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According to Reuters, British drugmakers are launching a legal challenge to moves by the state-run National Health Service to switch large numbers of patients onto cheap generic prescription medicines.

The Association of the British Pharmaceutical Industry (ABPI) believes such schemes are potentially unsafe and primary care doctors are receiving additional payments to prescribe certain low-cost medicines in contravention of European law.

ABPI argues patients should have to give explicit consent for any switching rather than leaving them to object if they wish to do so.

A Department of Health spokesman said the government would rigorously defend the legal challenge.

We here at Drugwonks don't believe that doctors should be paid to prescribe anything. Their only incentive should be to do what's best for their patients. And that goes for any innovator company that would do the same thing for on-patent medicines.

But, somehow, when governments practice cost-based rather than patient-centric medicine they are called "good stewards." That's absurd -- and dangerous.

For an eloquent example of one doctor's frustration with the escalating generic switcheroo, please see CMPI senior fellow Dr. Marc Siegel's article, "The Unreal World." Here's a link:

http://cmpi.org/archives/2007/06/the_unreal_world.php

At a time when we are debating the issue of biosimilar interchangability, let's not forget to keep our eye on what's best for the patient, not what's cheapest for any given payor.
Balanced reporting or slanted coverage -- you be the judge.

Here are first three paragraphs from a story in today's Washington Post on PDUFA reauthorization:

"Three drugs -- Vioxx, Ketek and Avandia -- are casting long shadows over the congressional debate on how to update and revise the 15-year-old system that has dramatically sped up the process of bringing prescription medicines to American consumers.

All three ran into problems after the Food and Drug Administration approved them for use. The problems ranged from thousands of heart attacks partly attributable to the painkiller Vioxx to a few cases of liver failure caused by the antibiotic Ketek. And the hazards of the diabetes drug Avandia are only now emerging.

Together, the three drugs epitomize what can happen when a new pharmaceutical moves from the small and orderly world of scientific testing to the big and messy world of everyday use. Many experts now hope that efforts to do a better job of identifying the "unexpected toxicities" in drugs that have reached medicine cabinets will get a boost from an unexpected source -- the Prescription Drug User Fee Act."

Long shadows? The choice of phraseology certainly leads the reader in one direction. My favorite is when PDUFA is referred to as an "awkward acronym." As opposed to what, an elegant acronym? We all know that newspaper circulation is down, but does that explain why articles on serious subjects such as FDA reform should start sounding like dialouge from a Quentin Tarentino movie?

Here's a link to the entire article:

http://www.washingtonpost.com/wp-dyn/content/article/2007/07/04/AR20070704017.html

Let's get this guy a thesaurus and a better editor.

Danny Carlat Inc.

  • 07.04.2007
It is July 4th and am surfing the web to see what our freedoms hath wrought...

Danny Carlat, the self-styled independent shrink has a blog that lumps drugwonks into the pro pharma group and then has another grouping dubbed "Great Pharma Information."
http://www.carlatpsychiatryblogspot.com

Included are the whack jobs over at the Alliance for Human Research Protection who pushed the SSRI-suicide connection and was founded by Loren Mosher, who believed that manic depression has no biological basis. http://www.ahrp.org

Great pharma information?

And we also have the Prescription Access Litigation Project. That is a labor/Public Citizen/PIRG dragnet for lawsuits against drug companies that -- in combination with Trial Laywers, Inc. -- split the profits of settlements. No financial interest there of course. One of the law firms that is quarterbacking the PAL litigation is Hagens Berman Sobol and Shapiro which is famous for suing Apple for designing the Ipod for playing music too loud through earphones and possible causing deafness. (Volume conrtrol anyone?) Berman Sobol is also "investigating" Glaxo...as in: If you, or someone you love, took Avandia and suffered a heart attack or heart related death you may want to contact one of our attorneys in order to determine if your are entitled to compensation for your injuries. Please e-mail HBSS at info@hbsslaw.com or call 206-623-7292."

Great Pharma info indeed. Let Carlat ally himself with anti-science extremists and tort lawyers. In the wake of the SSRI-suicide debacle I will put my trust in the so-called pharma-academic complex any day..... Commercialization, carefully constructed and considered -- is the key to medical progress. The notion that purging capitalism from medical research will produce better medicine is not only a hypothesis that has been tested and rejected, it is dangerous.

