Part-D Hearty

01/02/2007 08:48 AM |

Eureka! It works.

Attention Speaker Pelosi ...

ASSOCIATED PRESS

WASHINGTON – At first, Ruth Goundry wasn't sure about participating in the new Medicare drug benefit. It was too confusing, she said. But in the end, she gave it a try. She's glad she did.

As the program's first year draws to a close, Goundry estimates that she saved about $150 a month on her five medicines, compared with what she was spending before Medicare Part D began. “I would say I'm very impressed with the whole thing. I have no complaints,” said Goundry, a resident of Chesapeake Beach, Md. “It's meant a tremendous savings. I know other people who are saved by it. I mean that. They don't hardly pay anything.”

Goundry is like millions of seniors who say they are happy with the benefit, which cost the federal government about $30 billion in 2006. But the program affects seniors and the disabled differently, depending upon their income and health. There are many people who believe the program could be improved.

Just down the street, at the Chesapeake Care Pharmacy, Wesley Copeland is not so impressed. In August, he began picking up all the cost of his medicine – about $300 a month. Plus, he had to continue paying his monthly premium of $38. That gap in coverage is called the doughnut hole. “We've got a lot of people in my neighborhood who are seniors like me on retirement. We have to stretch pennies, so when it gets to that doughnut hole, we have to scramble like hell to keep going,” Copeland said.

Goundry and Copeland represent the millions of stories surrounding the addition of a drug benefit to Medicare this past year. The drug coverage has often been described as the biggest change in Medicare in the program' 40 years. Under the program, seniors and the disabled enroll in a private plan. They pay a monthly premium to the plan. The government also pays the plan.

The Bush administration estimates that the coverage saves the average beneficiary about $1,200. But many in Washington, particularly Democratic lawmakers, say the savings could be greater if the government were allowed to negotiate with drug manufacturers concerning the cost of medicine rather than leaving that chore to the plans.

Overall, about 22.5 million people enrolled in private plans during the programs first year. Nearly 7 million more people get their medicine through their employer, and those employers get a tax credit for providing that coverage. That total of nearly 30 million getting coverage through Part D is much less than was originally projected. However, analysts also didn't realize that so many seniors had insurance coverage for their medicine through other programs.

The Bush administration acknowledges the program got off to a rough start as hundreds of thousands of people showed up in pharmacy computers as not being enrolled in a plan. Beverly Dillon, a pharmacy technician in Chesapeake Beach, said that in the program's early weeks, her store advanced about 75 to 100 patients medicine to help them get by. “We would not let patients go without their medication,” she said.

The state of Maryland also stepped in to pick up the cost of medicine for poor beneficiaries, she noted. Most other states did as well. “January and February were absolutely crazy,” she said. “I would say that around March, or late February, things started to calm down.” She said many seniors are still confused about the program. To prove her point, a customer came into the store to get a refill. Dillon noted that she was in a Part D plan, but the customer was insistent that she was not and that she had coverage through another program. Dillon relented, not wanting to upset her.

Dillon said most customers who did not have insurance coverage prior to the past year are saving money. She has noticed that the checks they write to the pharmacy now are much smaller. “There's definitely a significant savings,” she said. “(But) the program just got off to such a bad start in the beginning, it just has not been smooth.”

Dillon is bracing for some rough spots in the coming weeks too. That's because some seniors are switching plans. Others have been automatically enrolled in new plans. Herb Kuhn, deputy administrator at the Centers for Medicare and Medicaid Services, said that he believes the federal government learned many lessons from the past year that will make this year's startup run more smoothly. “We have a much more sophisticated and built up infrastructure from a year ago,” Kuhn said.

Kuhn said his biggest concern going into the new year are those beneficiaries who waited until the final days of the open-enrollment period to change drug plans. He said seniors should bring to the pharmacy any kind of identification or acknowledgment letter from their plan that would show proof of membership.

Overall, Kuhn said that 2006 was a good year for beneficiaries. “We believe it's been a very positive year for Part D,” he said. “As a result of the new program, beneficiaries are living better. They're saving money.”  Read More & Comment...

Vipers of another variety

01/02/2007 07:16 AM |

In the heydays of “drugs from Canada,” there were news stories aplenty about the “Winnipeg Wunderkids,” the young pharmacists who were selling drugs to Americans and driving around in Dodge Viper sportscars. These reports rarely mentioned that they were trafficking in illegal merchandise. And there was a lot of talk of “it’s not about the money, it’s about helping people.”

That, as it turned out, was soooo 2004. Today they going out of business and, well, it’s all about the money. People are losing their jobs – but it doesn’t seem that those who got rich quick are doing anything to help those they led down the primrose path of ill-gotten gains – except maybe letting their former employees wash their fancy cars.

Here’s the story as reported in the Winnipeg Free Press.

MINNEDOSA -- The Internet pharmacy pioneers who gave birth to a half-billion-dollar industry in Canada, most of it in Manitoba, are exiting the industry. MediPlan, founded almost six years ago by four Winnipeg wunderkids ages 21 to 26, will close its doors at the end of this month here, 200 kilometres northwest of Winnipeg. About 75 people are being thrown out of work.

At its peak, MediPlan employed 170 people in Minnedosa. "There's nobody here... We're just winding down," said a woman in the human resources department on the MediPlan's second floor last week.

