Last week Andy von Eschenbach commented that "We all talk about change -- but usually change in somebody else." Keeping that in mind, have a look at today's lead editorial from the Washington Times ...

The recent food scares

Watching the never-ending hearings Democrats are now holding on the Food and Drug Administration reminds us of Al Capone's assertion that "I have built my organization on fear." Indeed, a day has not gone by that a show trial has not been held claiming that our drugs are unsafe, and, now that our food is poisoned because the agency is compromised by a cozy relationship between the industries, it is supposed to police and the regulators themselves. The four most common bacteria, including salmonella and e-coli, contribute to about 5,000 deaths each year and cost our economy nearly $7 billion annually. The recent spate of food-related problems -- ranging from spinach contamination to a peanut butter recall and now to the discovery that a poisonous additive may be in animal food imported from China -- underscores the importance of ensuring the safety of the nation's food supply.

But adding more bureaucrats, or, alternatively, threatening FDA officials with salary cuts, are not the responses our nation needs. The recent problems have a common theme: They are the product of a more global and industrialized process of food production that allows pathogens to spread and emerge more rapidly than was the case 20 years ago. Better tools for identifying and detecting outbreaks and contaminants in the food supply in real-time fashion are available but not in widespread use at this time.

The United States has a surveillance system in place for detecting emerging pathogens called Foodnet. In turn, it is supported by a series of labs called PulseNet that subtypes and electronically compares pathogens as they are discovered and detected. This network needs to be upgraded and enhanced.

Moreover, both the FDA and the Department of Agriculture should clear the path for the use of nanotechnology devices that will be able to detect toxins, pathogens and chemicals in the production and packaging of foods on the spot. Such devices could monitor the presence of such materials without on-site inspection. Also, they could be used to alert consumers to tainted products at the retail level.

Unfortunately, Congress is more interested in building up the size of government through fear-mongering rather than insuring the public safety with advances in technology. Capone would be proud.

Where's Elliot Ness when we need him?

From the Moscow Times ...

The State Duma will examine plans to stiffen penalties for manufacturers and distributors of counterfeit pharmaceuticals Friday, one of the sponsors of the proposed bill said Thursday.

"It will be the first reading of a bill to create a new statute in the legal code covering the manufacture, intent to supply, supply, storage, transportation and importation of counterfeit pharmaceuticals," said Pyotr Shelishch, a member of the Duma's Legislation Committee.

Counterfeit medicine is a serious problem on the Russian market, Shelishch said.

"It's difficult to say what the amount of counterfeit drugs is, but estimates range from fractions of a percentage up to 10 percent," he said. The country's pharmaceutical market is worth around $10.7 billion, according to estimates by industry consultant Pharmexpert

According to the new proposals, the minimum penalty would rise to 500,000 rubles ($20,000) and the maximum penalty would be a 15-year prison term, Shelishch said.

"The maximum sentence would be applicable if it led to the deaths of two or more people," he said.

The new measures come as a result of glaring shortcomings in existing legislation, lawmakers and analysts said.

"I welcome this new move, as we still do not have any law to punish those people that produce counterfeit drugs in Russia," said Nikolai Demidov, general director of Pharmexpert.

In November, pharmaceuticals firm Bryntsalov-A was handed a 40,000 ruble fine after being found guilty of offenses including the improper storage of drugs.

Manufacturers welcomed the proposed legislation but said new laws needed to be backed up by tougher action. "Any changes in legislation should be followed by relevant enforcement measures. Legislative amendments are meaningless without strong support of control activities from executive authorities," a GlaxoSmithKline Russia spokesman said.

"We would like to see examples being made where those found to knowingly trade in counterfeit medicines are prosecuted and receive meaningful penalties," the spokesman said. "We would also like to see an increase in checks on pharmacies and warehouses."

With international standards such as the good manufacturing practices code as yet not obligatory in Russia, Demidov said overall production control needed to be sharpened.

The prevalence of counterfeit medicine in the country has consistently been one of the major factors hampering Russia's entry into the World Trade Organization.

"Of course we are thinking first of all about our citizens, but if these measures help facilitate Russia's entry into the WTO, then that is also positive," Shelishch said.

The urgency of these requirements makes it likely that the legislative changes will be passed by the end of the year, Demidov said.

"I hope that this law will be adopted not later than September. I am linking this with the WTO membership bid," he said.

It's a good start, but the Russian government can still Duma. (Get it.)

Another story in the WSJ today about a "study" about conficts in medicine cooked up by people who have conflicts themselves, at least in the way they define conflicts. Blumenthal and Rothman's IMAP gets money from the liberal Soros whose drug companies aggressively marketed testosterone products off-label and works with Community Catalyst, which rakes in money suing drug companies through its Prescription Drug Access Litigation Project.


At least the story gets in one good quote from Tom Stossel who said it best ""If a physician can be influenced into prescribing certain drugs just because he had pizza with a pharmaceutical guy, then it's the fault of his training and not the drug company." Or his or herself.

In general, if I had a choice of doctors being "influenced" by pizza deliveries from drug reps or trial attorney funded front groups...guess which one I would choose?

