What time is it at the FDA?

06/29/2007 08:40 AM |

Whichever party wins the White House in 2008, one truth will prevail at FDA – regulators love ambiguity but can learn to embrace predictability.

A second truth is that FDA decisions are and will continue to be based solely on sound science and its impact on the public health. So, whether red or blue is ascendant, FDA will make its decisions based on the facts.

What might change, depending on who occupies the White House and the FDA Commissioner’s Office, is how the FDA views the concept of time. And it could go either way --because there is real time and there’s FDA time.

There’s an old Washington story that goes like this -- Henry Kissinger asked Chinese leader Chou En Lai whether the French Revolution of 1789 had benefited humanity, to which Chou responded: "It's too early to tell."

Chou would have made a great regulator.

Real time is for the world we live in. The clock we watch – for business, certainly, but also for the rest of us. FDA time is the time it takes to get it right (PDUFA notwithstanding) and, unless there's a trebling of the FDA budget, the only real way to meaningfully accelerate FDA actions without compromising quality (read “safety and effectiveness”) is through collaboration with academe, with industry, and with hybrids like Ray Woosley's Critical Path Initiative.

Will collaboration continue to be embraced by the next President? By the next FDA Commissioner? This is the crucial question.

A related core issue is predictability – the opposite of ambiguity.

Predictability is power in pursuit of the public health. A case in point is the Critical Path initiative and the ways it can reach out and work with non-government partners via the imminent Reagan-Udall Center (pending in still pensile legislation). But ambiguity is bureaucratic power – and too many regulators accept ambiguity as a replacement for responsibility..

(I also believe that too many folks at pharmaceutical companies accept ambiguity as a replacement for responsibility.)

The coming election, relative to the future of the FDA, is a battle between nascent predictability and insidious ambiguity. So, here’s my idea for a bumper-sticker – “I support the FDA and I vote.”  Read More & Comment...

That's SMOKED Salmon

06/28/2007 05:58 PM |

Someone with a twisted mind came up with this headline at CNN.com..

FDA bans import of drugged fish from China
Food and Drug Administration announced a ban on the import of five species of seafood from China due to possible contamination with medications.

http://http://money.cnn.com/2007/06/28/news/international/china_fish/?postversion=2007062815  Read More & Comment...

Michael Moore's Sick Message

06/28/2007 01:27 PM |

My prescription: Go see "Live Free and Die Hard" instead.

Read article here
  Read More & Comment...

The Whack Pack's Perverse Priorities on Drug Safety

06/28/2007 08:18 AM |

You have to love the way the NEJM and the NY Times treat the issue of drug safety. Steve Nissen runs a crappy meta-analysis of Avandia's supposed dangers and it's rushed to e-print in advance of a Senate hearing and the close of the markets. The NYTmakes it front page news.

A careful study that shows a very low risk of birth defects among women taking anti-depressants while pregnant...? Why, the very same NEJM sees no reason to stop the presses. No Congressional hearings. No publicity whores running to Nightline to talk about the number of suicides and depressed women who affected by the lack of treatment.

And the NY Times? No front page articles linking anti-depressants to "suicides." Because this time it's for real and this time it's a case of telling pregnant women it's ok to take them. (Kudos to http:// pharmalot.com for being one of the first on the web with the good news)

It's page A16, next to a silly story about a congressional proposal setting up a mandatory registry of all "gifts" drug companies provide to doctors. Listen to how the NY Times reports on this NEJM article:

The findings, appearing in two studies in The New England Journal of Medicine, support doctors’ assurances that antidepressants are not a major cause of serious physical problems in newborns.

"But the studies did not include enough cases to adequately assess risk of many rare defects; nor did they include information on how long women were taking antidepressants or at what doses. The studies did not evaluate behavioral effects either; previous research has found that babies suffer withdrawal effects if they have been exposed to antidepressants in the womb, and that may have implications for later behavior.