CanadaDrugs.com in Winnipeg has purchased MediPlan and the jobs will move to the capital city. At least 30 new employees will be needed at CanadaDrugs, a spokesman said. As the industry leader for much of its run, MediPlan, which also goes by RxNorth, had been the prime target for opponents like non-Internet pharmacies, the drug giants, and Canadian and American governments.

A person who knows MediPlan president Andrew Strempler said Strempler simply got worn down from fighting. "It was just time to get out to capture as much value as possible," the person said.

The final salvo came this summer when the United States Food and Drug Administration alleged MediPlan and another Internet pharmacy had sold counterfeit drugs into the U.S. Strempler and the Internet pharmacies association vehemently denied the claims. However, MediPlan drug shipments began being seized at the U.S. border.

"The reality is that Andrew Strempler is a man of integrity, and is committed to patient safety and patient care, and the truth of the matter is if a patient can't receive safe and affordable medication on time, then they are at risk," said CanadaDrugs spokesman Troy Harwood-Jones.

So, Strempler phoned friend Kris Thorkelson, CanadaDrugs owner. Although competitors, Strempler and Thorkelson have always maintained a friendship and mutual respect. Initially, Thorkelson agreed to take over just MediPlan's distribution practices so MediPlan drugs could reach patients. That caused the layoff of 15 people in Minnedosa in September. "As things went along, it became obvious it was a great business opportunity" for Thorkelson to purchase all of MediPlan, said Harwood-Jones.

CanadaDrugs is the largest Internet pharmacy in Canada with about 250 employees, and was 50 per cent larger than MediPlan at the time. Jobs have been offered to MediPlan employees, but Harwood-Jones didn't know if anyone had accepted. As for Strempler, he's out of the business he founded. "He's a young guy (about 32) and he's been very successful and I'm very confident he will be very successful again," Harwood-Jones said.

Strempler bought out partners Mark and Chantelle Rzepka in an amicable settlement last year. Phone messages left with Strempler's lawyer requesting an interview with Strempler weren't answered.

MediPlan was highly aggressive from start, taking out pricey full-page ads in major American dailies like the New York Times and publishing complete lists of their cheaper drugs. They also charmed many people along the way. MediPlan customers, mostly American senior citizens with chronic ailments, received their medicines in flowery pastel wrapping, with little handwritten thank-you notes attached -- more like presents at a baby shower. It was the idea of "the girls," Catherine Strempler and Chantelle Rzepka, the wives of the two pharmaceutical degree graduates.

It said much about the foursome: young, naive, energetic, idealistic, respectful, smart. Their employees were nearly all older than they were and the fresh-faced bosses were more apt to treat them like aunts and uncles.

No question, the four original partners in MediPlan walked away multimillionaires. Projections from someone inside the industry suggest MediPlan owners may have made anywhere from $10 million to $30 million. "Anyone worth their salt was making millions of dollars," during the past five years, said the Internet pharmacist, who did not wish to be named.

Mark and Chantelle Rzepka, before their marriage dissolved last year, purchased a new $2-million, 6,800-square-foot home in East St. Paul. Andrew and Catherine Strempler recently purchased Leonard Asper's $2-million, 6,500-square-foot home on Wellington Crescent. But that kind of money also presented life-in-the-fast-lane temptation. Strempler nearly killed himself when he ran his Dodge Viper sports car into a tree on the Yellowhead Highway within Neepawa town limits.

For Minnedosa and the surrounding area, MediPlan's demise is a bit like Dorothy and Toto waking up back in bed in Kansas. Six years ago, MediPlan fell into Minnedosa's lap. No one knew what it was. Almost overnight, it became the area's biggest employer and payroll. Not only were many of the jobs well-paying, but they were "clean jobs," as one person put it, meaning you didn't have dirt under your fingernails at the end of the day.

Minnedosa businesses are bracing for the fallout. Second Century Furniture and Appliance just closed its doors, but it isn't known if MediPlan is a factor. Minnedosa businesses face stiff competition from new big box stores in Brandon.

"It's almost like a gold mine strike," said Minnedosa chief administrator Ken Jenkins. "It's here, and then one day it's gone. But while it was here, it sure was nice."

MediPlan's local philanthropy will also be missed. Robert Dunston, mayor of the town of Neepawa, where the Stremplers still own a house, recalls one time when Andrew Strempler showed up unexpectedly at an annual banquet of the Neepawa Natives of the Manitoba Junior Hockey League.

The banquet always includes a fundraiser where players' sweaters are auctioned off. The auctioneer started off by asking who wanted to give him $1,000 for the first sweater. It was a joke. Sweaters might go for $300 tops.

"I do," Strempler piped up. The room went completely silent. Dunston said it was the first time he'd seen an auctioneer speechless.

However, there is some anger in Minnedosa at the federal government for not doing more to protect their biggest employer.

"The disappointment is it wasn't a business demise. It was political. For Minnedosa, that was the biggest disappointment," said John Mendrikis, who runs John's Tax Service and Accounting in Minnedosa.

Mendrikis added: "The perception out there is that large companies influence policy, and this plays into that."

No, not political. Financial. They took the money and ran.  Read More & Comment...

Deja New Year

01/01/2007 12:20 PM |

Woke up this morning early from a recurring dream. Something to do with suiting up with a new bunch of team mates and an old high school football coach. I want to show them I can still grind out the yardage. No sense of frustration, just hope and confidence.

