing plants to align its output with demand.

Analysts say that with the industry’s massive restructuring, the big discounts that American consumers have gotten used to could go away as auto sales recover from the worst slump in more than a quarter-century.

“I just think it happened to be this point in time that I was able to make such a deal,” McGowen said. “Next year, when the 2010s come out, it’s not going to be the same situation.”

Growth in rebates, low-interest loans and other incentives may be starting to slow, reports the Edmunds.com automotive Web site. Across the industry, the average incentive per vehicle dropped from $2,869 in June to $2,735 in July.

But that could be an anomaly driven by increased demand from the government’s Cash for Clunkers program, which likely will expire in September. July’s figure is still $90 higher than the same month last year, according to Edmunds.

In addition to the restructuring, all of the Detroit Three are trying to develop better cars, ones that are so stylish, efficient, safe and reliable that people will pay more for them, similar to what Toyota Motor Co. and Honda have already accomplished in the U.S. market.

At Ford, the only one of the Detroit Three to evade bankruptcy court, getting more money per car is part of a strategy to return to profitability, Chief Financial Officer Lewis Booth said recently.

“We’ve all got to learn to flex the revenue muscle,” said Booth, who adds that Ford’s actual sale prices are up this year, even in a down market. “It’s driven by our new products, and that’s why were getting improved transaction prices. We’re getting a mixture of reduced incentives and higher value from the customer. We’re selling more higher-service cars, more options, and all of those are good for profits and revenue.”

Now that people are demanding we reimport drugs to reduce prices, why don't they be consistent and demand importation of cheap cars from China and India...?