“These are important papers, but they don’t close the questions of whether there are major effects” of these drugs on developing babies, said Dr. Timothy Oberlander, a developmental pediatrician at the University of British Columbia, who was not involved in the studies. “There are many more chapters in this story yet to be told.”

http://www.nytimes.com/2007/06/28/health/28depress.html?_r=1&oref=slogin

Meanwhile, in responding to a similar study last year Oberlander said: "At present, probably the effect of not treating the women's clinical depression is a much bigger issue for mothers and their infants."


http://www.healthfinder.gov/news/newsstory.asp?docid=530794

Maybe we should do a study looking at the effect of being interviewed by the NYT on the quotes researchers give to reporters. We could call it the Nissen Doomsday Effect.


I digress. Notice all the caveats? Now here's the NYT on Avandia:

"The analysis, based on a review of more than 40 existing clinical studies involving nearly 28,000 patients, showed that Avandia significantly increased the risk of heart attacks, compared with other diabetes drugs or a placebo.

Both the study’s lead author and the editors of The New England Journal of Medicine, in which the article appeared, cautioned that the research method used left the findings open to interpretation. But they said the study nevertheless raised important concerns.

And the publication of the study on the journal’s Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.

The journal’s editor in chief, Dr. Jeffrey M. Drazen, said: “We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug.”

http://www.nytimes.com/2007/05/22/business/22drug.html?pagewanted=1&ei=5070&en=dacbc8e498ef3c7d&ex=1183176000

No bias in the media on drug safety. None at all. In light of the increase in teen suicide due to a decline in SSRI use which was triggered by biased reporting, makes you wonder what would happen if drug companies weren't around to provide responsible, peer-reviewed and regulated information about the benefits of their products. And I AM serious about that.  Read More & Comment...

The Sludge Report: More Mewlings From Peter Rost

06/27/2007 06:03 PM |

Lest anyone be uncertain that Peter Rost is not a small-minded person who blogs without regard to the totality of the facts, here is the context of Rost's gleeful pursuit of Pfizer's renewed effort to market Viracept, an "old drug" as the consistently vindictive and inaccurate Rost calls the HIV medicine.

Pfizer, according to Rost, was quick to launch marketing materials regarding Viracept. It's materials were not issued and released INTERNALLY consisted with it's own guidelines and the release was shut down. Therefore Rost cannot contain his glee at the expense of the former employe whom he drew a no-show salary from to the tune of over $600K a year while suing them.

But here are some relevant facts, perhaps, just perhaps.
1. The World Health Organization (WHO), drug companies, drug regulators, NGOs and national governments have been working together to minimise the disruption of antiretroviral therapy to individuals affected by the near-global recall of nelfinavir (Viracept).

Although it was initially thought that the recall only affected Europe following the alerts issued by Roche, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMEA) on June 6 th, it has, in fact, affected every country in the world with the exception of the United States and its territories, Canada and Japan.

"A very difficult situation"
On June 14th, WHO issued a statement on the recall, saying that "Roche informed WHO on 8 June 2007 of its global recall of its nelfinavir products (Viracept)." Roche estimates that around 45,000 individuals are affected by the recall globally.

Roche’s International Communications Manager for HIV and Hepatitis, Janet Kettels told aidsmap.com: "This is obviously a very difficult situation, as many people living with HIV/AIDS in the least developed countries do not have easy access to a wide range of alternative treatments."

http://www.aidsmap.com/en/news/EFA4601B-2827-4131-B2E8-6EB722BEE1D9.asp

2. Roche is in Talks With Pfizer Over Viracept Supply Following Recall
As Roche corrects a manufacturing error that resulted in a recall of all batches of its HIV treatment Viracept sold in the European Union (EU) and other world markets, the company is in discussions with Pfizer to supply the antiretroviral as a potential option in expediting the market return of the product, Roche told DID June 20.

www.aidsmap.com

Here's a link to the sludge report.... http://peterrost.blogspot.com/  Read More & Comment...

