Jacob's Ladder

07/25/2007 09:06 AM |

A letter from the current issue of The Economist penned by our friend and colleague Jacob Arfwedson:

Drug tests

SIR – Your leader on the reform of pharmaceutical regulations in America maintains that safety concerns must be addressed, but why assume that the government will do a better job than independent players (“From bench to bedside”, June 30th)? In the United States private agencies ensure quality assessment (including off-label use and risks missed by the government) in a speedier way than the Food and Drug Administration.

As Peter Pitts, a former associate commissioner at the FDA, has shown, there is no direct link between additional clinical trials and safer medicines. The length of the FDA approval process has doubled since the 1960s as have the financial costs since the late 1980s. Moreover, the number of clinical trials doubled between 1977 and 1995 and the number of patients tripled. Yet in the past 40 years the share of medicines withdrawn from the market has remained constant.

Jacob Arfwedson
Centre for the New Europe
Brussels

The rest of the story is that the science of clinical trials needs updating. If we want to truly move into the era of personalized medicine, we need adaptive clinical trials that can look more precisely at sub-populations.

"Traditional" clinical trials that demonstrate a 40% efficacy rate without even attempting to isolate which 40% is expensive in financial terms and only marginally helpful in helping physicians best treat their patients. It also plays into the hands of the Evangelists of Evidence-based Medicine and the Votaries of Me-Tooism. We must think about clinical trials in new ways. It's a crucial aspect of the Critical Path.  Read More & Comment...

And speaking of Wisconsin ...

07/24/2007 11:27 AM |

From today's Wall Street Journal

Cheese Headcases

When Louis Brandeis praised the 50 states as "laboratories of democracy," he didn't claim that every policy experiment would work. So we hope the eyes of America will turn to Wisconsin, and the effort by Madison Democrats to make that "progressive" state a petri dish for government-run health care.

This exercise is especially instructive, because it reveals where the "single-payer," universal coverage folks end up. Democrats who run the Wisconsin Senate have dropped the Washington pretense of incremental health-care reform and moved directly to passing a plan to insure every resident under the age of 65 in the state. And, wow, is "free" health care expensive. The plan would cost an estimated $15.2 billion, or $3 billion more than the state currently collects in all income, sales and corporate income taxes. It represents an average of $510 a month in higher taxes for every Wisconsin worker.

Employees and businesses would pay for the plan by sharing the cost of a new 14.5% employment tax on wages. Wisconsin businesses would have to compete with out-of-state businesses and foreign rivals while shouldering a 29.8% combined federal-state payroll tax, nearly double the 15.3% payroll tax paid by non-Wisconsin firms for Social Security and Medicare combined.

This employment tax is on top of the $1 billion grab bag of other levies that Democratic Governor Jim Doyle proposed and the tax-happy Senate has also approved, including a $1.25 a pack increase in the cigarette tax, a 10% hike in the corporate tax, and new fees on cars, trucks, hospitals, real estate transactions, oil companies and dry cleaners. In all, the tax burden in the Badger state could rise to 20% of family income, which is slightly more than the average federal tax burden. "At least federal taxes pay for an Army and Navy," quips R.J. Pirlot of the Wisconsin Manufacturers and Commerce business lobby.

As if that's not enough, the health plan includes a tax escalator clause allowing an additional 1.5 percentage point payroll tax to finance higher outlays in the future. This could bring the payroll tax to 16%. One reason to expect costs to soar is that the state may become a mecca for the unemployed, uninsured and sick from all over North America. The legislation doesn't require that you have a job in Wisconsin to qualify, merely that you live in the state for at least 12 months. Cheesehead nation could expect to attract health-care free-riders while losing productive workers who leave for less-taxing climes.

Proponents use the familiar argument for national health care that this will save money (about $1.8 billion a year) through efficiency gains by eliminating the administrative costs of private insurance. And unions and some big businesses with rich union health plans are only too happy to dump these liabilities onto the government.