Make that a pie with extra cheese.

http://content.nejm.org/cgi/content/full/356/17/1742

America's Health Insurance Plans that the Center for Medicare and Medicaid Services be “given explicit authority by Congress to us available data on comparative effectiveness and cost-effectiveness in determining in coverage policies. Similarly CMS should be empowered to set its reimbursement rates for new technologies more in alignment with added (for marginal) value of a new technology over established alternatives.“

AHIP's Steve Pearson claims that NICE cost effectiveness decisions have a high level of acceptance by physicians which are due in large part to the "very early and explicit attention to the quality of the data they use. NICE has earned a well-deserved reputation for methodological rigor, transparency, and an ability to learn."

http://www.cmwf.org/publications/publications_show.htm?doc_id=252181

Read Peter's post for a reality check.

AHIP is sucking up to the D's in Congress plain and simple. And it is working with the Commonwealth Fund to enact rationing of new medicines and devices (check out what AHIP wants the FDA to do on new device and diagnostic regulation!)

I thought AHIP had more sense and compassion. You can read the whole report that calls for the creation of a NICE like entity in America here:

http://www.ahip.org/content/pressrelease.aspx?docid=19476

There is an old joke about the definition of chutzpah being someone who kills his parents and then asks for mercy from the judge because he's an orphan.

Now we have the journalist equivalent. Alex Berenson has an article in today's NYT: "US Wonders If Drug Data Was Accurate." You might recall Berenson helped ferret documents in violation of a court order to help build a biased case against Eli Lilly about well known side effects about Zyprexa and who was slammed by Judge Harvey Weinstein for doing so. And now he is writing about Zyprexa using the same documents he stole. Once again, Berenson uses the "one paper out of several thousands of documents" approach to depict Lilly as a criminal corporation.

And then at the end of the article Berenson writes: "A federal judge has criticized The Times for violating a protective order that covered the documents."

C'mon Alex we can be more accurate. We have the actual transcript describing YOUR behavior without violating the protective order. Didn't Judge Weinstein describe what you did as conspiring " to obtain and publish documents in knowing violation of a court order not to do so, and that they executed the conspiracy using other people as their agents in crime."

And as another report noted, Weinstein further described the actions of the men as "illegal," "stealing," a "brazen flouting" of his order and, in the case of Berenson, "reprehensible." He took occasion to quote from a 2004 version of the Times' handbook on ethical journalism: "Staff members must obey the law in pursuit of news."

On the heels of intense criticism of the NYT coverage of the Duke rape case and the paper's falling earnings, the Berenson reporting is another example of the Times decline.

The FDA announced today that all supplements and products derived from kryptonite would have a black box warning. Dr. David Graham had pressured the agency after noting that the presence of kryptonite would pose a serious and life threatening danger to Superman, Supergirl and other survivors of the planet Krypton. Graham had been pushing Congress to expand it's drug safety program to move beyond "merely planetary surveillance activities" and into galactic exploration of pharmacovigilance matters. The FDA said in a press release " this pilot project is part of our effort to develop a global and indeed galactic risk management program." The agency had planned to establish this program in partnership with Luthor Industries and the Justice League of America but was attacked by members of Congress for being too "cozy" with special interests.

Again, I am not making this up.....

New breakthrough research demonstrates for the first time that spending 5 minutes with a drug rep alters the subconscious mind of doctors in subtle ways, causing them to prescribe drugs that no one really need or wants or even uses.

The survey of 116 visits to 97 doctors found that after a five minute "session" with a drug rep, doctors were 46 percent more likely to prescribe a drug or recommend it to their colleagues.

One of the author's of this groundbreaking study, Dr. Michael Steinman of the San Francisco Veteran's Affairs Hospital said: "The remarkable thing is how effective a very brief visit by a drug representative -- most often less than five minutes -- can be in influencing physicians' choices to use a drug for an unapproved indication,"

Besides free drug samples, salespeople often bring gifts, lunch for the doctor or office staff, new pens and coffee mugs. "The doctor feels subtly, even subconsciously, indebted to the representative," Steinman said.


The study appears in the April 24, 2007 issue of PLoS Medicine. Co-authors of the study were G. Michael Harper, MD, Mary-Margaret Chren, MD, and C. Seth Landefeld, MD, of SFVAMC and UCSF.

Steinman, Landefeld, and Chren served as unpaid expert witnesses for the plaintiff in the litigation from which the source data for the study was obtained.

What a surprise.

The study was supported by funds from the Veterans Health Administration, the National Institute on Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the John A. Hartford Foundation, and the California Tobacco-Related Disease Research Programs.

What is government money doing supporting such crap?

The Thai dictatorship clearly has Abbott in is sights. Working hand in glove with NGOs it clearly picked a fight over the price of its HIV drugs to distract attention over the suspension of civil liberties. It is disturbing to see Oxfam -- which boycotts Israel over so-called human rights abuses -- working with Thailand's military junta to demonize drug companies yet again and get away with it. But that is how the media and most of the world sees things. So ultimately Abbott had no choice but to cave, at least for now.

Long term, drug companies need to rethink their approach to emerging markets. Time and the wealth are on the side of innovation and property rights, not the thugs and NGOs who prop them up. They would do well to increase investment in global health policy, entrepreneurship in middle markets, and support partnerships with people interested in delivering new products throughout the world at market relevant prices.