Pharmonic Convergence

06/27/2007 12:41 PM |

Two interesting stories today that both reach the same place -- we need to find ways to get the right medicines to the right people at the right time in the right dose. Let's call it "Pharmonic Convergence."

First story comes from the Pink Sheet and their discussion of FDA's genetic test guidelines.

As reporter David Filmore writes vis-a-vis the FDA's genetic test guidelines:

"The agency drafted the guidance document on pharmacogenetic tests and genetic tests for heritable markers to help shorten development and review times for these products, which are attracting growing attention from the medical community as tools to make more precise disgnoses and, in the case of pharmacogenetic tests, more personalized treatment decisions."

Right now, today such tests exist. It is not, as many will derisively tell you, science fiction. It's science fact. And the fact that most insurance companies don't reimburse for such diagnistic tools is short sighted.

To that point, an article from today's New York Times. Gray Lady scribe Milt Freudenheim reports on a new study by the Integrated Benefits Institute that shows, "Employers that shift too much of the cost of drugs to workers in their company health plans could wind up losing more than they save, through absenteeism and lost productivity, according to a study by health policy researchers."

"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.

As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."

The lede of the New York Times article reads, "Health penny wise, medical pound foolish?

Indeed.

Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payors interpose themselves between doctor and patient, when prescribing decisions are made by accountants (read "evidence-based medicine"), health outcomes decline for the individual and costs go up for the payor.

Let's keep our eye on the prize as we strive to move from acute to a chronic care model for 21st century health care. It's nothing short of critical.

And, after all, that's why we have the Critical Path.  Read More & Comment...

Measure THIS!!!

06/27/2007 10:59 AM |

While the comparative effectiveness cabal try to turn patients into cost-centers and forget that you and I real live human beings, the Integrated Benefits Institutes releases a study that brings the human element back to the delivery of healthcare:

"New Integrated Benefits Institute Report Finds Pharmaceutical Cost Shifting Leads to Increased Disability and Lost Productivity


San Francisco – June 27, 2007 – Medical costs, including drug expenditures, have continued to rise much faster than the rate of inflation, causing employers to use strategies to control costs for pharmaceuticals including higher copays, tiered benefit plans and higher deductibles. A new report released today by the nonprofit Integrated Benefits Institute (IBI) reveals that shifting costs to employees doesn’t save employers money and discourages treatment essential to employees’ health-related productivity and quality of life."

Here's a key quote that all the cost-containers in Washington and those who want to set up a comparative effectiveness board should staple to their forehead, carefully, so all the air doesn't escape:

“As employers understand that providing effective, available health care is an investment in human capital that will pay off in real dollars by decreasing overall health-related costs, they may want to rethink their approach to measuring and investing in employee health and productivity,” said Jack Mahoney, MD, medical director at Pitney Bowes. “This is not only good for employers, but employees can benefit from less shifted costs and better health and quality of life.”

Exactly. Dr. Mahoney articulated the humane, patient centered approach to medicine that the Beltway/Health Affairs/Kaiser/Commonwealth types have turned their backs on. Health care is a human and humane enterprise, not a rationing activity.

Thanks to IBI for restoring a moral and medical compass to the discussion of health care policy.

http://www.ibiweb.org/news/articles/display/7025  Read More & Comment...

The Right Way to Boycott Israel

06/27/2007 10:28 AM |

From the Daily Sport in the UK

SUBJECT: IF YOU'RE GOING TO BOYCOTT ISRAEL - DO IT PROPERLY!

OK. So I understand that you are ticked off at Israel, and in love with
the Palestinians. That's fine with me, as long as you have truly
weighed all the facts.

So, you want to boycott Israel????? I'll be sorry to miss you, but if
you are doing it - do it properly. Let me help you.

An Israeli company has developed a simple blood test that
distinguishes between mild and more severe cases of Multiple
Sclerosis. So, if you know anyone suffering from MS, tell them to
ignore the Israeli patent that may, more accurately, diagnose their
symptoms.