Don't know what to feel as I see the first headlines of the new year. I careen between frustration and hope about breaking through...not in terms of getting people to agree with what we write here but at least to be more well-rounded and less beholden to the MSM echo chamber.

So here's my opening take on 2007, borne both of hope and frustration. From the Pink Sheet:


Medicaid AMPs May Include More PBM Discounts, If CMS Can Figure Out How

CMS wants to include a broader array of pharmacy benefit manager price concessions in calculating Medicaid average manufacturer prices for reimbursing outpatient prescription drugs.

Compare this lead to the Page One story in the WSJ on the health "middlemen", the final (thankfully) installment of this seris on "Health Care Gold Mines":

"Chicken producer Perdue Farms Inc. used to hire a big health insurer to bargain with doctors. Gradually, over a decade it cut out the middleman, dealing directly with doctors and hospitals just as Wal-Mart Stores Inc. often buys directly from manufacturers instead of using wholesalers. That has helped Perdue keep its health costs below the national average."

Really? How much? Does Perdue have an open or closed formulary. What else is Perdue doing? It just received an award for innovation in health care promotion and prevention. That might have something to with it to especially since drugs are only a small percentage of a health plans cost......

I am waiting for the first Democrat to use Perdue as the example for why Medicare should "negotiate" directly with drug companies. But in fact, government already does negotiate directly with drug companies through Medicaid. It just happens to do than PBMs on most drugs (atypicals seem to be the exception) but CMS can't figure out how to shift Medicaid into the marketplace. And of course no one ever counts the cost of restrictive formularies and prescription limits on Medicaid patients.

So are PBM's saving money or not? Compared to government price controls, the answer is markets move faster and generate discounts more effectively without restricting choice. There's a value to that. The WSJ articles on PBMs glance over the most important point: PBMs are simply paid to save money on drugs, not on health care costs. They are not disease managers and have no stake or ability to prevent or predict disease at an individual level. What's more important: price or value? Do we want to "squeeze" or "eliminate" firms or individuals that can provide such insight? Do we want to replace PBMs with one big government PBM that is just obsessed with drug costs? Then we are back to the Medicaid model and one size fits all drug dispensing and we move away from patient-centric medicine.

Here's another one from the Pink Sheet:

Increasing Clinical Trial Failures Highlighted In GAO Report On Drug R&D
A “systematic analysis” of why drugs fail during clinical testing could help curb the rising number of trial failures and prevent companies from repeating others’ trial mistakes, the Government Accountability Office suggests in a recent report..

Duh.

Peter and I along with a great group of people that formed our 21st Century FDA Task Force (none of whom would have been allowed on the IOM Drug Safety Task Force, include Nobel Prize Winner Josh Lederberg because of conflicts alleged by IOMatrix Sheila Burke) came to that conclusion a year ago as did the FDA with its Critical Path report. And of course a systematic analysis could help reduce the number of rare adverse events in the post market but instead we are going to drink the IOM's kool-aid and spend millions on genomically and phenotypically insensitive claims data that might spot a safety signal years later.

Your PDUFA and tax dollars at work.  Read More & Comment...

Counterfeiting Means Having To Say You're Sorry

12/31/2006 02:31 PM |

This from China...

Pfizer Inc. won a trademark case in China blocking drugmakers there from copying its Viagra impotence pills' blue diamond shape.
A Beijing court ordered the three companies to pay a $38,000 fine to Pfizer, stop producing the blue, diamond-shaped pills -- which didn't contain the active ingredient in Viagra -- and print a public apology in a Chinese legal newspaper.

(Viagra is known affectionately as "great brother" in China. Obviously lots of folks who purchased the the pill without the active ingredient wound up with "weak sister"instead. )

Now if we can only get Rahm Emanuel, Byron Dorgan, Debbie Stabenow, et al, to print a public apology in an American paper for sponsoring legislation that would encourage these companies to continue producing fake drugs.  Read More & Comment...

Slug Brains and Sluggish Brains

12/31/2006 02:04 PM |

Sea Slug Offers Clues to Human Brain Disorders....

Why am I not surprised?

According to an article at livescience.com :


The marine slug has a relatively simple nervous system, with about 10,000 large neurons that can be easily identified, compared with about 100 billion neurons in humans. Even so, the animal is capable of learning and its brain cells communicate in ways identical to human neuron-to-neuron messaging

They found specific genes linked to learning and memory. "We've now identified a whole bunch of receptors for serotonin. So we can see what their function is in various cells and which ones participate in the learning process," Kandel told LiveScience.

The scientists also analyzed 146 human genes implicated in 168 neurological disorders, including Parkinson's and Alzheimer's diseases, and genes controlling aging. They found 104 counterpart genes in Aplysia, suggesting the animal will be a valuable tool in understanding and ultimately treating neurodegenerative diseases."

Why study a sea slug...there are so many members of Congress with even less complex neuron messaging systems that are hardly being used.....but I guess they want to look at a brain that somewhat similar to humans.


And speaking of intellectual sluggishness, this will get the actively ignorant activists at Breast Cancer (In)action launched into another work of junk science....

High-Tech Mammograms Will Change Breast Cancer Care

By Meryl Hyman Harris
HealthDay Reporter
posted: 31 December 2006
11:35 am ET

(HealthDay News) -- The mammogram is changing for the better.

New computer-driven technologies should make the yearly exam more accurate and easier on patients than ever before, experts say.