But those costs won't vanish; they'll merely shift to all taxpayers and businesses. Small employers that can't afford to provide insurance would see their employment costs rise by thousands of dollars per worker, while those that now provide a basic health insurance plan would have to pay $400 to $500 a year more per employee.

The plan is also openly hostile to market incentives that contain costs. Private companies are making modest progress in sweating out health-care inflation by making patients more cost-conscious through increased copayments, health savings accounts, and incentives for wellness. The Wisconsin program moves in the opposite direction: It reduces out-of-pocket copayments, bars money-saving HSA plans, and increases the number of mandated medical services covered under the plan.

So where will savings come from? Where they always do in any government plan: Rationing via price controls and, as costs rise, waiting periods and coverage restrictions. This is Michael Moore's medical dream state.

The last line of defense against this plan are the Republicans who run the Wisconsin House. So far they've been unified and they recently voted the Senate plan down. Democrats are now planning to take their ideas to the voters in legislative races next year, and that's a debate Wisconsinites should look forward to. At least Wisconsin Democrats are admitting how much it will cost Americans to pay for government-run health care. Would that Washington Democrats were as forthright.  Read More & Comment...

Harry & Louise Redux

07/24/2007 08:48 AM |

Nearly 15 years ago, when then-First Lady Hillary Clinton proposed to restructure American health care in the image of the European and Canadian systems, most health insurance providers blasted her plan.

What a difference a few years make. Just last month, Senator Clinton and the very same insurers -- in their current incarnation as a trade group called America's Health Insurance Plans -- stood shoulder-to-shoulder in support of such a scheme. Their plan would give the federal government the power to determine what new medicines and services to cover based on budgetary considerations.

So what's changed? Not Senator Clinton -- she has always regarded government as the best arbiter of health care value.

It's the health insurers who have flipped, thinking the scheme will help them save a few bucks.

The model for this marriage of old foes is Britain's National Institute for Clinical Excellence (NICE), which employs comparative effectiveness studies in evaluating whether to pay for new and often expensive medicines.

More often than not, NICE recommends against using the new treatment because it's not "cost-effective" when compared to existing treatments.

That's why many Britons refer to NICE as "NASTY" -- "Not available, so treat yourself."

As health care costs have risen, many policymakers and insurance industry elites have declared that innovative and life-changing new treatments are not worth the price. What a disaster it would be for medical innovation if a narrow-minded focus on cost took precedence over new treatments, new drugs, and personalized health care decision-making.

Here's the rest of the story as reported in the Wisconsin State Journal:

http://www.madison.com/wsj/home/column/other/index/php?ntid=202448&ntpid=4

On Wisconsin!  Read More & Comment...

Not Lost in Translation

07/23/2007 08:49 PM |

What's on the minds of Turkish journalists covering health care ... counterfeit medicines.

Here's an article that ran in one of that country's largest national daily newspapers, "Dunya"

http://cmpi.org/images/headlines/dunya_1407_pp.jpg

And, for those of you non-Turkish speakers, here's the translation ...

Counterfeit drugs are a major problem for our country, too

One of the most important factors that play a role in the prevention and treatment of diseases is undoubtedly drugs. When successfully treated, conditions such as hypertension are prevented from leading to strokes or heart attacks and drugs that provide effective treatment for diseases such as cancer, AIDS and Alzheimer’s also play a vital role.

Seen from this perspective, an expeditious introduction of new and effective (innovative) drugs for patients’ use does not increase healthcare costs; on the contrary, it is one of the most important factors that reduce healthcare costs. Countries that do not single out cost as a top criterion and take into consideration the overall benefit that a certain drug provides have a healthier social structure and are also able to control their total healthcare costs more easily. There is a large number of scientific studies that confirm the validity of this approach.