An Israeli-made device helps restore the use of paralyzed hands. This
device electrically stimulates the hand muscles, providing hope to
millions of stroke sufferers and victims of spinal injuries. If you
wish to remove this hope of a better quality of life to these people,
go ahead and boycott Israel.

Young children with breathing problems will soon be sleeping more
soundly, thanks to a new Israeli device called the Child Hood. This
innovation replaces the inhalation mask with an improved drug delivery
system that provides relief for child and parent. Please tell anxious
mothers that they shouldn't use this device because of your passionate
cause.

These are just a few examples of how people have benefited medically
from the Israeli know-how you wish to block. Boycotts often affect
research.

A new research center in Israel hopes to throw light on brain
disorders such as depression and Alzheimer's disease.

The Joseph Sangol Neuroscience Center in the Sheba Medical Center at
Tel HaShomer Hospital, aims to bring thousands of scientists and
doctors to focus on brain research.

A researcher at Israel's Ben Gurion University has succeeded in
creating human monoclonal antibodies which can neutralize the highly
contagious smallpox virus without inducing the dangerous side effects
of the existing vaccine.

Two Israelis received the 2004 Nobel Prize in Chemistry. Doctors
Ciechanover and Hershko's research and discovery of one of the human
cells most important cyclical processes will lead the way to DNA
repair, control of newly produced proteins, and immune defense
systems.

The Movement Disorder Surgery program at Israel's Hadassah Medical
Center has successfully eliminated the physical manifestations of
Parkinson's disease in a select group of patients with a deep brain
stimulation technique.

For women who undergo hysterectomies each year for the treatment of
uterine fibroids, the development in Israel of the Ex Ablate 2000
System is a welcome breakthrough, offering a noninvasive alternative
to surgery.

Israel is developing a nose drop that will provide a five year flu
vaccine.

These are just a few of the projects that you can help stop with your
Israeli boycott. But let's not get too obsessed with my ducal
research, there are other ways you can make a personal sacrifice with
your anti-Israel boycott.

Most of Windows operating systems were developed by Microsoft-Israel.
So, set a personal example. Throw away your computer!
Computers should have a sign attached saying Israel Inside. The
Pentium NMX Chip technology was designed at Intel in Israel. Both the
Pentium 4 microprocessor and the Centrum processor were entirely
designed, developed, and produced in Israel.

Voice mail technology was developed in Israel.
The technology for the AOL Instant Messenger ICQ was developed in 1996
in Israel by four young Israeli whiz kids.

Both Microsoft and Cisco built their only R. & D. facilities outside
the US in Israel.

So, due to your complete boycott of anything Israeli, you can now
have poor health and no computer.

But your bad news does not end there. Get rid of your cellular phone.
Cell phone technology was also developed in Israel by MOTOROLA which
has its biggest development center in Israel. Most of the latest
technology in your mobile phone was developed by Israeli scientists.

Feeling unsettled? You should be. Part of your personal security rests
with Israeli inventiveness, borne out of our urgent necessity to
protect and defend our lives from the terrorists you support.

A phone can remotely activate a bomb, or be used for tactical
communications by terrorists, bank robbers, or hostage-takers. It is
vital that official security and law enforcement authorities have
access to cellular jamming and detection solutions.
Enter Israel's Net line Communications Technologies with their
security expertise to help the fight against terror.

SO ALL THE NOISE ABOUT THE USA LISTENING TO OUR PRIVATE TELEPHONE
CALLS, YOU SHOULD KNOW IT IS ISRAEL WHO IS DOING THE LISTENING FOR US.

A joint, nonprofit, venture between Israel and Maryland will result in
a 5 day Business Development and Planning Conference next March.
Elected Israeli companies will partner with Maryland firms to provide
innovation to the US need for homeland security.

I also want you to know that Israel has the highest ratio of
university degrees to the population in the world.

Israel produces more scientific papers per capita - 109 per 10,000 -
than any other nation.
Israel has the highest number of startup companies per rata. In
absolute terms, the highest number, except the US. Israel has a ratio
of patents filed.