High-tech computer-based digital mammography is already available at about 10 percent of diagnostic centers in the country and growing steadily at a rate of about 4 percent a month, said Priscilla F. Butler, senior director of the American College of Radiology Breast Imaging Accreditation Programs.

While filmless mammography doesn't feel any different to women while they are being screened, doctors are discovering that there are benefits for particular patients.

A study of more than 40,000 women published last fall found that compared with standard mammograms, computer-based digital "pictures" were more beneficial for more than half the women.

The findings of that study, the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial, were that younger women with dense breast tissue, those under 50 and those who are premenopausal, would benefit most from digital mammograms. The range was so large that some doctors have since concluded that dense breast tissue in all groups is better seen with the help of a computer.

Here's the full article:

http://www.livescience.com/healthday/531925.html

Anti-screening kooks have tried to scare younger women away from mammograms by peddling a hodge-podge of smaller clinical trials in the form of meta-analyses showing no benefit. Well, a meta-analysis of crappy smaller studies is just a large cesspool..which is a perfect place to store Breast Cancer Action's so-called research. The DMIST will break new ground and move us to biomarker based prediction or nano-based prediction which in turn will lead to earlier intervention with private sector developed medicines which will lead to longer lives. THAT will really overwhelm the single cell messaging systems of opponents....  Read More & Comment...

Too Many Cancer Drugs: Part II

12/30/2006 08:03 PM |

Es ist nichts schrecklicher als eine thatige Unwissenheit…That’s Goethe for “There is nothing scarier than an active ignorance.”

I wrote that in response to a post I found something called The Health Care Blog back in July (Here's the link to my post way back then www.drugwonks.com/2006/07/too_many_cancer_drugs.html ) I bring it up as an example of the thinking that provides the left with its rationalization for price controls, restrictive formularies, biased arguments in favor of single payer health system (as in people wait in Europe and Canada cause they are so rural or because they like to wait or have a cultural preference to waiting).

It's the crap -- now applied to deadly illnessess -- that we have way too many drugs that add too little benefit marketed to exploit the sick and dying. And all this dovetails with something friends and acquaintances ask me with surprising regularity:
Don't the drug companies have a cure for cancer or HIV but just don't want to make it available since it would put them out of business?

So drug companies and biotech firms actually spend billions on medicines that fail to make it to market 92 percent of the time because.. Maybe someone could .explain how this fits into the conspiracy theory?

And the genetic tests that help identify which patients will respond best to what treatments... like this most recent test that predicts patients with eye cancer...

"Identifying patients at high risk for metastasis is an important first step toward reducing the death rate of this cancer, which kills nearly half of its patients."
Ocular melanoma attacks the pigment cells in the retina. Earlier studies discovered that patients who are missing one copy of chromosome 3 in their tumor tissue are more likely to have highly aggressive cancers. Half of these patients die within five years, due to metastasis to the liver and other organs.

"When physicians know upfront which patient has a poor prognosis, they will monitor the person more closely to detect metastasis earlier and consider more aggressive treatments to increase their chance of survival, ..Knowledge of metastatic risk will also help patients and their physicians decide whether to pursue clinical trials of experimental therapies that target metastasis."

See New Genetic Test Predicts Risk Of Metastasis In Patients With Deadly Eye Cancer http://www.sciencedaily.com/releases/2006/11/061116100809.htm

Yeah but that means even more cancer drugs. Don't we have enough already?  Read More & Comment...

Sneak Preview of the Best New Health Care Idea for 2007

12/28/2006 01:15 PM |

Steve Hofman, my friend, mentor, fellow Yankee fan has come up with the best new health care idea for 2007.

In an article he has written for next week's Busineeweek (Jan 8, 2007) Steve suggests that the way to get Medicare's house in order is not -- as Democrats are demanding -- to impose price controls or restrict access to products or procedures. Rather:

"We need a way to mobilize recipients into an army ready to battle uncontrolled Medicare spending. Remember that modern armies have one thing in common: Members get paid. Every Medicare beneficiary must be paid to be part of the Medicare solution."

Pay seniors to save their own money and control Medicare spending to boot.

How would it work?

"Medicare beneficiaries would receive an annual rebate of 50 cents for each dollars they save the program. If someone saves Medicare $500, she would get $250. For saving Medicare $5000,, a beneficiary would get $2500. It's that simple."

There are right and wrong ways to cut spending. That's the point of Steve's proposal We have been doing all wrong for too long. We never gave seniors incentives to make healthy and economic choices, they same kind we all would make if we were investing our own dollars to pay our own bills.

One gee-whiz number to chew on: "If the 35 million nondisabled Medicare beneficiaries reduced their spending by a mere 5%, then $13.12 billion would be saved annually. And each 1% reduction adds $2.62 billion in further savings..."

That dough would be split 50-50 by seniors and the Treasury.

All the more reason to promote preventive and effective medicine. We haven't even begun to figure out what a combination of diet, exercise, preventive screens and right meds can do for the cost and impact on chronic illness, at least on a personal level. Steve's proposal makes it possible.  Read More & Comment...

Year in Review: Lowlights of 2006

12/27/2006 12:40 PM |

Thinking back on all the postings Peter and I...posted, it's amazing to consider just how much of a hassle the echo chamber of journalists, politicians and anti-capitalist 'experts' have become to the advance of medical progress.