In our country, the cost of treatment is almost always viewed as identical to the cost of the associated drug. The rationale behind this approach is that “drugs” represent the measurable and avoidable aspect of basic healthcare costs. The government presents an approach whereby it directly prevents innovative drugs, which are relatively expensive due to their R&D costs, from being put at the service of society.

As a consequence, the number of saved lives decreases and, due to other healthcare expenditures, total healthcare costs inevitably increase. This governmental approach targets all pharmaceutical companies, local and foreign.

Delays in registration play a role in the rise of counterfeit drugs

The fact that innovative drugs have a higher price tag and are not reimbursed by the government has another important repercussion – the rise in counterfeit drugs. Two recent examples in our country presented a clear proof of this phenomenon. Counterfeit versions of two drugs, one for erectile dysfunction, the other for cancer treatment, were clandestinely released into the market. In his recent visit to Turkey, the former Associate Commissioner for External Relations at the American Food and Drug Administration (FDA), Mr. Pitts related his experience on counterfeit drugs. At a press meeting he organized at the Head Office of the Association of Research-Based Pharmaceutical Companies (AIFD), Pitts stated that the expeditious presentation of newly developed and safe drugs at the service of patients has become a priority throughout the whole world and emphasized that, thanks to this approach, patients have increased chances of surviving diseases such as cancer, MS and Alzheimer’s. Pitts pointed out that Turkey’s predominantly young population is a major advantage and that an expeditious introduction of effective drugs at the service of patients without much delay would allow chronic diseases to be treated in a timely manner which would potentially reduce heavier treatment costs down the line.

Buy your drugs only at pharmacies

However, the single most important issue that Pitts emphasized involved counterfeit drugs from China, Russia and South American countries and the damage they cause on human health. Pitts said that as counterfeit drugs provide significant profits, it has become increasingly difficult to fight them and that, in order to avoid counterfeit drugs, individuals must first be wary of environments where counterfeit drugs may be sold and they should not be swayed by the relatively inexpensive prices of these drugs.

Accordingly, it is very important to closely monitor each stage of the distribution channels, to place a barcode and identification on each drug package and to systematically implement as well as increase penal sanctions. Therefore, our most vital suggestions to protect ourselves from counterfeit drugs is to “purchase drugs from pharmacies and refuse to purchase drugs without barcodes”.

Nearly all cases of counterfeit drugs in our country up until now have resulted from drugs outside the official distribution channels. The proper approach that will fundamentally resolve the problem is to shorten the registration process for innovative drugs and expeditiously present them at the service of our citizens.

Ankara's Away!  Read More & Comment...

Nissen Says von Eschenbach "Whines" About Drug Approval Being Too Slow

07/23/2007 03:59 PM |

It is obvious Nissen tailors his remarks to the audience....so here he is talking trash about Andy von Eschenbach and Scott Gottlieb to an NPR crowd a while back...

Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, was recently a member of a panel debating the topic of: "Government Science Panels: Fair and Balanced?" which was moderated by National Public Radio's Snigdha Prakash, and sponsored the Center for Science in the Public Interest on Aug. 2 2006.

Dr Nissen spoke about the conflict-of-interest problems "evident at the highest levels of the FDA," the article says.

"For years," Dr Nissen said in describing FDA leadership, "we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies."

"Then the administration appointed Andrew Von Eschenbach as interim commissioner, creating another conflict," he noted.

"In his role as director of the National Cancer Institute," Dr Nissen said, "Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict."

But even worse, he said, "the administration appointed Scott Gottlieb as deputy commissioner."

"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter
"Between them, Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development."

"So while the American people worry about the safety of drug the top FDA leadership tells us we need faster drug approval."

Funny, I thought people cared about both. And for such a smart guy who wants to be FDA commish, the inability to conceive of faster drug approval and safer medicines being one in the same reflects scientific stupidity or political cupidity, or both. And for someone whose own studies have demonstrated excess mortality in the wake of promoting the stocks of companies he conducts research for, I would not be talking about putting profits before safety if I were him.  Read More & Comment...

