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...

Where are the Haldol and Aspirin Lawsuits and Hearings?

12/21/2006 12:28 PM |

In the wake of sensationalist articles about Zyprexa and weight gain you would think that the next big story would be all those horrible side effects caused by typical antipsychotics like Haldol - which people like Robert Rosenheck and his cheerleaders inthe NY Times claim are just as good -- and cheaper -- than Zyprexa.

Some of Haldol's side effects.
The risk of tardive dyskinesia is around 4% per year in younger patients, higher than with most other antipsychotic drugs. In patients over the age of 45, the percentage of those afflicted can be even higher. Other predispositive factors may be female gender, prexisting affective disorder and cerebral dysfunction. See chlorpromazine for further details.
Other side effects include dry mouth, lethargy, muscle-stiffness, muscle-cramping, restlessness, tremors, and weight-gain; side effects like these are more likely to occur when the drug is given in high doses and/or during long-term treatment. Depression, severe enough to result in suicide, is quite often seen during long-term treatment.

Oh, and then there's the 'revelation' that painkillers like aspirin cause more liver injury than, say, Ketek, Senator Grassley's drug of choice.

Where are the Haldol and aspirin lawsuits? Or at least where are they in proportion to lawsuits against Lilly for weight gain associated with Zyprexa or Sanofi for 12 cases of liver injury?

Slip and fall litigation is pursued without regard to public health risk but with respect to profit.

So for those of you who commented about our earlier posts regarding the source of legal documents (and more on that later) it does matter. As long as journalists think its kosher to report the sources of income of respected academic researchers in the same sentence as they report what they say about a subject, we believe it is kosher to request that they report the source of everyone's income, particularly if that information source has a vested interest in the outcome of the case or decision that the reporter is writing about.  Read More & Comment...

Democrats are Disconnected.....

12/20/2006 02:11 PM |

A recent WSJ poll shows that 70 percent of Democrats favor having the government 'negotiate directly with drug companies' (price controls) while only half favor cutting tax breaks for oil companies.

Drugwonks is not in favor of either. But did anyone ask real questions as in "price limits like those in Europe, Australia, Canada or the VA that limit the access of new medicines to millions of patients and delays access by 3-5 years." Or what if the "cost-effectiveness criteria used to negotiate prices meant that new drugs that delay progression of Alzheimer's by five years were never developed costing our nation $10 trillion causing 2 million additional cases of the disease that might not have occured?"

Maybe a new poll is needed. One that reflects that public policy, like all of life, is a series of tradeoffs.  Read More & Comment...

GAO tell it on the Mountain

12/20/2006 07:53 AM |

Or, more to the point, the Hill.

A report released yesterday by the Government Accountability Office reports that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent and about two-thirds of the new applications were for drugs that represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.

This is yet another example of the GAO “reporting” something that is widely known, widely reported, and widely debated. But it’s worth repeating because it focuses the spotlight on the crucial need for better drug development tools – precisely the remit of the FDA’s Critical Path program.

Please refer to our report, “Prescription for Progress” which can be found at http://www.cmpi.org At that link you’ll also find video of the conference we held to discuss the future of drug development, with speakers including FDA Commissioner Andy von Eschenbach and FDA Deputy Commissioner Janet Woodcock.

But, alas, rather than using the GAO report to focus attention on the real issue, politicians are using it to pick up some cheap headlines by bashing Big Pharma.

Consider this comment by Senator Dick Durbin (D, IL), "The findings . . . raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market … Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs."

Here’s a fact that you won’t find under Durbin’s Turban – over the last 50 years the average American lifespan has increased by 10 years – a full decade, due largely to the impact of pharmaceutical research and development.

And the scary part is that 21st drug development is more complex and complicated as we move from small to large molecules and begin to aggressively research practical and personalized applications of the human genome.

But, as far as Senator Durbin is concerned, the beatings will continue until morale improves.

Step One: Give the FDA the tools it needs to help industry expedite 21st century drug development. Far too many drugs fail in Phase III. That’s not economically smart or sustainable – and it’s certainly not the best way to advance the public health. The FDA Critical Path program can help industry better understand which investigatory new drugs have the best chance for success – and which ones should be abandoned – far earlier in the process.

When asked why he was so successful, Thomas Edison replied, “Because I fail faster than everyone else.”

GAO figure.  Read More & Comment...

Legal Liabilities

12/19/2006 10:08 AM |

There's been a lot of chatter lately about transparency -- especially when it concens conflicts of interest. And transparency is a good thing.

So why doesn't this same rule apply to, say, tort lawyers and professional medical witnesses?

Yes, as a matter of fact I do have some specific examples in mind.

The first is the justice-seeking tort lawyer featured in Alex Berenson's recent articles in the New York Times. His name is James B. Gottstein, and he is identified as "a lawyer who represents the mentally ill."