When you consider the coverage of drug importation, drug safety "issues" such as Ketek or SSRIs, Part D, PDUFA or the release of big government run comparative trials like ALLHAT and CATIE as well as the release of the IOM drug safety report, we at drugwonks are reminded of what Shmuel Goldfish -- Sam Goldwyn -- the head of MGM once said about a particular bad movie his studio produced:

Go see it and see for yourself why you shouldn't go see it.

In general the coverage was objective in the sense that journalists reported what was being fed to them. Given tight deadlines and less space, reporters don't have the luxury of offering perspective or opinion...or do they?

In several instances, articles -- in our opinion -- were clearly written in a way to garner front page placement. That meant objectivity, balance, scientific rigor were sacrificed. That was the case with most coverage regarding Ketek, SSRIs and most recently Zyprexa and the cost of cancer drugs. For the most part, the best coverage on these issues -- the reporting that was comprehensive and balanced -- came from trade publications such as Biocentury, Genome Web, Drug Discovery and Development. Fellow bloggers and newsletters offered more in-depth analysis that was not tainted or spun by the usual suspects, namely Sid "Vicious" Wolfe.

Our point of view is clear: let science shape policy and guide decisions in a transparent fashion. Give patients and regulators the tools to make medicine predictive, personalized and prospective. We are tired of the either-or debate about formularies, DTC, pricing. Science and informatics is allowing us to move away from such obtuse choices. As Janet Woodcock, the Mother Courage of personalized medicine, has put it: medicine is no longer a matter of running studies to determine whether everyone should get drug A or drug B. It's a matter of developing tools to help people decide who gets drug A and who gets drug B.

Indeed, I am awaiting the results of a new genetic test to determine which statin will work best for me. No more trial and error, no more running to the doctor's office after one side effect after another. And imagine what it means for drug advertising when mass marketing of medicines doesn't matter or when one size fits all guidelines become even less relevant?

But I digress. In general the inability to place discussion of these contentious issues in context of where medical science is heading has contributed to public misunderstanding and poor policy.

Which is why I beat up on the IOM drug safety report so consistently. The report fails to look at post market surveillance as part of a complete feedback system for information that includes drug researchers and patients. It fails to integrate the scientific tools of the critical path and the emergence of personalized medicine into it;'s discussion and offers America more data dredging of little value. The IOM drug safety committe is a group of false prophets peddling 19th century solutions to 21st century challenges.
Drugwonks will provide alternatives that, unlike the IOM recommendations, will promote patient safety in real time, won't strangle drug development and discourage the best and brightest from advising the FDA.

And we will seek to provide the scientific foundation -- and personalized medicine viewpoint -- of any healthcare policy issue.

As we move ahead we will be guided by what Eric Hoffer noted about adapting in a era of turmoil and transition:

"In times of change, learners inherit the Earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists."  Read More & Comment...

Nature Articles on Obesity, Diabetes and Metabolism

12/25/2006 11:47 AM |

Excellent series of papers on the the relationship between obesity, diabetes, heart disease, inflammation, etc....the genetic and cellular mechanisms that control all and the variations thereof.

Here's the link..

http://www.nature.com/nature/supplements/insights/dia_obe_age/index.html



Oh wait, the supplement produced by Nature was sponsored by Nestle's the food conglomerate. Probably can't trust it...Must be some sort of conspiracy to make us think that gorging on hot chocolate and Nestle's Quik won't lead to weight gain...scrap it...I am sure Arnie Relman, Jerry Kassirer and everyone else who made their money selling reprints to drug companies wouldn't approve..  Read More & Comment...

Biomarkers and Mental Illness

12/24/2006 10:00 AM |

The rapidly advancing fields of proteomics and metabolomics may provide the tools necessary to develop predictive tools and tests for early and accurate screening of devastating mental illnesses such as schizophrenia and manic depression....

PLoS Med. 2006 Nov;3(11):e428.
Disease biomarkers in cerebrospinal fluid of patients with first-onset psychosis.

"....application of modern proteomics techniques, particularly mass spectrometric approaches, holds the potential to advance the understanding of the biochemical basis of psychiatric disorders and may in turn allow for the development of diagnostics and improved therapeutics."

PLoS Med. 2006 Aug;3(8):e327.
Metabolic profiling of CSF: evidence that early intervention may impact on disease progression and outcome in schizophrenia.

Short-term treatment with atypical antipsychotic medication resulted in a normalization of the CSF disease signature in half the patients well before a clinical improvement would be expected. Furthermore, our results suggest that the initiation of antipsychotic treatment during a first psychotic episode may influence treatment response and/or outcome.

No biological basis for mental illness?

"There is nothing more frightful than ignorance in action" Goethe  Read More & Comment...

The Promise of Personalized Medicine: The View from FierceBiotech

12/22/2006 01:37 PM |

I don't always agree with John Carroll's take on the issues but the FieceBiotech, Healthcare, etc websites, comments are always thought provoking, pungent, well-written, intelligent and fair. In short, some of the best health care coverage and commentary out there...Here's John's view on the GAO study


In case you haven't heard, the Government Accounting Office recently crunched the numbers and reported back that the drug discovery industry keeps spending more on research while it comes up with fewer NDAs. The trend was tracked for 11 years through 2004. I'd be willing to bet, though, that a surge in early-stage trials will eventually lead to the promised land of more marketing applications. Maybe I'm just an optimist, but the research underway in the drug discovery area is solid and it takes a number of years before the proof shows up in the NDA process. Biotech is short on magic wands and magic lamps. It's a long, slow, expensive process.