Nissen's Nonsense

07/23/2007 02:19 PM |

I have decided to pull together the best of the blog commentary on Nissen's Avandia study:

From the Angry Pharmacist

http://www.theangrypharmacist.com/archives/2007/05/avandia_oh_why.html

From Respectful Insolence..

http://scienceblogs.com/insolence/2007/05/well_well_well_what_have_we_here_about_t_1.php

Kevin MD (who cites Medpage who cites but does not attribute my comparison of the WHI to Avandia risk)

http://www.kevinmd.com/blog/2007/05/avandia-and-heart-attacks.html

Dr. Kevin links to Nissen -- one day after making his Avandia > 9-11 tragedy with this ask and answer with Newsweek:

"Is there a case for prescribing Avandia? Are there some patients for whom the benefits outweigh the risks?

Again, I don’t think I want to go there. It’s important for me as a physician-scientist to put the data out there in a very neutral fashion, and not cast judgment about what people ought to do. We’re going to let everybody read our paper and make up their own minds. Obviously the FDA read our paper because they just issued a safety alert."

What a creep.

http://www.msnbc.msn.com/id/18789572/site/newsweek/  Read More & Comment...

NYT Swallows St. Steven's Sob Story

07/23/2007 10:46 AM |

Yes, Steve Nissen has sleepless nights about drug safety, particularly about the misuse of surrogate endpoints to approve drugs (which is why he has developed IVUS to develop a surrogate endpoint for drug approval).

And he compares Avandia's risk of death to that of 9-11 (though even his own meta-analysis did not estimate increased number of deaths only risk of having a heart attack sooner and not death).

He tells Diedtra Henderson of the Boston Globe he doesn't want to be FDA commissioner but tells the NYT he won't rule it out.

He uses the "I give all my money to charity" line but there is nothing about the fact the charities are his own research organizations and the Steven E Nissen Healthy Heart fund that doled out gym memberships and travel money to people at the ACC.

He is described as an "informal advisor to Congress" on drug safety. How about someone who coordinated with Congress to preempt the FDA's own analysis of Avandia in order stoke support for alternative FDA reform proposals. Who was working with Congressman Waxman and the NEJM to release his paper, supposedly told a Glaxo rep he was going to "destroy Avandia" but had the chutzpah to claim to the media he offered Glaxo the chance to co-author a paper.

Nissen's behavior with respect to Avandia and the increasing criticism that has been leveled at his "study" (if all the short term data showed a 40 percent increased risk, why is there no hint of it in long term studies like RECORD) were all neglected in the NYT study.

I predict that when all is said and done Nissen will be revealed as the Michael Nifong of medical research.

http://www.nytimes.com/2007/07/22/business/22nissen.html  Read More & Comment...

Talking Turkey

07/23/2007 08:21 AM |

Last week I had the opportunity to speak to a roundtable of Turkish journalists on how the second largest nation in Europe can help to reinvent and reinvigorate its health care system.

We talked about why getting new drugs to market in a timely manner is in the best interest of the public health. We talked about how government-run health care systemts often make the mistake of focusing on cost-based rather than patient-centric care. We talked about the dangers of counterfeiting. We talked about the need to develop better "evidence" for the era of personalized medicine. We talked about the urgent need to design a health care system that stresses prevention and chronic care.

In short, it sounded very much like the health care debate in Europe and the United States.

Except there's one enormous difference -- Turkey, demographically speaking, is a young nation. And that's a terrific opportunity. Rather than focusing on the health care needs of a fast-aging population (as is the case in the US and the EU), Turkey has the chance to "start young and stay healthy" -- avoiding many of the "chronic" problems we now face (diabetes, hypertension, high cholesterol, obesity, etc.)

Turkey has the chance to avoid these health care anchors and show us all how to do it right.  Read More & Comment...

Mirror, mirror on the wall who's the most conflicted of them all?