Israel has the highest concentration of hi-tech companies outside of
Silicon Valley. Israel is ranked #2 in the world for venture capital
funds, behind the USA.
Israel has more museums per capita.

Israel has the second highest publication of new books per capita.

Relative to population, Israel is the largest immigrant absorbing
nation on earth.

These immigrants come in search of democracy, religious freedom or
expression, economic opportunity, and quality of life.

Believe it or not, Israel is the only country in the world which had a
net gain in the number of trees last year.

Even Warren Buffet of Berkshire-Hathaway fame has just invested
millions with Israeli Companies.

So, you can vilify and demonize the State of Israel. You can continue
your silly boycott, if you wish. But I wish you would consider the
consequences, and the truth.

Think of the massive contribution that Israel is giving to the world,
including the Palestinians - and to you - in science, medicine,
communications, security.

Pro rata for population, Israel is making a greater contribution than
any other nation on earth.  Read More & Comment...

Truthspeak on Importation

06/26/2007 03:28 PM |

Peter's post on his importation briefing is Kafka-esque. You can't make up the kind of rationalizations the pro-importation forces have been reduced to -- because they are driven by polls and pure political objective, not facts, not reason, not concern for public health or safety. I think official Washington has created and thrives on a new form of communication, Truthspeak, where flacks, spin doctors, policy hatchets, et al., will say and do anything that advances their short term interests and/or protects their flank though it may contradict reality or what was said or done the day before. The past -- what once was history -- no longer exists and therefore one is no longer accountable or responsible for deeds or actions other than those in the very present.

This tactic has spread Ebola-like throughout politics as the number of media outlets needing content on a 24/7 basis have multiplied.

The importation forces are lead, not coincidentally by Truthspeaker-in-Chief Rahm Emanuel who turned parsing phrases and weasel words into lethal political weapons for the Clintons. (He's had much less success in helping his buddy, Illinois Governor "Wrong-Way Rod" Blagojevich, have any success in the Prairie State's ill-fated importation schemes.)

If you can convince people to open the US to unsafe practices that don't even save money in Europe -- you can do anything. Well, we hope not.   Read More & Comment...

Lies. Damn Lies. And Drug Importation

06/26/2007 08:27 AM |

Just because you say it enough times doesn't make it true.

Most recent example that proves this maxim is the attempt by certain members of Congress -- in this case U.S. Representatives Rahm Emanuel (D-IL), Jo Ann Emerson (R-MO), Rosa DeLauro (D-CT), and Marion Berry (D-AR) -- to hide the facts that drug importation is neither safe nor smart.

The Fearsome Four offer the following reasons why drug importation is a good idea. (We offer the facts in bold -- because the truth must be told boldly.)

The Fearsome Four claim that the same brand name drugs cost 35-55% less in other nations then they do in the US.

That's because the nation's of the EU (and Canada) have price controls that equal choice controls for their citizens. Also, the rest of the world unfairly shirks its responsibilities to shoulder their fair share of the burden of research and development. This is what members of Congress should be up in arms about.

The Fearsome Four say that drug importation has been in place in the European Union (where they call it "parallel trade") for more than 20 years with no safety problems.

Believe it or not, their "source" for this is Peter Rost. For the truth we prefer the European Commission who has identified parallel trade as the weak link in the chain for counterfeiters. It's also convenient (although not responsible) to forget that the British regulatory authorities have recently found counterfeit and substandard medicines in their island kingdom -- courtesy of parallel trade.

The Fearsome Four claim the pharmaceutical industry has imported drugs and sold them in the U.S. for decades. In fact, 40 percent of the drugs consumed by Americans today are made in foreign manufacturing plants.

That's right -- in plants authorized and inspected by the FDA. The Four conveniently omit the fact that their legislation would allow in medicines from plants not approved by the FDA. Oops.

The Fearsome Four claim that prescription drug importation will result in $50 billion in direct savings alone over the next decade, a $10 billion benefit to the federal budget.

