Al Capone and the FDA

04/30/2007 07:26 AM |

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?  Read More & Comment...

Randy Tobias

04/30/2007 06:03 AM |

The pun couldn't be more perverse or the message more clear -- men in high public office need to keep it zipped. The fact that Mr. Tobias represented our nation on AIDS issues (like abstinence) makes this even more unfortunate. Who vetted this guy anyway? On a personal note, I served on a United Way of Indiaia committee with Tobias when he was at the helm of Eli Lilly. Hs good works were well known. But now he will be remembered for other, less noble deeds. Shameful.  Read More & Comment...

Just say "Nyet"

04/27/2007 04:31 PM |

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.)  Read More & Comment...

Real EBM: Genes Predicting Type-2 Diabetes Identified

04/26/2007 03:39 PM |

"We have the possibility of getting a very, very powerful predictive test that measures your risk of developing type 2 diabetes," said Dr. Kari Stefansson, president and CEO of Icelandic company deCODE genetics Inc.

Meanwhile AHIP wants the FDA to impose more costs and regulation to get approval of such predictive tests but proposes spending $8 billion a year to make one size fits all recommendations on which diabetes drugs Medicare should pay for.  Read More & Comment...

Another Conflicted "Study" About Conflicts

04/26/2007 07:09 AM |

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  Read More & Comment...

Blame It On Rio: Brazil Threatens Merck On HIV Drug Prices

04/25/2007 03:07 PM |

Brazil is now demanding that Merck lower the price for its HIV drug Efavirenz to what it is being sold in Thailand. (From $1.59 to 65 cents) If Merck does not agree (which it will) then Brazil's health minister will seek a compulsory license for the drug.

Again, unless companies come up with a long term strategy to deal with pricing in emerging or middle markets, NGOs will continue to use the CL route to ratchet down the price of ALL medicines.

No way to run a business.  Read More & Comment...

AHIP is not very NICE

04/25/2007 02:55 PM |

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  Read More & Comment...

Comparative Reflexiveness

04/25/2007 08:33 AM |

Whether it’s said in an American accent or a more refined British one, what's most important is to accent the truth – comparative effectiveness is bad medicine when you use healthcare technology assessment (HTA) tools (aka "Evidence-based Medicine") that misuse and misrepresent data derived from RCTs. Doing so yields results that budget managers want – regardless of whether or not it yields what’s best for the patient.

It’s the choice of short-term, short-sighted politicians.

Consider what’s going on in the UK.

The Association of the British Pharmaceutical is fighting proposals by the Office of Fair Trading to overhaul the pharmaceutical price regulation scheme so drugs companies will be forced to evaluate the benefit to the patient and the National Health Service when they set the prices.

Richard Barker, ABPI director-general, called the OFT's proposals "dangerous and anti-innovative". "The OFT has failed to understand the nature of scientific progress is step by step," he said, arguing that without a commercial incentive to introduce incremental improvements, more significant breakthroughs in new medicines would not take place.

He said the industry's two principal demands were to enhance the methods used for "health technology assessment", which would scrutinize the efficacy and cost benefits of new medicines; and to boost the often poor "uptake" of new medicines recommended by the National Institute for Clinical Excellence, the medicines advisory body.

His comments came ahead of hearings set to begin in the coming weeks by the Commons' health committee on the operation of the institute, which is studying why the agency's decisions are increasingly being questioned and whether public confidence in the organization is waning.

MPs will discuss the evaluation process and whether any particular groups are disadvantaged by the process, the speed of publishing guidance, the appeal system, comparison with the work of its Scottish counterpart, and implementation of its guidance.

Here’s the full story from the Financial Times:

http://www.ft.com/cms/s/88cd12b8-f2c8-11db-a454-000b5df10621.html  Read More & Comment...

We Wonder If Alex Berenson Was Ever Accurate

04/25/2007 07:59 AM |

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.  Read More & Comment...

FDA Panel Approves New Personalized Medicine for HIV

04/24/2007 10:07 PM |

Pfizer's New combo drug-diagnostic for HIV got through the FDA Adcomm... I still wonder what prompted the FDA to dump all the safety concerns ahead of the commitee meeting?

http://blogs.wsj.com/health/2007/04/24/pfizer-aids-drug-gets-fda-panel-support/  Read More & Comment...

Real Kryptonite Found: FDA Puts Black Box Warning on Related Products

04/24/2007 03:40 PM |

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.  Read More & Comment...

First, do no harm ... to seniors

04/24/2007 01:46 PM |

When it comes to what this Congress is trying to do to the public health, we refuse to sit by and take a postion of, er, non-intereference.

Here's a new piece from today's edition of the Chicago Tribune:

http://www.chicagotribune.com/news/opinion/chi-0704230346apr24,0,7088012.story?coll=chi-newsopinioncommentary-hed

Hopefully some prominent Chicago officials (like Barack Obama and Rahm Emanuel) will see this and see the light. But we'll keep our expectations realistic and just hope they see it.  Read More & Comment...

New Study Finds Doctors Subconscious Altered By Drug Reps

04/24/2007 11:28 AM |

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?  Read More & Comment...

FDA's Superior Attitude

04/23/2007 10:12 AM |

Download file

Here's a link to Steve Usdin's superior article on FDA's Arcoxia attitude:  Read More & Comment...

Abbott's About Face on AIDS Drug Pricing

04/23/2007 09:08 AM |

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.  Read More & Comment...

Disturbia: FDA's Sneak Attack on Maraviroc

04/23/2007 08:35 AM |

AP's Andrew Bridges reports today that

" Health officials repeated safety concerns about an experimental group of HIV drugs Friday, days before government advisers will recommend whether the first drug from the class merits approval.

Pfizer Inc. seeks Food and Drug Administration approval for maraviroc, potentially the first in a novel group of drugs to fight HIV, the virus that causes AIDS. Pfizer proposes marketing maraviroc as Celsentri.

Pfizer believes there is a clear unmet need for new drugs to fight HIV in patients for whom other, older drugs no longer work. Celsentri is unlike any other HIV medicines now on the market in that it targets the cells of patients and not the virus itself.

The FDA has scheduled a Tuesday meeting of outside experts to discuss Pfizer's application for approval. The FDA has asked the experts whether Celsentri, if approved, would require special labeling or if further study of the drug's safety is needed before it can be sold. FDA also asked whether the drug should be studied further in women and blacks."


Is this a strategic attempt to get the "bad news" out ahead of the Adcomm meeting or an effort to scuttle the drug in order to avoid looking bad? CCR5 inhibitors have been associated with an increased risk of liver damage and lymphoma but I don't know what that risk is relative to other drugs such as tylenol or other viruses left untreated. More worrisome perhaps: Maraviroc not only targets specific cells, but it will be marketed with a protein assay that will identify which patients that are high responders. Personalized medicine. Which means that the risk benefit profile will be higher still. I don't get this need for studying African Americans and women when you have a genetic test. Why not study Ashkenazic Jews still suffering from last night's Yankee game who live in New Jersey while your at it?

A first in class personalized medicine for a fatal disease and still the agency is screwing around with safety issues. Just how high does the bar have to be to get a drug approved?  Read More & Comment...