Even a nodding acquaintance with the research world, though, is enough to excite the worst kind of skeptic. The highly touted world of personalized medicine is gradually becoming a reality with solid advances in genomics, biomarkers and diagnostics. We won't get to the promised land by the end of 2007, but we'll see more steady advances as successful companies are rewarded with increased share prices.  Read More & Comment...

Greatness

12/22/2006 11:55 AM |

As chair of the Manhattan Institute's 21st Century FDA Task Force my primary function was to try to effectively convey many of the concerns Nobel Prize winner Dr. Joshua Lederberg had regarding the future of drug discovery and development. Most of the time I failed miserably. It took many drafts and much education. I was very fortunate that Dr. Lederberg was so tolerant and patient with me. Every time you met with Dr. Lederberg you received a graduate seminar in molecular biology, physics, drug development or whatever the topic of discussion happen to be.

One particular topic of Dr. Lederberg's interest now and then was the "microbiome"... In 2003 he talked about it as the next great frontier of human biology and drug discovery. He coined the term of course and has helped promote research in this area of study of the human body as “a superorganism with an extended genome that includes not only its own cells but also the fluctuating microbial genome set of bacteria and viruses that share that body space.”It has been estimated that the human body carries more microbial cells than it does human cells. Many of these microbes, however, have not been cultivated or characterized. Some of these unknown or poorly characterized microbes probably play critical roles in maintaining human health, and the interplay among pathogenic and nonpathogenic microbes, both transient and permanent members of our microflora, is likely to exert an important influence on disease. "

As Dr. Lederberg has written, “We need more research, not only on how bacteria are virulent, but how they withhold their virulence and moderate their attacks. We need to investigate how our microbiome flora – the ones that we live with all the time –don’t cause disease and instead protect us against their competitors.”

This past summer researchers completed a map of this super-genome -- our DNA and the bacteria together -- to launch a new field of genetic research called metagenomics.

As Jeffrey Gordon, one of the researchers from the Center for Genome Sciences at Washington University,who did the mapping points out, "Prospecting for these 'natural products' and characterizing the pathways through which they operate should provide new insights into the function of many of our human genes, new ways for defining our health, new ways for identifying impending or fully manifest diseases, plus new treatment strategies."

What is it that Sir Isaac Newton wrote to Robert Hooke? "If I have seen further it is by standing on ye shoulders of Giants."

We have all seen further and with greater clarity -- and hope -- thanks to Dr. Joshua Lederberg.  Read More & Comment...

What Drug and Biotech Firms Do With Their Money

12/22/2006 10:39 AM |

From the recent GAO study

“Over the past decade, new technologies including genomics and high-throughput screening have provided tools for researchers to discover and test compounds,” according to the report. “According to industry analysts, the use of these technologies has led to increasing expenses without a commensurate increase in the number of drugs developed.

“These analysts have found that although companies have invested substantial resources in acquiring technologies that have generated vast quantities of newly discover biological data, company researchers are still learning whether the data will lead to potentially valid drug candidates, resulting in compounds and drugs that have failed in either preclinical or early clinical testing.”

The report also states that in general over the past several years “it has become widely recognized throughout the [drug development] industry that the productivity of its research and development expenditures has been declining; that is, the number of new drugs being produced has generally declined while research and development expenses has been steadily increasing.”

Translation....companies are investing heavily in translational research to develop targeted therapies and move into personalized medicines in order to make medicines safer and more effective...It makes drug development more expensive in the long run while not having any effect on short term productivity or efficiency.

Consumers only care about what's new and what can help me as well they should. And they want less annoying TV ads. They want information that's useful. Setting aside the chronic conspiratorial types who believe the government is in cahoots with companies to drag kids off the streets to make them permanent zombies for profit -- and you know who you are -- both drug development and the patient-prescription- physician relationship must change to be more humane, personalized and holistic. The emphasis on genomic-based research -- away from large scale clinical trials and towards biomarkers -- is part of this positive trend.

We need regulatory and policy changes to support this revolution. The dribbings of Senator Durbin and the ravings of Congressman Stark do not bode well for the future...We at Drugwonks intend 2007 to be both a year of standing firm against this dimwitted and dimming tide and offering genunine patient-centric initiatives that embrace advances in science...  Read More & Comment...

Rahm Emanuel's Twisted Path to Price Controls

12/22/2006 10:25 AM |

Under his recycled piece of legislation, drug companies would be forced to sell as much of their old products at a government set price to foreign distributors or face criminal charges. At the same time, the FDA would be expanded to handle new duties, parcel inspection, warehouse inspection, pharmacy inspection and approving after the fact that drugs made for the European market -- though they vary in dosage form, formulation, coatings and packaging -- are equally safe and effective and bioavailable without any testing.

Meanwhile, our biotech and drug companies would still be barred and restricted and delayed from marketing products in foreign markets as they seek government -- I mean -- world market prices for the new medicines. All while the FDA is forced to spend more time handling the shipping and handling needs of European middlemen instead of drug safety and drug approval here at home.

Oh, and of course there would still be time to police the expanding array of internet drug sites that sell counterfeit meds or drain real meds from poor countries that would sold to us as well....  Read More & Comment...

