Phase Fore!

04/25/2008 08:47 AM |

Steve Walker of the Abigail Alliance weighs in on the issue of timely commencement of promised Phase IV trials:

"I think in some cases you are probably right about the failure to conduct Phase IV studies being a "self-inflicted" wound, but there is perhaps a bigger problem in the design of a lot of the studies.  Once a drug is approved and deemed safe and effective (in many cases proven in compelling fashion despite the absence of a perfect p-value), conducting randomized studies where patients are randomized into treatment arms that do not serve their best medical interests is fraught with all kinds of ethical and practical problems, and challenges for sponsors, physicians and doctors.  Coupled with the undeniable fact that after approval the development and learning process about many drugs accelerates dramatically (a good thing that usually leaves the slow-moving FDA far behind) often causes the trials mandated by FDA to become obsolete before they start, and even more commonly before they are completed.  When that occurs, the FDA's and other's mandates that the trials be conducted anyway degenerates into nothing but a form over substance pursuit of compliance for no other purpose than compliance.  That should not be the purpose of the regulation of medical products because it is harmful to the public health, not to mention a waste of money and patients.   Read More & Comment...

Bayh-Bayh To Another Barrier to Euro-Innovation

04/24/2008 06:13 PM |

From our friends at www.Fastercures.org...It looks as though Europe is tearing down another anti-capitalist wall: the one between academia and industry that slowed translation of biotechnology into products.  How?  By using the same approach that President Reagan took by expanding the Bayh-Dole through executive order with Federal Technology Transfer Act.  That put government agencies on notice to share all patentable technologies with the private sector to promote investment al presto. 

This will make the pharmaceutical purists and conflict of interest capos sick am I sure.  There is now nowhere in the world where their views have been turned into policy or law...except North Korea or Cuba.   Here's the post from Fastercures Smartbrief...

EC wants more research headed to product development
The European Commission is asking for more interaction between universities and pharmaceutical companies to ensure that research knowledge is more quickly translated into products and services. The EC adopted a recommendation on how member states can revise their policies to allow public research organizations to leverage intellectual property more effectively. In-PharmaTechnologist.com  Read More & Comment...

Wood That Everyone Had Same Sane Views on the FDA

04/24/2008 05:33 PM |

Alastair Wood's excellent editorial in the NEJM, rising above the hysterics with wit and intellect:

content.nejm.org/cgi/content/full/358/17/1774  Read More & Comment...

Study Buddies

04/24/2008 09:27 AM |

According to Bloomberg (the news service not the mayor):

“Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators. The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.”

Here's a link to the complete story:

www.bloomberg.com/apps/news

Yes, I know, it’s not that simple – but that being said, it’s true.  And that has to change.  While this issue does play into the hands of the usual suspect safety jihadists (note quote in article by Peter Lurie) – promised studies should be commenced promptly.

Yes, there are many relevant and extenuating circumstances (note quote from PhRMA), but, as far as industry is concerned, this is a self-inflicted wound that spin cannot fix.


  Read More & Comment...

EU Considers Merging onto the Healthcare Information Superhighway

04/24/2008 07:54 AM |

Maybe it has something to do with the strength of the Euro -- or maybe it has something to do with a patient's right to know.  And just maybe things are beginning to change.

Have a look at this new article (from the Journal of Life Sciences) on how the EU is pondering changing what's allowable vis-a-vis what they call "Information to Patients" and we in the US call "Direct to Consumer Communications:

www.tjols.com/article-640.html

Bottom line -- knowledge is power.

  Read More & Comment...

Gene -- but not heard

04/23/2008 08:05 PM |

Finally we are going to settle the issue of genetic testing and personal privacy.  And it's about time. 

According to Andy Pollack's story in today's New York Times:

"Proponents say the new law, more than a dozen years in the making, would help usher in an age of genetic medicine, in which DNA tests might help predict if a person is at risk of a disease, allowing action to be taken to prevent it.

Some of the tests already exist, like one for breast cancer risk, and new ones are being introduced almost every month. But backers of the legislation say many people are afraid of taking such tests because they fear the results would be used to deny them employment or health insurance.

“This bill removes a significant obstacle to the advancement of personalized medicine,” said Edward Abrahams, the executive director of the Personalized Medicine Coalition. His group is an organization of drug and diagnostic companies, academic institutions and patient groups that advocate using genetic information to choose the most appropriate treatment for each patient."

Here's the rest of the story:

www.nytimes.com/2008/04/23/business/23gene.html

All sounds good, right?  Hopefully. 

We'll wait and see, when the payer is the government , if Uncle Sam retains the same "keep your hands outta my genes" philosophy.

But, in the meantime, well done.
  Read More & Comment...

Heparin Hypocrisy - Hyped Up Safety Fears on ADHD Drugs -Does Medicaid Kill Poor People

04/23/2008 07:17 PM |

Yet another show trial held by another congressional committee on the FDA...There have been four or five over the last two months on heparin alone. Andy von Eschenbach, who is gaining momentum, along with the FDA, in shifting the agency towards a science and systems based approach to regulation -- using real time technology to promote full time compliance -- has to sit and take the following from the likes of Bart Stupak (D-Michigan):

"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."