Let freedom ring!

Scared To Death

  • 07.03.2007
While we are on the subject of the Fear Factory (leftist academics, medical journals and journalists) the grudging coverage of the safety of anti-depressants and their value in reducing suicide should be noted. Last week it was the NEJM deciding to publish slowly and silently a study that pregnant women could use antidepressants will little risk to their infants and a media that barely reported the results. This week it was yet another large and careful observational study -- this time by Greg Simon from Group Heath of Puget Sound -- showing that far from causing suicide, antidepressants actually reduce the risk thereof.

Setting aside the abject coverage of these important studies, the attack on the safety of SSRIs needs to be re-examined from top to bottom. We have been told that for marketing purposes companies have buried the real dangers of drugs, that direct to consumer advertising pushes people to take medicines that they do not need but are unsafe, that industry sponsored research and medical conferences are corrupting and not informative.

But now the results of following the purists are clear. We did follow the sage counsel of the Jerry Avorns, Sid Wolfes, Marcia Angells, David Healys and Jerome Kassirers of the world. We ignored the studies showing clinical benefit of SSRIs and embraced their distrustful view of medicine which was based not on science but on the belief thata because drug companies are commercial enterprises neither their products or information cannot be trusted and that any relationship they enter into corrupts those who engage in them.

We have seen the results with SSRIs. The blog PurePedantry does an excellent job of laying out the human consequences of following a medical regimen “free” of industry involvement. They cite another article in the American Journal of Psychiatry that looked at the trends in the number of kids getting SSRIs in the wake of creating an industry free zone: A more sobering perspective on these data gives cause for concern.

An article -- also in the American Journal of Psychiatry - traced what happened to prescribing of SSRIs after the fear mongering and linked it to suicide rates:

"Pharmacoepidemiological studies examining the relationship between trends in sales or prescription fills of SSRIs have consistently shown a relationship between increases in SSRI prescription rates and declines in adolescent suicide rates. On the basis of those studies, one might expect that the adolescent suicide rate would begin increasing in the wake of the FDA advisory after a decade of steady decline."




Less marketing, less detailing, less CME. More regulation and warnings. But the void is filled by self promoting quacks like Gary Null, Scientology fronts, trial lawyers, and angry critics who use anecdotal material to rant about corporate influence. And the result? Fewer patients and more death. It happened with depression and it is happening with schizophrenia and manic depression. We need more corporate involvement, not less, to advance the public health and save lives.

http://scienceblogs.com/purepedantry/2007/07/the_fda_warning_on_antidepress.php






The article today in the WSJ about a “link” between ALS and statin drugs underscores how much of epidemiology is nothing but statistical self-gratification that has grown exponentially in the hopes of seducing self-important medical journals who in turn seek to whet the appetite of journalists looking for peril in every pill.

The ALS-statin connection could have been addressed easily by asking if there was an overall increase in the incidence or prevalence in ALS since the widespread use of statin drugs beginning in the 1980s, particularly among the elderly. There are careful registry data in virtually every Western country in the world on ALS patients, some dating back to the 1920s that capture every new case of ALS and measure against increases in total populations and various demographic characteristics.

ALS incidence and prevalence is virtually unchanged since the beginning of the century. So if statins have a direct causative effect it would have shown up by now. Why no one, let alone the author of the WSJ article did not ask this simple question is beyond me.

Now more interesting is the fact that Beatrice Golomb, who is studying the evil effects of statins, claims to have found a link between low cholesterol levels and violence Indeed, there are a handful of articles that claim to have seen this association after doing some data dredging. (Uh, maybe they should control for age since most crime is committed by young people and most young people have...low cholesterol, duh.) And they NIH is giving her money?

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=11104842&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus



I can’t wait to the lawsuits flying around the claims that statins cause violent behavior. They WILL come.

Meanwhile, shame on WSJ's Jacob Goldstein and WHO's Ralph Edwards for even proposing that this is anything more than a coincidence. You give me four million data points and I will show you that there is a relationship between Jacob Goldstein and half the pregancies in Passaic, NJ.

http://blogs.wsj.com/health/2007/07/03/data-crunching-hints-at-risk-of-cholesterol-drugs/

NASTY or NICE?