07/20/2007 09:58 AM |

Take a look at who is board leader in conflict cash for the upcoming Avandia Adcomm.
Steve Nissen is pocketing nearly $1 million in study money from companies that are directly competing AGAINST Avandia. The rest of the folks have stock and speaking fees less than $10K per. In fact, St. Steven the Pure has racked up more conflict cash than the rest of the exemption seeking members combined..

And the media? Why, nary a word on the conflict back when or now even as Steve spins them feverishly in the lead up to Adcomm.

http://www.fda.gov/ohrms/dockets/ac/07/waivers/2007-4308w1-00-index.htm  Read More & Comment...

A Gathering Against Cancer and For Life

07/18/2007 11:49 AM |

CMPI held an event yesterday (as noted in my previous post) on Capitol Hill where it released a report entitled “The Effect of Chemotherapy
Innovation on Cancer Survival, 1991-2003: State Level Evidence from the SEERMedicare
Linked Database.” The report written by Dr. Frank R. Lichtenberg of Columbia University and the National Bureau of Economic Research in conjunction with the Center for Medicine in the Public Interest proves that using new cancer therapies is an effective way of lengthening the lives of cancer patients.

But it was more than your usual DC get out the report event. It was time to both celebrate what medical progress can provide and reassert the dying proposition that public policy should focus on what value medicines can add to people lives instead of what money can be squeezed from the lives of patients.

Michael Katz, VP of the International Myeloma Foundation http://www.myeloma.org/ spoke of not being a statistic because as a 17 year survivor of multiple myeloma, he should have been dead and not seen his three children grow and graduate college.

Congressman Mike Ferguson spoke of the joy he felt in hearing Michael's story and of the fact that his mom, who also had multiple myeloma, lived long enough to see her grandchildren. He spoke of the pride and joy he felt knowing that Celgene, the company that has developed a pill replacing blood transfusions for MM, is in his district.

Press events are usually canned activities but because of the people and passion that everyone brought, it was much more. I didn't know when we invited Mike that our event fell on the fourth anniversary of his mom's death. But it only reinforced our sense that CMPI's mission is, in Mike's words, to promote medical progress that saves and extends lives.

Thanks to everyone who made this possible.  Read More & Comment...

Alex Hits a Homerun

07/17/2007 07:35 AM |

Berenson, not Rodriguez... With his latest piece describing how reimbursement factors create variations in oncology practice that appear delay access to new and in some individual cases, better, cancer drugs. (He calls them market forces, but why quibble.)

This should be a cautionary tale to those in the comparative effectiveness cult: a reimbursement code is as good as a death sentence to thousands of cancer patients if it creates practice variations that delay access to drugs that work for particular groups of patients.

For even more evidence of that, CMPI released study yesterday by Professor Frank Lichtenberg of Columbia University showing a direct association between access to new cancer drugs and increases in life expectancy and survival from cancer between the years 1991-2003. And for those who bleat that we need comparative effectiveness to turn each patient into a cost center consider that Dr. L found that each additional year of cancer free life cost $4300, a fraction of what other economists pegged the value of that achievement: $250k.

You can find the Lichtenberg study later at http://www.cmpi.org

The Berenson piece is here: http://www.nytimes.com/2007/07/14/health/14lymphoma.html?_r=1&oref=slogin  Read More & Comment...

Media Mangles AHQR Report, But So Do It's Authors

07/16/2007 10:17 PM |

"Older, cheaper diabetes drugs are as safe and effective as newer ones, concludes an analysis that is good news for diabetics and may further hurt sales of Avandia, a blockbuster pill recently tied to heart problems.