That's rich coming from a guy who helped push up the suicide rates by scaring parents away from antidepressants. and who is pushing for drug importation at a time when Al Qaeda and Hezbollah are involved in drug counterfeiting....Andy must have to shower after sitting through such a show trial...

www.fraudaid.com/scamspeak/conprods.htm

Meanwhile the Steve Nissen fear factory spews out another piece of tabloid medicine: EKG monitoring of all kids getting stimulants for ADHD.. Now there's a way to achieve Nissen (who has never studied ADHD) goal of making a physician's hand quiver before writing a scrip for the drug....But will it improve prescribing? Ron Winslow of the WSJ nails it:

"Since 1999, fewer than 30 sudden deaths among children have been linked to the drugs, which are currently taken by more than 2.5 million youngsters in the U.S. Issues of cost, available expertise in reading children's ECGs and concern about false-positive tests are prompting some experts to question the rationale for urging an ECG in particular.

"This is a $250 million recommendation," says Mike Ackerman, a pediatric cardiologist at the Mayo Clinic in Rochester, Minn., who estimates the total cost of an ECG at about $100. "We're really trying to find a needle in a haystack, and we have no data yet to know that the screening program they're recommending would capture" those few at-risk individuals. Dr. Ackerman was a member of another American Heart Association panel that last year stopped short of recommending routine ECG screening for heart abnormalities in young competitive athletes."

Read the Wall Street Journal article

FInally a pattern appears to emerging that has escaped even the great John Wennberg: the life expectancy of poor people is declining even as that of others is increasing. Women in particular are dying earlier than men in rural areas. Can we say Medicaid and SCHIP anyone? And I should note that Frank Lichtenberg spotted a decline in life expectancy among the elderly in the VA, the same VA that Shannon Brownlee -- Wennberg's Boswell -- is pushing as the example of what we all should be forced into in the Dartmouth comparative effectiveness utopia. Eeech...

Here's the article by the ever wonderful Maggie Fox of Reuters with a link to the study which is pretty methodologically sound:

www.reuters.com/article/scienceNews/idUSN2146521720080422  Read More & Comment...

Foul Shots

04/21/2008 03:22 PM |

My latest article on the vaccine-autism mythology....

www.nypost.com/seven/04202008/postopinion/postopbooks/foul_shots_107320.htm
  Read More & Comment...

OMB & Healthcare Reform: Not so easy (and not so fast)

04/21/2008 12:36 PM |

Important article in today's Wall Street Journal on OMB's Peter Orszag.

Here's how it begins ...

As the presidential candidates and Congress rev up the debate over the future of health care, Peter Orszag is already playing one of the toughest positions: referee.

Mr. Orszag, a 39-year-old economist, is the director of the Congressional Budget Office, the influential agency charged with toting up congressional bills' impact on the federal budget. Such scoring can sink bills that can't offset their costs with savings -- a serious risk for proposals that aim to expand federal health programs to cover more citizens.

Mr. Orszag increasingly is focusing on health issues, taking an unusually high profile for his nonpartisan office. He has become a prominent speaker at health conferences and co-wrote two pieces in the New England Journal of Medicine. He has launched a blog, cboblog.cbo.gov/, boosted the number of staffers who work on health to 47 from 31 and is seeking to add more. The agency has 235 employees.

"This actually is our fiscal future, and policymakers do not have as much analysis and options as they would need to make sound long-term decisions," says Mr. Orszag.

Here’s a link to the complete article:

http://online.wsj.com/article/SB120874132955630171.html?mod=hps_us_inside_today

The CBO's health-care work "will be very instructive to members when we attempt to take steps to right the ship," says Sen. Kent Conrad, the North Dakota Democrat who chairs the Senate Budget Committee.

Indeed – but let’s also add to the equation short-term versus long-term issues.  And as obvious as that sounds, long-term often gets glossed over – particularly during a national election cycle – when "tough problems" (like safety and cost and rationing of care) don’t necessarily support more populist sound-bites like “importation” and “universal coverage.”

  Read More & Comment...

Gray Lady Gives Up the Ghost

04/21/2008 10:37 AM |

Over a year ago the Wall Street Journal published a piece “exposing” that some medical journal articles are – gasp – drafted by professional medical writers and then edited (often heavily so) by the bylined authors before they are published!

 

The New York Times must have missed it, because on Saturday the New York Times ran a very similar article.  All the news that’s fit to print? 

 

Here’s how Stephanie Saul began her article, “The pharmaceutical industry glimpsed its own ghost this week, and the apparition could not have arrived at a worse time for drug makers.”