The John Grishams of Drug Importation

12/22/2006 08:38 AM |

The Fearsome Foursome of Emanuel, Dorgan, Snowe, and Emerson want drug importation and are going to try to Rahm it through Congress. That’s politics. But they’re confused. They don’t seem to understand (or they choose not to admit) that you can’t cherry-pick drugs from just Canada or one or two of the 25 European Union nations. They may only want drugs from Canada, Great Britain or France, but that’s impossible — because that’s already the law – in Europe. And that's a fact.

In Europe, parallel trade (what we call “importation”) is legal between all 25 EU member states. And last year 140 million individual drug packages were parallel imported throughout the European Union — and a wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.

This means that drugs purchased from a British pharmacy to an unknowing American consumer (or a blissfully ignorant member of the United States Congress) could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by the same British pharmacies that have had a record number of counterfeit recalls in 2006. And Pharmaceutish Weekblad, a respected pharmacy journal in the Netherlands, recently reported that counterfeit medicines found in the Netherlands at the end of last year entered the legitimate supply chain through parallel importers. Stubborn facts.

In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. And all the large "legitimate" Canadian internet pharmacies already admit to getting their supplies from Europe. (An interesting and important side note is that these EU-sourced drugs aren't even legal for sale in Canada. So those folks who say we'll be getting "the same drugs as Canadians" are just plain wrong.) Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.

The World Health Organization (WHO) estimates that 8-10% of the global medicine supply chain is counterfeit — rising to 25% or higher in some countries. The largest counterfeit market with close proximity to the EU free trade zone is Russia, where the generally accepted estimate is that 12% of drugs are counterfeit. Now that the Baltic nations of Latvia, Lithuania, and Estonia have joined the European Union, WHO has warned that an increase in the risks of counterfeits entering the EU supply chain is “obvious.” Facts are stubborn things.

According to Sue Mitchell, editor of the British journal Epilepsy Today, “The parallel trade in medication is damaging people’s health and, at worse, putting lives at risk. Strong words, but when the discussion of the parallel importing of medication seems to revolve primarily around money, the reality of patient experience goes unheard all too often.”

Mr. Emanuel, Ms. Emerson, Senator Dorgan, Senator Snowe -- my 18-year old son has epilepsy. Please pay attention to the facts – and leave the fiction to John Grisham.  Read More & Comment...

From those wonderful folks who brought you drug importation: “World Pricing”

12/22/2006 07:17 AM |

Having a slow morning? Today at 10:30 a.m., U.S. Representative Rahm Emanuel (D-IL) will announce bipartisan legislation aimed at “driving down the price of prescription drugs.” The Pharmaceutical Market Access and Drug Safety Act will be cosponsored in the House of Representatives by U.S. Representative Jo Ann Emerson (R-MO) and in the United States Senate by Senators Byron Dorgan (D-ND) and Olympia Snowe (R-ME).

So, you’d expect that these fine legislators to have a solid track record against protectionism, right? Nope.

Senator Olympia Snowe (R-ME) fiercely protects against cheap imports from foreign countries when they negatively affects constituencies in her backyard. She supported the US Government’s findings that softwood lumber imports from Canada were subsidized and unfairly priced. “The implementation of the softwood lumber agreement this morning brings a successful resolution to a long and often difficult dispute,” Senator Snowe said. “This agreement levels the playing field for the softwood lumber industry and brings an end to the unfair subsidizing of the Canadian lumber industry that had threatened thousands of softwood lumber industry jobs in Maine.”

What about unfairly negotiated foreign prices for on-patent pharmaceuticals. Nope.

Senator Byron Dorgan (D-ND) is normally a staunch protectionist. Similar to Senator Snowe, Senator Dorgan staunchly defended the wheat farmers in North Dakota against subsidized imports of wheat from Canada. He went as far as to give Prairie Home Companion-worthy testimony about a family farmer at a recent Congressional hearing. He said, “The question for the "government," it seems to me that is posed by Kevin Neece and others is will someone finally stand up for family producers, for family farmers in this country and insist and demand unfair trade and insist and demand that our trading partners, in this instance Canada, comply with fair trade rules and comply with the agreements that were reached.”

What about unfairly negotiated foreign prices for on-patent pharmaceuticals that unfairly place the financial burden of R&D on the American health care consumer? Nada.

And the leader of the pack, Rahm Emanuel (D-IL), supported the Byrd Amendment. When the Deficit Reduction Act of 2005 was passed, he co-wrote a dissenting opinion that stated: “Ensuring fair trade enables U.S. manufacturers and their workers to make continued investments to preserve their global competitiveness.”

What about unfair European trade practices that threaten pharmaceutical companies with patent expropriation if they don’t accept absurdly low “reference prices” for new and innovative products? Zilch.

But who needs consistency when you’ve got sound bites?  Read More & Comment...

... but we try harder

12/22/2006 06:12 AM |

How about a little drugwonks self-congratulation.

According to Technorati (the folks who measure blog audience numbers) of the 55 million blogs out there, drugwonks.com has cracked the elite top 100,000. We're Number 92,165.

We try harder.

Thanks for being part of the ride. And stand by -- you ain't seen nothing yet.  Read More & Comment...

No Biological Basis for Mental Illness?