That sounds very altruistic. But is he working pro bono? If not, shouldn't the story have disclosed what his potential fee will be if he wins his pending cases? Would the public's perception of the story shift if full disclosure led to a more transparent descriptor for Mr. Gottstein that read, "a lawyer who represents the mentally ill in court cases asking for $25 million in damages of which he will receive a 25% contingency fee of over $6 million?"

I am making these numbers up -- I do not know if Mr. Gottstein is, indeed, working pro bono. I do not know what damages the lawsuits are requesting, nor do I know what his contingency fee is. Guess it's not part of "all the news that's fit to print."

Next example is Dr. David Healy. Dr. Healy recently testified at the FDA hearing on antidepressants. He is a psychiatry professor at Cardiff University in Wales but also, according to the New York Times, has worked for plaintiff's lawyers in cases brought against pharmaceutical companies. That's transparency. When I served as Associate Commissioner at the FDA, Dr. Healy visited with me -- but he never mentioned that he worked for the tort bar. That's dishonesty.

Transparency isn't a sometimes thing -- and if critics of industry and the FDA want more of it, they should do more of it themselves.

"Do as I say, not as I do" is not a workable policy -- a fact that should not be ignored by the MSM.  Read More & Comment...

Alex Berenson's Zyprexa Articles: Towards full disclosure about his sources

12/18/2006 11:41 PM |

It is misleading that Alex Berenson relies upon James Gottstein as the entire source of his two articles on Eli Lilly's marketing practices with respect to Zyprexa. I am not going to even dignify his writing by discussing the scientific basis of using atypicals for illnesses other than mania.

Berenson failed to let you folks you know that Gottstein is not just a "lawyer who represents the mentally ill." What follows are a sample of some of Gottstein's quotes, activities and associates you won't find in Berenson's scribbles....

"...Representatives of mental health and consumer advocacy groups from throughout the USA will hold a peaceful protest and press conference in front of the headquarters of the Pharmaceutical Manufacturers and Researchers of America (PhRMA). Protesters allege that, "The pharmaceutical industry has taken over the mental health system. And we want it back."

MindFreedom International is sponsoring the legal protest at 12 noon on Monday, May 2, 2005 at PhRMA; 1100 Fifteenth Street, NW; Washington, DC.

"Join us and tell PhRMA to stop supporting forced psychiatric drugging! Tell PhRMA to be truthful about the clinical trials and side-effects of the medications that their member companies are profiting from," said Krista Erickson, board member of MindFreedom International.

Another protest speaker, attorney Jim Gottstein of the Law Project for Psychiatric Rights in Alaska, said, "PhRMA represents the Big Lie of Big Pharma, which should be called to account for its despicable sacrifice of people on the altar of corporate profits."

"......Jim Gottstein has been practicing law in Alaska for 25 years, including being an attorney advocate for people labeled with serious mental illness. Among many other things, he served as plaintiffs' counsel in the billion dollar litigation over Alaska's theft of the one million acre Alaska Mental Health Trust. Mr. Gottstein now devotes his time pro bono to the Law Project for Psychiatric Rights (www.PsychRights.org) , whose mission is to organize a serious, coordinated legal effort around the country against forced psychiatric drugging....."

"While the idea of screening kids for mental problems seems like a good idea, it ends up being nothing more than a Drugging Dragnet," says Jim Gottstein

Gottstein is also part of a coalition of anti-psychiatric drug groups including the Scientologists....... http://psychdiagnosis.net/Archive/endorsers.htm  Read More & Comment...