The clear winner: metformin, sold as Glucophage and generically for about $100 a year. It works as well as other diabetes pills but does not cause weight gain or too-low blood sugar, the analysis found. It also lowers LDL or bad cholesterol."

http://news.yahoo.com/s/ap/20070716/ap_on_he_me/diabetes_drugs;_ylt=AjRpOmAY4PhCXhkEvojSg37VJRIF

I guess AP was just reading the press release and not the report or even the exec summary which carried these important tidbits:

The study only focused on monotherapy while the trend in diabetes care is towards combination therapy to maintain glycemic control, blood pressure, cholesterol. Hence, Avandia or Actos will be used in combination with Glucphage or insulin, not one or the other.

The study ignored many important clinical endpoints for which combination therapies are used, hyperinsulinaemia, for instance or fat build up.

The study acknowledges that combo therapy works better than monotherapy.

It also acknowledges that the supposed superiority of weight loss associated with metformin could be due to removing a prior drug used in head to head comparision trials so that the weight loss is an artifact of an experiment not the medicine. Oh.

So why did the authors not make these caveats in their statements to the media and so eager to push metformin as the....cheapest and best? Here is what the authors siad in their article in the Annals of Internal Medicine: Drugs like metformin "lower cost, longer use in practice and more intensive scrutiny in long-term trials" But the trend is towards combination therapy. Do I detect a bias, a falling into line with a ideological bent beyond what the data suggest? Is this ALLHAT and CATIE redux?

http://www.annals.org/cgi/content/full/0000605-200709180-00178v1  Read More & Comment...

Arnold Relman: Off His Rocker

07/16/2007 05:34 PM |

To see what happens when too many people toady up to for too long and what being imperious does to one's brain cells and personality, read Arnold Relman's screed against Richard Epstein's book "Overdose: How Excessive Government Regulation Stifles Pharmaceuetical Innovation."

To be fair, Epstein lays into Relman in his book, so Arnie is entitled to hit back. But the review is long, boring and short on detail. He never rebuts Epstein's claim. Rather he just screams that Big Pharma buys and sells the FDA and every other major political institution. Well if that's the case, why do so many of their drugs fail to make past FDA reviewers? If the marketing is so successful why not crank out one me too after another and just ram them down the throats of stupid docs and consumers? Why invest in innovation at all? Then the problem of government regulation disappears.

Relman is so obsessed with his droning that he does not realize he has no point. That is the biomarker of a zealot or some other condition.

http://www.tnr.com/doc.mhtml?i=20070723&s=relman072307  Read More & Comment...

Agency for Health Qualty and Research on Avandia: It's A Wonderful Drug

07/16/2007 05:10 PM |

Avandia raises good cholesterol and (however it raises bad )while controlling diabetes..how about that? To quote the study... "Pioglitazone and rosiglitazone cause a small but significant increase in high-density lipoprotein, often called "good cholesterol" because it promotes the breakdown and removal of cholesterol from the body." This has been Nissen's holy grail...it must kill him to see it reported in a drug he tried to destroy while others he has worked on have tanked...

And the study which looks at all forms a drugs to control Type 2 diabetes, many of which are used in tandem, is a kick in a teeth to Nissen's sloppy and skewed handling of the data and Furberg's hysterical handling of the results thereof. Now that they two have been added to Adcomm, let's see if they behave responsibly before, during and after the meeting instead of trying to inflame passion. My guess is, on the heels of the AHQR study and a recent microvascular study by Eric Topol and colleagues showing a protective effect impact from Avandia in certain patients with metabolic disorders undergoing revascularization, the black box warning will be mild and some primary care docs might even begin to prescribe again, though not to patients at risk for CHF.

Now let's see how the media covers this study and its rebuke to Nissen.

http://www.ahcpr.gov/news/press/pr2007/effdiabpr.htm

Seel also "Peroxisome proliferator-activated receptor gamma agonists for the Prevention of Adverse events following percutaneous coronary Revascularization--results of the PPAR study."

Am Heart J. 2007 Jul;154(1):137-43.  Read More & Comment...

See, It WAS Big Pharma All Along....