12/21/2006 11:37 PM |

The rapid scientific movement towards a biomarker for AD reminds me of what some in the anti-psychiatry movement -- those who would discourage and destroy efforts to screen our young for mental illness -- state when they assert " that what is called mental illness such as depression, bipolar disorder, and other anxiety problems are caused by a “chemical imbalance” in the brain -- of unknown origin – is an unproven hypothesis and little more than mere conjecture. .... There is no way that we can quantitatively measure the serotonin (or any other neurotransmitter) level in a living human’s brain. Hence there can be no benchmark correct balance.

Right..

I guess all of the following are just PR efforts by BIG PHARMA

Genetics of emotional regulation: the role of the serotonin transporter in neural function. Trends Cogn Sci. 2006 Apr;10(4):182-91. Epub 2006 Mar 10

Imaging genetics: perspectives from studies of genetically driven variation in serotonin function and corticolimbic affective processing. Biol Psychiatry. 2006 May 15;59(10):888-97. Epub 2006 Jan 25.

Functional neuroimaging of genetic variation in serotonergic neurotransmission. Genes Brain Behav. 2003 Dec;2(6):341-9.

I could go on and on....but the point is the attack on Zyprexa, SSRIs or other medicines is based on a belief, a fervent one, that medicine is not necessary, that it only the perfect capitalist instrument, a form of control that keeps the consumer permanmently compliant. I am not entering the Mothership for that discussion. By the same token, while people are entitled to their opinions but they are not entitled to bully, threaten or intimidate me or anyone else.

Though diagnosis is not perfect, marketing is often mangled and manipulative, and medicines do have risks to describe medication as "drugging" and claiming schizophrenia is not a true disorder discourages effective treatment.  Read More & Comment...

An Increasingly Randy FDA

12/21/2006 03:15 PM |

First Andy. Now Randy. And that's just dandy.

Randall Lutter Appointed Acting Deputy Commissioner for Policy

Dr. Andrew von Eschenbach, Commissioner of Food and Drugs (FDA), today announced that Randall Lutter, Ph.D., will serve as Acting Deputy Commissioner for Policy. Lutter will be replacing Dr. Scott Gottlieb who recently announced his resignation, effective late January 2007.

In this role, Lutter will provide guidance and input on all agency matters and serve as lead advisor to the Commissioner on agency policy.

“Randy has played a key role in the development and implementation of many of the agency’s highest priority initiatives,” said Dr. von Eschenbach. “The leadership he has shown in his current position as Associate Commissioner for Policy and Planning will ensure not only a smooth transition but also continued success in carrying out this agency’s mission.”

Lutter joined FDA in 2003 as Chief Economist in the Office of Planning and has most recently served as the Associate Commissioner of Policy and Planning where he coordinated the agency’s regulatory and administrative policies aimed at protecting and advancing the health of the public. In this capacity he has also served as a lead advocate for Administration, Department, and FDA policies and programs before the Congress and to the public, especially with respect to health risks associated with importation of drugs and challenges controlling counterfeit drugs.

Before joining FDA Lutter was a resident scholar with the American Enterprise Institute and fellow with the AEI-Brookings Joint Center for Regulatory Studies. From 1991 to 1997 he served at the Office of Management and Budget in the Office of Information and Regulatory Affairs and from 1997 to 1998 he was senior economist for regulation and the environment at the President’s Council of Economic Advisers.

Lutter is a graduate of Cornell University where he earned a Ph.D. and M.A. in Economics.  Read More & Comment...

Gene Genie

12/21/2006 01:36 PM |

And there are still people out there who say that "personalized medicine" and pharmacogenomics are science fiction. Well, fact trumps fiction.

New Chemical Is Said to Provide Early Sign of Alzheimer’s Disease
By REUTERS

A chemical designed by doctors in Los Angeles could give earlier signals of Alzheimer’s disease and provide a new way to test treatments, a study has shown.

Currently, the only way to diagnose the disease is to remove brain tissue or to perform an autopsy.

The new study, to be published today in the New England Journal of Medicine, is by doctors at the University of California, Los Angeles, and is part of a larger quest to find a better method to diagnose the condition using tracers that can be detected with a positron emission tomography, or PET, scan.

The new chemical, called FDDNP, attaches to abnormal clumps of proteins called amyloid plaques and nerve cell tangles that develop in Alzheimer’s sufferers and inhibit messages being processed by the brain.

In the study, Dr. Gary Small and his colleagues discovered that the chemical allowed doctors to pick out which of 83 volunteers had Alzheimer’s, which had mild memory problems and which were functioning normally for their age.

It was 98 percent accurate in determining the difference between Alzheimer’s and mild cognitive impairment, which surpassed the 87 percent success rate for a PET scan test that measured sugar metabolism in the brain, and the 62 percent accuracy rate when doctors used a magnetic resonance imaging.

The FDDNP signal can be seen in people years before they develop Alzheimer’s disease, Dr. Small said.

Finding an easier way to track brain deterioration would also make it easier to assess experimental treatments, as researchers try to prevent or reduce the accumulation of plaques and tangles.

Dr. Small and 4 of the other 15 authors named in the research paper have a financial interest in FDDNP, which has been licensed to the German conglomerate Siemens AG. He said he hoped to see it on the market in three years.

About 4.5 million people in the United States have Alzheimer’s, a number that is expected to grow as the population ages. About 15 million to 20 million more have the mild cognitive impairment that often leads to the disease.  Read More & Comment...