Me in the Washington Times

12/18/2006 11:32 PM |

http://washingtontimes.com/functions/print.php?StoryID=20061217-102008-3698r

Undermining drug safety
By Robert Goldberg
Published December 18, 2006

Recently the Food and Drug Administration updated its warning on the use of oral sodium phosphate products (OSPs) as a cause of kidney failure. What are OSPs? If you had a colonoscopy as I did, you drank an OSP to clear the way for your inspection. In 1998, the FDA limited the OSP bottle size to no more than 90 ml. People were going into toxic shock and dying because they were told to use a bottle of the preparation and used a 240 ml jug instead of the 45 ml or 90 ml container. The FDA just updated warning labels about exceeding recommended doses since OSP-related kidney failure is still a problem.
It seems inconceivable that you or I could find a way to take lifesaving drugs and turn them into lethal weapons. But most drugs and devices wind up causing side effects because of the human inability to follow directions. Indeed, safety problems with drug-coated heart stents boil down to this: Don't put them in patients with really blocked arteries who stop taking clot-busting medicine. The fact is, coated-stent use will be restricted, as it is with many drugs and devices, because we can't be trusted to do as we are told.
This picture of incompetence clashes with the one politicians and the Institute of Medicine peddle to the media of an FDA and drug industry rushing to approve and market medicines without regard to product safety. But a Centers for Disease Control report found that misuse and overuse of a handful of old medicines cause most dangerous side effects. Hundreds of thousands of emergency-room visits occur because of adverse drug events. The CDC notes that "Sixteen of the 18 drugs most commonly linked to adverse drug events in the study have been in clinical use for more than 20 years." The most common drug classes were insulin, painkillers containing opioids, anticlotting drugs (including aspirin), drugs containing the antibiotic amoxicillin and cold remedies.
Yet, the media and politicians pick on pills that are well known rather than risky. Ambien is a classic example. Ambien became famous (or infamous) when Rep. Patrick Kennedy claimed he crashed his car because it caused him to drive while sleeping. Thereafter, Ambien became the target of major articles in the New York Times and Washington Post for being linked to sleeping while shoplifting, midnight snacking, etc. In fact, as the folks at blogcritics.org point out: "In 2004, over 24 million prescriptions for Ambien were written. Let's say that each contained 30 pills. That's 740 million times people took this sinister drug in 2004. Timothy Morgenthaler, a Mayo Clinic researcher, reported five cases of sleepwalking in 2002. Nineteen cases were reported by one center last year. Since 1997, a whopping 207 sleepwalking incidents have been reported, most of which physicians can't link to Ambien. In fact, only 48 have been linked to this killer drug.
"It's well known that adverse incidents are under-reported, so let's assume a factor of 100... That's 4,800 incidents over, say, 8 years or 600 a year. No wonder it got banner headlines. But wait. The drug is used 740 million times a year, which means your odds of sleepwalking from using the drug are 0.00008 percent or something like 1/80,000th of a percent."
Sen. Charles Grassley wants to withdraw an antibiotic called Ketek. His evidence? The drug -- used to treat sinus infections, bronchitis and treatment-resistant pneumonia -- was approved on the basis of the nearly a decade of clinical trials, the drug's five-year safety record in Europe and a 25,000-patient study in America that unfortunately involved one doctor who faked results for about 300 patients. (The doctor was sent to prison and the results discarded.) Some claim the approval ran roughshod over time-honored FDA standards and explains why there are 23 reports of liver injury associated with 10 million Ketek prescriptions since 2003.
In fact, the FDA can approve a drug with the results of one clinical trial and prior experience with a drug. Antibiotics with amoxicillin are more likely to cause liver problems than Ketek. Acetaminophen is the most common cause of liver failure in the United States. The FDA, more concerned about drug-resistant bacteria than are fact-resistant senators, is keeping Ketek on the market.
We have defined down drug safety. What used to be our responsibility is now blamed on a FDA-industry conspiracy. We blame shoplifting and car crashes on Ambien, not on reckless behavior. Suicide, a tragic mystery, is suddenly the result of Prozac-type anti-depressants. Heart attacks are now caused by Vioxx, not by hypertension and smoking. No wonder the current FDA reform bill requires restrictions on the use of every drug that make OSP limits look like child safety locks. We want our drugs -- and our tacos -- to be 100 percent safe. They can be, if we stop making medicines available altogether. I am afraid we are already there.  Read More & Comment...

Health Care Priorities Down Under are Upside Down

12/18/2006 07:12 AM |

Last Friday (12/15) I participated on a joint CHI (California Healthcare Institute)/PRI (Pacific Research Institute) panel called "Evidence, Economics, and Politics: Australia's Experiment in Evidence-Based Medicine."

My fellow panelists included Ruth Lopert (Harkness Fellow in Health Care Policy, George Washington University, and a member of the Pharmaceutical Policy Taskforce, Commonwealth Department of Health and Aging, Canberra, Australia), Marjorie Ginsberg (Executive Director of Sacremento Health Care Decisions), Kwabena O.M. Audbofour, MD (a GP from Stockton, CA), Meryl Comer (journalist and Alzheimer's care giver), and Randy Frankel (VP, Public Affairs, IMS Health).

We used the new IMS report, "Australia’s Centralized Cost-Effectiveness Requirement for Pharmaceuticals: Potential Implications for U.S. Patients" as our point of departure.

Consider the facts and be afraid – very afraid – of the implications.

The IMS study included examination of osteoporosis and Alzheimer’s, where Australians are regularly denied access to medicines available to American patients. According to the new IMS study:

* By 2007, approximately 9.1 million patients in the United States with osteoporosis would be denied access to treatment choices if we adopted the Australian model of cost-based (aka, “evidence-based”) medicine. In Australia, for example, newer medicines for osteoporosis that are not “on the list” for reimbursement may be made available only after a patient suffers a fracture.