For this fact they cite a Congressional Budget Office Study. But what the study actually says is that such a program woyuld reduce the drug spend in the US by .01%. And that doesn't include the monies needed to set up an entirely new, international system for drug regulation.

And finally, the Fearsome Four claim that passage of the Pharmaceutical Market Access and Drug Safety Act will finally assure the security of our drug supply.

Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few. Because what the Fearsome Four aren't saying is that "drugs from the United Kingdom" means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere. They should do their homework.

What happens when pesky facts get in the way of political grandstanding? Good things.  Read More & Comment...

AMA Protects Itself Against Competition

06/25/2007 12:43 PM |

For those of us who enjoy waiting two hours in a doctor's office or using the ER room to getting care because we don't get sick between 10-5, you'll love how the AMA is responding to the grow of retail health clinics:

The American Medical Association should call for a ban on in-store clinics being opened by retail giants like Wal-Mart Stores Inc. and Walgreen Co., several doctors groups urged at the AMA's annual meeting in Chicago on Sunday.

Faced with an onslaught of competition that is forecast to bring several thousand retail health clinics to U.S. consumers, AMA members testified that such clinics are endangering patient care, particularly for children. The doctors say the clinics, largely staffed by advanced-degree nurses and physicians' assistants, are largely unregulated and, therefore, put patients' health at risk.

I have used the Redi-Clinics at Duane Reade and I can tell you MY health was put at risk. I was nearly knocked unconscious by how clean, convenient and excellent the care was. A PA whose previous experience was working at a community health center provided me a flu shot and quick look at my sinuses. She sent a copy of my record via email to me which I shared with my physician. Yeah, a real risk alright.

"There is no more urgent issue than this for the AMA," Dr. Kamran Hashemi, a family physician from South Barrington, said, urging the organization to push for more regulation of retail clinics. "This issue speaks to what all of us do every day in practice." If the AMA does nothing, Hashemi said, "in five years, the chairs [at the AMA] meeting will be filled with representatives from Walgreens, Wal-Mart" and other retail outlets.

It's called competition, Kamran. Get off your chair, change or get out of the way. People in rural areas, who work real jobs, who have sick kids need access to real care in real time, not when it's convenient to doctors who are interested in the status quo. Protectionism is not going to cut it.

http://www.chicagotribune.com/business/chi-clinics_bizjun25,0,4533626.story?coll=chi-business-hed  Read More & Comment...

WeLLO

06/25/2007 08:35 AM |

As its costs continue to spiral upward, most people now agree that America's health care system is broken. And as the race for the White House heats up, politicians on both sides of the aisle are clamoring to propose ideas that rein in health spending.

Unfortunately, the policies offered thus far are misguided. As counterintuitive as it may sound, the answer to America's health care woes won't be found by harping over the price of care.

Here's the rest of the story via a new op-ed in the Baltimore Sun:

http://www.baltimoresun.com/news/opinion/oped/bal-op.prevention24jun24,0,2342454.story?coll=bal-oped-headlines

The conclusion?

"Prevention must be health care's first line of defense, as a proper diet and healthy lifestyle can stop many diseases in their tracks.

Failing prevention, earlier diagnosis and care are crucial. There are many effective treatments and maintenance medications that can stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives without breaking the bank.

In the coming weeks, the nation will learn more about the health care plans of each of the major presidential candidates. If lawmakers want to save lives, enhance the quality of care, and reduce costs, the focus needs to shift to prevention and early diagnosis."

SiCKO? How about WeLLO.  Read More & Comment...

Interesting Avandia Posts

06/22/2007 04:57 PM |

Looks like you have to step away from the pharma bloggersphere to find a Kool-aid free zone on Avandia and Nissen:

From http://10qdetective.blogspot.com/

https://www.blogger.com/comment.g?blogID=19852159&postID=4016826588860183126  Read More & Comment...

FDA Supplemental GMP Regs: Slow Boat to China

06/22/2007 03:01 PM |

Thirteen years in the making...GMP requirements for supplements and herbal products.