07/13/2007 10:08 AM |

When is a serious side effect not a serious side effect?
When the people who are at risk or talk about it receive support from drug companies.
At least that's what the WSJ implies in it's article about people with epilepsy who suffer seizures when they are switched -- without their consent -- to a generic version of an anti-convulsant to save a few bucks.

PILL PUSH
Industry Fights Switch
To Generics for Epilepsy
Big Drug Makers Help
Patient Groups Lobby;
More Attention to States
By SARAH RUBENSTEIN

In state legislatures across the country, the Epilepsy Foundation has been campaigning for bills that would make it harder for pharmacists to switch patients to inexpensive generic epilepsy pills. The effort is getting behind-the-scenes support from drug companies -- a sign of how the industry, long a potent lobbying force in Washington, is increasingly looking to states to achieve its goals.

http://online.wsj.com/article/SB118426152232264867-search.html?KEYWORDS=epilepsy&COLLECTION=wsjie/6month

I will get to the science behind this issue -- and there is science, though you wouldn't know it from reading the piece -- in a second. But consider this:

The WSJ piece depicts the epilepsy drug switch-side effect issue as anecdot dotted campaign led by Big Pharma to keep their drugs on formulary. Yet Steve Nissen receives money from drug companies and did a slap dash study about heart attack risk of Avandia and that was front page news. He had to pool studies of widely varying quality and size (basically pooling anecdotal information) and he was hailed by the media as a whistleblower.

Now AP reports that the FDA is getting anecdotal reports of heart attacks from Avandia users (no surprise since diabetics are 2x likely to have heart problems than others) and claims that this is evidence of Avandia's dangers previously being under-reported. "Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet."


http://news.yahoo.com/s/ap/20070713/ap_on_he_me/diabetes_drug_risks_8

Now to the evidence of drug switching triggering seizures. Anti-convulsants have very narrow therapeutic windows. So switching, whether from one brand to another or from a brand to a cheaper older med can cause problems. That is fact.

Here is one study "Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes." Epilepsia. 2007 Mar;48(3):464-9. The study found: These results reflect poor acceptance of switching AEDs (anti-epileptic drugs) to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use."

So what did we learn class?

Take adverse reports after hysterical reporting of a sloppy and politically motivated meta analysis on Avandia seriously. Why? Not generated by Big Pharma.

Ignore the reports of seizures associated with compulsory drug switching to generic anti convulsants. Why? Obviously generated by Big Pharma.

And what about the scientific basis behind the seizures? Too bad. If someone is supported by Big Pharma, then they obviously deserve to get seizures anyway.  Read More & Comment...

Sicko Sinks At the Box Office

07/12/2007 04:22 PM |

Sicko open last week in 300 theaters and took in $4.5 mill. This past week it took in $3.6 in over 700 theaters.

More people saw Moore get the crap kicked out of him by Sanjay Gupta on Larry King Live than went to see his movie.  Read More & Comment...

Want To Live Longer? Take New Drugs

07/12/2007 08:27 AM |

In another blow to those who want keep Americans taking old medicines by banning access to free samples, marketing, continuing medical education, off label use and other methods that increase new drug use, this from my former perch at the Manhattan Institute and Frank Lichtenberg:

"It is no surprise that Americans are living longer today than in previous generations. A typical baby born in 1900 was expected to live to about age 45. Today, life expectancy at birth is about 78. Less well known, however, is the fact that the gains in life expectancy have not been uniform across the country. In his new study—the first of its kind—Columbia University researcher Frank Lichtenberg set out to find out which states are the leaders, which ones are the laggards, and why.

Lichtenberg then set out to examine why this “longevity increase gap” exists by measuring the impact of several factors that researchers agree could affect life expectancy. He found that, although some obvious suspects—obesity, smoking, and the incidence of HIV/AIDS—played a role, the most important factor was “medical innovation.”