* IMS estimates that a 1.6 million Alzheimer’s patients could be impacted if we adopted the same system as Australia. The Aussie guidelines are identical for Aricept (donepezil), Exelon (rivastigmine), and Razadyne (galantamine) – and are highly restrictive compared with US guidelines. Australia also limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.” In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.”

Restrictive formularies that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.

The IMS report can be found at http://www.cmpi.org

CHI will be posting a series of podcasts from the event. When these are available, we will call it to your attention. In the meantime, g'day mate.  Read More & Comment...

Me in the Weekly Standard

12/18/2006 12:59 AM |

My article in the Weekly Standard on the Democrats disastrous Medicare plan entitled
Hillarycare is Back...Here's the link for anyone who cares to read it....HillaryCare Comes Back  Read More & Comment...

Ketek Kurtailed

12/18/2006 12:31 AM |

As some predicted...the joint advisory committee decided to recommend against using Ketek for sinus infections and bronchitis but leave it available for pneumonia. That's a distinction with some clinical difference but not always since at what point do you being antibiotic treatment to prevent pneumonia once you know the source of the community acquire strain of the infection? Do you simply withhold a Ketek type drug in stanching other types of infections leading up to pneumonia that are resistant to other drugs? So my guess is that there will be some retooling on the label....


As for non-inferiority trials...shame on those who call it a lower standard of approval..it is not..it is a different way of obtaining information on effectiveness and it has emerged in recognition of the existence of many new therapies that affect survival or serious morbidity, and that therefore cannot be denied patients by dumping some folks into a placebo group. So that means some people get the standard treatment and others get the new drug...isn't that what Waxman and others who are screaming about non inferiority trials with Ketek have been bitching they want more of? Or am I confused? Or are these pols so hopelessly hypocritically and twisted in knots in order to posture fot the media they don't care or is that they don't even know what an inferiority trial is or consists of? Oh, and it is not a test tube test as one ex-FDAer derided it... And let's not forget it is the basis by which many HIV and cancer drugs are approved...OK? This is what having the David Grahams of the world embedded in CDER review teams -- as the IOM in their finite wisdom has proposed -- would get us....the elimination of active controls;single well controlled trials with confirmatory evidece; creeping Grassleyism at time when personalized medicine should be bustling right along....

As Peter as noted, this is an example of the FDA just not doing a good enough job explaining what they do and how they do and the media letting blowhards like Graham distort science.... Note to Grassley...an epidemiologist does NOT conduct clinical trials or review them or know anything about infectious disease or see patients, particularl if that epidemiologist is David Graham. Rather, he just plays with his large database until he gets attention.  Read More & Comment...

Eye on .. CBS

12/16/2006 02:03 PM |

CBS Reporter Takes Swipe at Drug Industry, Praises Politician in Blog Post
Armen Keteyian lamented 'Big Pharma's' 'control' over Americans.

By Ken Shepherd
Business & Media Institute

“What can be done to break Big Pharma’s growing control of our minds and bodies? I wish I knew,” a critic of the pharmaceutical industry wrote recently on a media blog. But the author of that post was an ostensibly unbiased investigative journalist: CBS correspondent Armen Keteyian.

Network blogs can be a valuable, unfiltered look at reporters’ biases, and Keteyian’s December 14 post to CBS’s “Primary Source” was no exception.

“No matter how you slice it Wednesday was not a great day for the FDA,” Keteyian began his blog post, recounting how the December 13 “Evening News” presented “back-to-back stories” on a new FDA warning label for antidepressants and congressional criticism of FDA’s handling of Ketek, an antibiotic that can result in liver damage to some patients.

While December 13 might not have been FDA’s finest hour for public relations, the CBS reporter failed to account for how his bias could color his perceptions.

Keteyian, a former sportscaster, peppered his blog post with more anti-industry commentary, insisting that “Big Pharma seems in control [of] much of Congress, or at least its legislative agenda” before praising Iowa Republican Charles Grassley as a “straight-talking” senator who has “stood up and called out” pharmaceutical companies.

As the Business & Media Institute documented on December 14, CBS presented a decidedly sensationalistic look at the FDA’s decision to require a “black box” warning on drugs like Paxil and Zoloft when prescribed to patients up to the age of 25. In that December 13 report, Keteyian’s colleague Sharyl Attkisson focused heavily on the grief of distraught widows of suicidal patients while finding no air time for expert medical testimony.

Of course, medical experts such as NBC News’s chief medical editor Dr. Nancy Snyderman have noted that many psychiatrists find medication a crucial part of treating depression for some patients, albeit one with risks that require careful monitoring.

That dose of reality is a bitter pill to swallow for Keteyian, who lamented in his blog post that “America is a drug dependant [sic] nation” that takes pills “for just about every illness known to man or woman.”

What's the frequency ... Armen?  Read More & Comment...