If iPhones Were Pharmaceuticals

07/06/2007 08:00 AM |

From the American Spectator:

If iPhones Were Pharmaceuticals

Prescription drugs cost too much! Or at least that's what we hear, day-in and day-out, on television, in the news, and, of course, in Sicko.

Some health-care activists have rallied around high drug costs to agitate for more government regulation of the pharmaceutical industry and more government involvement in health care. Hoping to stoke public anxiety over prescription bills, these activists often point to "cheaper" foreign drug prices to garner support.

Fortunately, prescription drug price controls aren't coming to the United States. But now activists have turned to a new tactic: proposing to force American drug companies to sell their wares to foreign governments at whatever price and in whatever amounts those governments demand. American companies would also be unable to contractually bar those drugs from being imported back to the U.S. -- leading, in essence, to the imposition of foreign price controls and all their attendant safety complications.

Needless to say, this idea -- that the government should require an American industry to play cowering "yes-man" before the whims of foreign nations -- would be devastating to any of America's top industries. Imagine if a different sector of the economy -- say, a high-tech firm like Apple -- had to cope with such constraints.

Apple might schedule a meeting with a foreign distributor, but instead of haggling over bulk discounts and special deals on excess pink iPods, its representatives would find the terms of the sale already structured. The foreign buyer would be able to name its price and quantity, and it would demand permission to resell everything it purchases back to U.S. consumers.

In the background, the U.S. government would nod approvingly.

In other words, what used to be a process of negotiation would instead be a process of submission. Apple would have no way to protect its product or its revenues. It would certainly end up in deals that it would otherwise never agree to. And investment into the next generation of iPods, iPhones, and other products would decline.

Apple's domestic operations would suffer, too. Having just gotten a steal of a deal from Apple, the foreign distributors would be able to undersell domestic firms in the U.S. by reselling Apple products at a significant mark-up. Who benefits? The middlemen, of course. Consumers would only see a tiny price break and Apple and its domestic distributors would see a nosedive in sales. This isn't an example of market forces at work; it's the unfair exploitation of domestic firms.

Initially, Apple might find a way to adjust to forced sale. But in losing control over the terms of sale and distribution of its products, it's almost a certainty that the company's bottom line would take a massive hit.

In response to the loss in revenue, budgets would be slashed, with research and development into new products an early casualty. And with the threat of price controls destroying the prospect of new financial success, the next product would take longer to get to market and be far less innovative. Developing the next big computing device is a costly, time-intensive, and risky undertaking, so the stakes for a successful new product would be much higher.

With no margin for error, following up the iPod with the commercial equivalent of Betamax could be fatal. And that death would stand out as a blow not only to the American computing industry, but to broader American economic competitiveness as well.

Apple and the rest of the American high-tech industry may not have to worry about foreign governments dictating the prices they may charge while the U.S. government looks on approvingly. But advocates of forced sale are pushing for precisely this kind of absurd policy on pharmaceutical companies. The class of good may be different, but the effect is the same -- financial disaster and reduced innovation.

In fact, because drugs save our lives rather than simply entertain us, such stifling of the next round of research may be fatal not only to pharmaceutical companies, but to us as well.

Instituting a forced sale policy on any other industry would result in a great deal of outrage. It's high time that we treat such dressed up price controls on pharmaceuticals with similar looks of consternation.

Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former Associate Commissioner of the FDA.   Read More & Comment...

Patients first please, we're British

07/05/2007 09:17 AM |

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.  Read More & Comment...

PDUFA. Pulp Fiction?

07/05/2007 08:38 AM |

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.  Read More & Comment...

Danny Carlat Inc.

07/04/2007 12:20 PM |

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!  Read More & Comment...

Scared To Death

07/03/2007 03:23 PM |

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






  Read More & Comment...

Statins Cause ALS? Fat Chance

07/03/2007 02:55 PM |

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/  Read More & Comment...

NASTY or NICE?

07/03/2007 08:42 AM |

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."  Read More & Comment...

When the All Saints Come Marching In

07/03/2007 08:08 AM |

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  Read More & Comment...

Here's a NHS Doc Sicko Missed

07/02/2007 06:00 PM |

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
  Read More & Comment...

Is Your Reporter Tied To Bonuses?

07/02/2007 09:42 AM |

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  Read More & Comment...

Early Reality Check on Comparative Effectiveness

07/02/2007 09:12 AM |

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.  Read More & Comment...

"Most Americans believe that ..."

07/02/2007 07:46 AM |

Does that headline look familiar? Of course, you see it all the time in headlines about "new poll findings." But, as any savvy drugwonk knows, you can get any answer you want depending on how you ask the question.