  • 07.03.2007
NICE = the National Institute for Clinical Excellence -- the United Kingdom's center for deciding which medicines will be reimbursed. But more and more Britains are calling it by another, more descriptive acronym -- NASTY: Not Available So Treat Yourself.

To that end, allow us to recommend a new op-ed in the Journal of Life Sciences, "Strange Bedfellows."

Here's a taste:

"The politics of healthcare make strange bedfellows. Nearly 15 years ago, most health insurance plans opposed Hillary Clinton when she tried to give American healthcare a makeover in the image of the European and Canadian system. Back then, insurers blasted the Clinton plan as government takeover of medical decision-making based on cost considerations.

Last month, the presidential hopeful and the insurers stood shoulder-to-shoulder in support of giving the federal government the same power government agencies in single-payer systems have to determine what new medicines and services to pay for or not, based on what a government agency decides are cost-effective. In essence, both Clinton and the health care lobby want the government to engage in the practice of medicine.

What's changed? Clinton has always regarded government as the best arbiter of value for medicine. Health plans, now that they have a stake in Medicare, want the government to make across-the-board decisions about reimbursement. Now the Medicare Payment Advisory Commission, the independent federal body established to advise Congress on issues affecting Medicare, has endorsed a specific approach. It wants an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers and public and private payers.

The model, believe it or not, is Britain's National Institute for Clinical Excellence, which reviews comparative effectiveness of new and often expensive medicines in the way the Medicare Payment Advisory Commission and Senator Clinton envision. Steven Pearson, a senior fellow with the insurance industry lobbying group America's Health Insurance Plans, thinks that the British approach is an example of leadership and courage. As such, it's worth looking at the decision process our nation should follow in deciding how, whether and in what circumstances it will pay for a medicine."

Here's a link to the entire article:

http://cmpi.org/archives/2007/07/strange_bedfellows.php

And for those of you who like to read ahead, here's the article's concluding paragraph:

"Personalized medicine gives doctors and patients control over healthcare decisions while comparative effectiveness, as it is now defined, will increase government control over the choices doctors and patients make in the future. The battle over the value of medicine and who decides what is valuable will determine who controls healthcare in America over the next decade. That explains why Clinton and the insurance lobby are allies in the effort to give government more control over these important choices in the years ahead."
You cannot escape the responsibility of tomorrow by evading it today.

-- Abraham Lincoln

When the government issues health care statistics there are usually two general responses from the constituencies that are influenced – “this shows a problem,” or “the study is flawed.” And what ensues is a blame game, a political, polemical battle of op-eds and spin. What rarely happens is that all sides consider the implications of the numbers and use them to advance the public health. There are many examples of this, perhaps the best known being the debate over the Part D drug benefit.

But a new study, just released by the Center for Medicare and Medicaid Services (CMS), is breaking the mold. And it’s about time. The report, based data on Medicare patients who died from heart failure between July 2005 and June 2006, ranks hospitals as to whether they fall above or below the average and the results are available and searchable on a federal Web site (www.hospitalcompare.hhs.gov) that compares mortality rates among the nation's more than 4,000 medical facilities.

Needless to say, those scoring well crowed and those falling below the national average started the spin cycle. Examples were not hard to find – that’s not news. What is important to discuss, on the other hand, is how some hospitals dealt with their below-average ranking. As I searched through the CMS database, I was surprised to find Baylor All Saints Medical Centers at Fort Worth Texas on the “below average” side. Having followed Baylor Health Care System over the years for a variety of reasons, I decided to look a little closer.

Here's the rest of the story:

Download file

The take-away?

"... if we want people to take more responsibility for their own health – those in the business of health care must as well. Do as I say, not as I do just doesn’t cut it when it comes to advancing America’s health."

The price of greatness is responsibility.

-- Winston Churchill
Since Michael Moore regards Al Qaida as a bunch of freedom fighters this story from Britain's Daily Mail about the UK terrorists should make him and drugwonks "friends" in the blog world giddy with delight...

"Terror ringleader' is brilliant NHS doctor

An Iraqi junior doctor and a brilliant neurologist working for the NHS are among the suspects being quizzed over the series of bomb attacks across Britain, it emerged today."