From http://www.thetansheet.com

Dietary supplement manufacturers will have to be in compliance with newly issued – and long anticipated – dietary supplement good manufacturing practices by June 24, 2008, while the smallest firms will have until June 2010.

FDA posted the regulation for advanced display on the Federal Register June 22, thirteen years after the Dietary Supplement Health and Regulation Act authorized its creation.

The final rule "includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product," FDA notes. The rule also includes "requirements for recordkeeping and handling consumer product complaints."

The rule does not apply to suppliers or producers of raw ingredients, but instead places the onus of GMP compliance completely on manufacturers.

While the rule applies to dietary supplements and not dietary ingredients, any dietary ingredient used in a supplement product will be required to pass "100 percent" identity testing. Firms will be required to verify the identity of any components that are dietary ingredients, and confirm the identity of "other components."

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition. Under the final rule, manufacturers will be required to "evaluate the identity, purity, strength, and composition of their dietary supplements," the agency says. Supplements that contain contaminants or "do not contain the dietary ingredient they are represented to contain," would be adulterated or misbranded under the rule, FDA says.

Most of this stuff in made overseas or from material shipped overseas. As from China. No coincidence I'm sure. Now let's see how long compliance takes.  Read More & Comment...

State of Fear at the FDA

06/22/2007 02:43 PM |

What's up with the FDA issuing an approvable letter on maraviroc? Well according to Peter Rost (who should know since he is the master of manipulating golden parachutes for himself. Rost's next book: How To Collect Fat Paychecks From ShortHills By Suing Those You Work For) it was to allow outgoing Pfizer R and D execs to short their options. Yeah right. And all those imported drugs made in China ARE safe, just like the toothpaste and petfood.

Anyways, if you were an FDA drug reviewer you now have two choices: become a snitch for Senator Grassley or Congressman Waxman or simply wait till the very last minute to approve a drug. You never know when -- in the words of the owner of the Steven E. Nissen Healthy Heart Fund -- you might be approving another 9=11.

Maraviroc was a targeted therapy for people facing multiple drug resistant HIV...but hey, what's a few months while the FDA sorts out an even lower incidence of liver problems than Tylenol? We now live in a country where in some parts you have to be 19 to buy cold medicines with dextromethorphan. That's right folks, you can fight for your country but you can't buy Robitussin.

The infantilization of American continues apace.  Read More & Comment...

Conference Call

06/22/2007 09:52 AM |

By now you've surely heard that the E&C vote on the FDA reform package was 39-0 and full House passage looks good.

But ...

The House version has some very dangerous language vis-a-vis advisory committee conflict of interest waivers. The House bill would only permit the FDA to grant one COI waiver per committee.

One? Why not two? Or three? What's the difference? After all, each adcomm member needs to be dealt with as a discreet case, yes?

We can't allow FDA adcomms to be made up of the second best and the almost brightest. Not ever.

Hopefully this can be resolved in conference -- and in the best interest of the public health.  Read More & Comment...

Bookends

06/22/2007 08:09 AM |

"Old Friends. Old Friends. Sat on a park bench like bookends ..."

You know the song. Now have a look at our latest podcast, "Saul & Freddy." They're two senior citizens (ages 86 and 90) who we interviewed about health care while they were enjoying a beautiful sunny day -- and each other's company -- in New York's Central Park.

Here's the link (look under the "Podcasts" section):

http://www.cmpi.org

They're older ... but wiser. And politicians and pundits would be wise to heed their words.  Read More & Comment...

SiCKO and the Inconvenient Truth

06/21/2007 03:18 PM |

The New York Post's Sue Edelman reports that the Ground Zero responders Michael Moore took to Cuba because they couldn't get health care in America -- didn't get much care in Cuba.

Read here

Now the, er, inconvenient truth -- they were actually eligible for free health care under not one -- but at least three programs operating today.