So we decided to see what some New Yorkers know -- or think they know -- about a couple of health care issues in our latest podcast.

Have a look:

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

If you have questions that you'd like us to ask in our next podcast, please send them along by commenting via this blog.  Read More & Comment...

Patent Farm: Chilling Innovation in the Great White North

06/29/2007 01:02 PM |

“All animals are equal, but some animals are more equal than others.” A famous line from a famous book with a famous lesson – they’re not.

Today that lesson needs to be relearned. Case-in-point, a Canadian judge’s apparent belief that all patents are equal, but some patents are less equal than others.

Specifically, pharmaceutical patents.

But first a point of order – this is not about the position of the Government of Canada, which is very good on these issues. This is about the actions of an activist judge – the Honourable Mr. Justice Hughes, of the Federal Court of Canada.

It’s about a patent case brought by Novopharm (the large Canadian generics company) against Eli Lilly (the large American pharmaceutical company). But the issue is considerably broader and the precedent is frightening not only for innovator pharmaceutical firms – but for the future of Canadian public health.

The issue, relative to a pharmaceutical patent, “… is the sufficiency of the disclosure in the patent itself…” Judge Hughes’ decision has created a requirement that “… the advantage must be plainly and fully set out in sufficient detail so as to enable a person skilled in the art to know and appreciate what they are.” That is, the judge found that it is “mere rhetoric” to only state the advantages of the invention in the patent specification.

And get this – Judge Hughes ruled on an argument that wasn’t even made by Novopharm. He invented and then ruled on his own argument.

Here's a link to Judge Hughes’ June 5, 2007 decision:

http://decisions.fct-cf.gc.ca/en/2007/2007fc596/2007fc596.html

(PS/ A Canadian appellate court chastised Judge Hughes' decision.)

A couple of crucial points:

Eli Lilly Canada Inc. v. Novopharm Limited raises a significant new question of law and represents a significant shift in the requirement for disclosure in patent applications that has an immediate impact on presently pending applications and patents-in-force in Canada.

Judge Hughes’ ruling is out of step with Canadian law; it violates international IP treaties (TRIPS, PCT), and makes Canada an outlier among all developed and developing countries.

For example, the Patent Cooperation Treaty (PCT) provides for the requirements of a patent specification and states that the “description shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art.” Considering that Canada is a member of the PCT, it seems that the Federal Court has now made Canada non-compliant with its treaty obligations.

Furthermore, by applying this “super-sufficiency” requirement to a certain class of improvement patents (so-called “selection” patents); the decision also violates the nondiscrimination clauses of TRIPS. TRIPS requires that the standards of patentability for all technology must be the same. In addition, by applying this requirement only to selection patents, the legal requirements in Canada now improperly establish a higher standard of patentability for this type of innovation in contravention of the non-discriminatory clauses of TRIPS.

And, even worse, the Court of Appeals in Canada has created a practice of dismissing any adverse ruling against the pharmaceutical patent as being moot if the generic obtains its marketing approval before the appeal can be heard. So, a generic challenger has their day in court and a full opportunity to appeal a ruling. The innovator pharmaceutical company has their day in court with the first challenger and if there is an adverse ruling will have no opportunity to appeal. To further exacerbate matters, the Court of Appeals has also held that once the first generic challenger has prevailed subsequent challengers should also be granted an approval.

So much for checks and balances.

These actions are manifestly unfair to the research-based pharmaceutical industry and will chill pharmaceutical innovation in the Great White North. This illegal and unfair attitude, if it continues unfettered or unquestioned, will lead to fewer innovative pharmaceutical products being made available to Canadians.

Ah, those pesky unintended consequences.  Read More & Comment...

What time is it at the FDA?

06/29/2007 08:40 AM |

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

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

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

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

Chou would have made a great regulator.

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

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

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

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

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

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

That's SMOKED Salmon

06/28/2007 05:58 PM |

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

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

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

Michael Moore's Sick Message

06/28/2007 01:27 PM |

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

Read article here
  Read More & Comment...

The Whack Pack's Perverse Priorities on Drug Safety

06/28/2007 08:18 AM |

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

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

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

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

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

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

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

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

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


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

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


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

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

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

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

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

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

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

The Sludge Report: More Mewlings From Peter Rost

06/27/2007 06:03 PM |

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

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

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

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

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

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

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

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

www.aidsmap.com

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

Pharmonic Convergence

06/27/2007 12:41 PM |

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

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

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

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

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

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

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

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

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

Indeed.

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

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

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

Measure THIS!!!

06/27/2007 10:59 AM |

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

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


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

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

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

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

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

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