And oh yes, there was a controlled explosion carried out at the Royal Alexandra Hospital.

Our prayers and thoughts are with the citizens of the UK.....

Read here
The NY Times has a editorial today supporting a government registry that would require drug companies to report all gifts it gives to doctors that might be construed as influencing their prescribing behavior. Here's the justification the Times editorial board gives for supporting this intrusion into the privacy of doctor's lives:

"As Gardiner Harris reported in The Times last week, one drug company invited doctors to a weekend training session in Orlando, Fla., to learn how to give marketing lectures to other doctors for an asthma medicine. The enticement was free airfare, a rental car and hotel room, plus a $2,700 stipend."

Enticement? How about covering travel expenses and professional time. As for the allegation that docs were "influenced". Where is the data and where is the evidence of patient harm.

Since Americans now get their information on health from major media outlets I would propose another registry: A list of all reporters who get bonuses for writing articles that "break" stories that affect people's perception of public health institutions or drug safety. It would be wrong, wrong, wrong for the New York Times or any paper to reward a reporter with a cash bonus for writing an article just because it caused a ruckus on public health matters, say for instance, an article about the financial ties of the advisory committees for the FDA. I mean a financial reward for an article on financial ties shaping decisions. I mean that would be so hypocritical as to be....ironic.

The Times should just clean it's own house or tend to it's own garden.

http://www.nytimes.com/2007/07/02/opinion/02mon2.html?_r=1&oref=slogin
Here's MedPac's upbeat message on how evidence based medicine will revolutionize health care. It will lead to

"[increased] federal administrative spending relative to current law" due to "increasing the capacity to examine the comparative effectiveness of health care services," and "[improved] decision making by patients, providers, and payers" due to "information on the comparative effectiveness of health care services."

Cut to the Subcommittee on Health of the House Committee on Ways and Means hearing on developing a new reimbursement system for Erythropoiesis-stimulating Agents (ESAs), for a reality check. In particular, the statement of Alan S. Kliger, M.D., President, Renal Physicians Association, Rockville, Maryland on "Variability in ESRD Patient Hemoglobin Levels"

"Recent studies warn that kidney failure patients should not have high blood counts, noting that a group of patients with high blood counts in general carried a higher risk than patients with lower blood counts. But my experience with one of my patients shows how patient-centered care sometimes should deviate from guideline-advised care. I have a 52-year-old patient who is in kidney failure. When his blood count is less than 36 percent, he feels tired and washed out and experiences chest pain. When EPO raises his blood count to 38 percent, he feels like a healthy man; he functions better and feels more productive. The differences are so prominent to him that he tells me what his blood count is before I have a chance to measure it. For this particular patient, a higher blood count is what he needs in order to function normally. My patient knows that the recent studies warn about the long-term side effects of these higher blood counts, but he also knows he needs these levels to function normally. His choice and mine for enough EPO to maintain higher blood counts is the right choice.

RPA believes that in the recent discourse on national coverage of EPO, the critical issue of variability of individual patient response to EPO dose has been understated. As we have noted in correspondence to CMS, attempts to assess or quantify individual sensitivities (i.e. responsiveness) to EPO at a narrow level have not been successful.

Therefore, there is no single, predictable response to a given dose of EPO, a fact that accounts for the wide range in individual responses to treatment. As a result, in the aggregate it is physiologically not rational to tailor a normal distribution of patient responses to a payment limit: such a paradigm cannot be successful in delivering optimal treatment with sophisticated agents to complicated patients.


Payment limits structured in this fashion place emphasis on the wrong arm of therapy: emphasis should be placed rather on reducing the number of patients with low hematocrits/hemoglobins (<30%/10 gm/dL). "

http://waysandmeans.house.gov/hearings.asp?formmode=detail&hearing=573

MedPAC and the rest of the comparative effectiveness club are ignoring the human consequences of one size fits all decisions such as these or the denial of cancer and Alzheimer's care in the UK, Canada, Australia. The focus is on the structure of the center, the funding, furniture, color schemes, resumes, etc.

The comparative effectiveness movement will, like the Clinton health plan, be undone, by it's arrogance, high-handedness and contempt for the doctor-patient relationship.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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