The WTC Medical Monitoring and Treatment Program is a consortium of providers, including: Bellevue Hospital, Mt. Sinai Medical Center, Nassau County University Medical Center, Queens College Ground Zero Health Watch, SUNY-Stony Brook, UMDNJ-Robert Wood Johnson University Hospital, and other providers nationwide. Call (888) 702-0630 or (212) 241-1554, or visit www.wtcexams.org . Nearly 40 percent of the people being served by the program do NOT have health insurance and are receiving free care. Even if they worked for one day or a couple of hours at Ground Zero they are receiving care.

The Association of Occupational and Environmental Clinics (AOEC) is a non-profit organization that provides occupational health referrals in your area. Contact AOEC at 1010 Vermont Ave., NW #513, Washington, DC 20005, call (888) 347-2632 or (202) 347-4976, or www.aoec.org. New York State Occupational Health Clinic Network. For more information, contact your local occupational health clinic or the New York State Department of Health at (800) 458-1158, x7900 or (518) 402-7900, or visit www.health.state.ny.us/nysdoh/environ/occupate.htm .

We provide these links in the hopes that those in need get the care they deserve instead of the misinformation that will be fed to them in Sicko. Moore's movie does a disservice to the compassion and hard work of the caring professionals who actually improve the lives of 9-11 workers instead of exploiting them.  Read More & Comment...

Personalized Medicine vs Comparative Effectiveness

06/21/2007 03:11 PM |

I just finished reading all of the testimony and MedPac's recommendations about a comparative effectiveness commission. By the time everything is set up and they appoint all the people to run the commission (no doubt the very people who recommended it's creation) personalized medicine will have become very, very real. Or more to the point, since personalized medicine means the right medicine for the right person at the right time, why aren't we investing and supporting that since that is where the science and our biological reality exists? See the following article from the NY Times on how personalized medicine will make comparative effectiveness useless. We need personalized evidence of personalized medicine:

http://www.nytimes.com/2007/06/19/health/psychology/19beha.html?ei=5088&en=8af3ca746369c4db&ex=1339905600&adxnnl=1&partner=rssnyt&emc=rss&adxnnlx=1182453053-RSDs6n8k6574ORFf9+woIw  Read More & Comment...

Box Score: One hit. No errors.

06/21/2007 11:50 AM |

EMMA. If you liked the Cliff's Notes, you'll love the medical device.

FDA Clears 'Computerized Medication Box' for U.S. Market

The U.S. Food and Drug Administration has cleared for marketing the INRange Systems' Electronic Medication Management Assistant (EMMA), a programmable device that stores and dispenses prescription medication for patients' use in the home.

Essentially a computerized medication box, EMMA was designed to be used under the supervision of a licensed health care provider. EMMA can reduce drug identification and dosing errors, and allow health care professionals to monitor patient adherence to medication regimens in an outpatient setting. It may be especially useful for aging patients, as well as those with complex medication regimens such as patients with HIV.

"FDA's clearance of the INRange remote medication management system puts an important safety tool directly in the hands of patients and their health care providers," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "It will help take away some of the confusion patients can experience when taking prescription medications, and allow care providers to more closely monitor their patients' medications between office visits."

A 2006 Institute of Medicine report estimated that medication errors harm at least 1.5 million people in the United States annually.

EMMA consists of a medication delivery unit and two-way communication software that allows a health care professional to remotely manage prescriptions stored and released by the patient-operated delivery unit. The delivery unit is about the size of a bread box and plugs into a standard power outlet.

EMMA stores prescription medications, emits an audible alert to the patient when the prescribed medications are scheduled to be taken, and releases them onto a delivery tray when activated by the patient at the appropriate time. It uses a Web-based application for a health care professional, such as a doctor or pharmacist, to remotely schedule or adjust a patient's prescribed medications, and provides the health care professional with a history of each time patients access their medications.

FDA reviewed safety and effectiveness information for EMMA under the "de novo" classification process. The ability to petition for "de novo" initial classification was added under the Food and Drug Administration Modernization Act of 1997 to establish an additional way for novel, but less risky, devices to get to market.

No surprises in every box.  Read More & Comment...