Specifically, Lichtenberg found that longevity increased the most in those states where access to newer drugs—measured by mean “vintage” (FDA approval year)—in Medicaid and Medicare programs has increased the most. In fact, about two-thirds of the potential increase in longevity—the longevity increase that would have occurred if obesity, income, and other factors had not changed—is attributable to the use of newer drugs. "

Here's a link to the study:http://www.manhattan-institute.org/html/mpr_04.htm  Read More & Comment...

CNN's Dr. Gupta Gives Michael Moore an Evidence-Based Enema

07/11/2007 07:52 PM |

By the looks of it and the typical Moore reaction (attacking his critics personally) CNN's Sanjay Gupta's look at the fudgy facts of Moore's movie have really hit a nerve. Moore was really steaming as Gupta continued to point out that links to MSNBC web sites are not real citations and projected numbers are not actual dollars spent.

Even when Moore's acolytes and staffers try to defend him they step in it. For example, Deborah Burger, the head of the California Nurses Association claims that Aetna CEO Troy Brennan claimed that " recent statistics from the Institution of Healthcare Improvement document "that people are waiting an average of about 70 days to see a provider."

http://www.michaelmoore.com/sicko/news/article.php?id=10023

Uh, actually the Institution FOR Healthcare Improvement document was referring to the Amarillo VA Health Care System which reorganized Primary Care in January 2000 based on the principles of Advanced Clinic Access. It had a waiting time for 76 days and reduced the time to 20 days by using the new software system. And the system is designed to reduce the backlog of no-show appointments which is unrelated to excess demand.

It took them one month to cut the waiting time by two thirds. Meanwhile, primary care waiting time for first appointments in the UK are, what, 3 months at a minimum?

And don't give me the crap from the Commonwealth Fund...that compared Medicaid recipients (government care) and the unisured poor to middle class and rich people who supplement their care with private health insurance in other countries. And Commonwealth failed to sample in rural areas internationally where health and access disparities show up. And even then, Americans did as well or better than less diverse and urbanized countries in getting prompt care. Oh, they never told you that? Neither does Michael Moore.

Read here
  Read More & Comment...

The Lead Law Firm of the Prescription Action Litigation Project Goes To the Slammer

07/11/2007 08:26 AM |

The Priesthood of Pharmaceutical Purists use trial attorney winnings to in part finance their attack on industry. One of their meal tickets is going to three squares behind bars.....

"Milberg Weiss' Bershad Pleads Guilty to Conspiracy in Kickback Plan
Name partner at securities plaintiffs law firm agrees to cooperate and to forfeit $7.75 million"

David J. Bershad, a name partner at securities plaintiffs law firm Milberg Weiss & Bershad, has pleaded guilty to federal charges that he conspired in the payment of illegal kickbacks to individual class action plaintiffs.

The guilty plea by Bershad, entered Monday afternoon in federal court in Los Angeles, raises the stakes for his co-defendants, former fellow name partner Steven G. Schulman and the Milberg Weiss firm itself, as well as the other major Milberg Weiss figures, Melvyn I. Weiss and William S. Lerach, who have so far escaped indictment.

http://www.law.com/jsp/article.jsp?id=1183971987057&rss=newswire

Now Millberg Weiss is part of the Prescription Access Litigation Project (PAL). But PAL conveniently leaves the firm off it's website. But since drugwonks is all about transparency, here is a reminder of their close connection, courtesy of MassPIRG

http://masspirg.org/MA.asp?id2=5318&id3=MA& and PAL itself

http://www.prescriptionaccess.org/press/pressreleases?id=0013  Read More & Comment...

Steve Nissen and the Media Inconsistent Together

07/11/2007 08:19 AM |

Trevor Butterworth sums up the sad state of Steve Nissen, the NEJM and the media in his post. And the Priesthood of Pharmaceutical Purists, trial attorneys and assorted Whack Packers want to entrust the public health to these sort of people???

http://www.huffingtonpost.com/trevor-butterworth/a-crusading-doctor-stumbl_b_55681.html  Read More & Comment...