 

Cute.  Here’s a link to the complete article:

 

www.nytimes.com/2008/04/19/business/19ghost.html

Ms. Saul’s represents only the latest example of the media positioning ANYTHING paid for, promoted, supported, encouraged, approved, or assisted by Big Pharma has BAD. And not just BAD but REALLY BAD. SO BAD, in fact, that it deserves the full evil empire treatment. The “issue” the article is pegged to is the FDA’s brave stance on the free and fair dissemination of scientific data (aka:  journal articles) by pharmaceutical companies to physicians and other audiences. According to Ms. Saul, this controversy (made new again by a report that Merck used ghost writers for journal articles relating to Vioxx) “raised new questions about the validity of many published research studies, even in peer-reviewed publications.”   I thought passive voice was a no-no in journalism?

 

The real question on the table is whether it’s right and appropriate for pharmaceutical companies to be involved in the drafting of medical journal articles that are based on their own studies of their own products.  Hullo?  Okay, let’s try this – how about, is it right and appropriate for pharmaceutical companies to blur the line between marketing and science?  That’s a better question, but it presupposes that all marketing is bad and all science is good. 

 

Let’s pursue that proposition.  Who would think marketing and science make poor bedfellows?  Well, cui bono? Surprise! The people at the front of the anti-marketing, pro-science queue are the editors of our medical journals.  After all, if these self-appointed Sultans of Science cease to be the singular gatekeepers of new scientific information then, quite logically, the world will come to an end.  The canard that ghostwritten articles in any way denigrate the nature of the material is such a transparent and disingenuous attempt on the part of medical journal editors to discredit the pharmaceutical industry that it is (or should be) embarrassing.  It brings into real question the better (Marcia) angels of their nature.

 

Other folks with an agenda here (and who are portrayed in the New York Times story as “advocates”) are those who have a vested interest in not having more expensive drugs available for patient care – aka payers.  And, of course, there’s the mandatory quote from Sid Wolfe.

 

Next time you read an op-ed in your favorite newspaper by a well-known personage consider if a ghostwriter was employed.  Answer:  Probably.  Next time you hear your favorite politician give an address ask yourself if the speaker wrote the speech.  Answer:  Probably not.  And then ask yourself this – does it make a difference?  If the article or the address truly represents the beliefs of the “byline,” then it’s like that TV commercial, “We don’t make a lot of the things you use.  We make a lot of the things you use better.”

 

Me, personally, I’d rather read articles that are well written. I also believe that if the incursion of professional writing assistance makes the articles better, then that’s a good thing because it tends to make dense data more easily understandable.

 

Isn’t that the point? Or is it just me?

  Read More & Comment...

Patents Passion and the Public Health

04/20/2008 03:19 PM |

When it comes to healthcare everyone, it seems, wants to talk about patents.

Congress wants to reform them.

The WHO wants to circumvent them.

Some, such as Bernie Sanders (the Senator from Ben & Jerry's) want to eliminate them.

All concerned address the issue with passion and an interest in improving global public health.

But, even with the best intentions, they're missing the point. We need to focus beyond reforming patent law. We need to rethink the existing system to encourage pharmaceutical innovation (both incremental and discontinuous) in order to realize the potential of the Biomedical Century.

And not just in the US -- but globally.

The solution isn't exclsively patent reform -- that's too narrow. We need to consider new strategies that enhance and protect intellectual property rights. What we need to seriously study -- and transnationally -- is the issue of data exclusivity.

There are some numbers that are too important to ignore. Today it takes about 10,000 new molocules to produce 1 FDA-approved medicine. And if that's not frightening enough, only 3 out of 10 new medicines earn back their research and development costs. And here's the kicker -- unlike other R&D-intensive industries, pharmaceutical investments generally must be sustained for over two decades before the few that make it can generate any profit.

Current patent life just doesn't cut it. Not in the US. Not in the EU. And certainly not via TRIPS.

If we don't think seriously about moving away from patent reform and towards more robust protection of data exclusivity we are going to seriously jeopardize the potential for new medicines -- at a time when science makes potential breakthroughs tantalizingly close.

Do we really want promising compounds abandoned because of awkwardly crafted and inconsistent (read "unpredictable") patent terms?

  Read More & Comment...

The Critical Path to Safer Drugs

04/18/2008 09:47 AM |

Robert Goldberg

Ray Woosley's pioneering collaboration with the FDA to move drug safety in to the 21st century are paying off...Let's see who objects...

From the San Francisco Chronicle....

The Food and Drug Administration is poised to throw its support behind a powerful new method of predicting the safety of experimental drugs, a step that could help pharmaceutical companies bring treatments to market more quickly - and reduce patients' risk.

The process being considered uses seven indicators - known as biomarkers - that signal kidney injury when found in the urine of test subjects.

"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," said Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, which is working with the FDA to safely speed drug development.

Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animals' reactions aren't always the best predictor of whether substances will be safe for humans. Drugs harmless to animals can hurt humans, and vice versa. If a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.

"Using current tests, you have lost about 70 percent of the kidney function before you pick it up," says William Mattes, director of toxicology at the Critical Path Institute in Tucson.

The new biomarker process has the potential to save a patient's kidneys.

The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.
Seventeen companies have joined the research into biomarkers at the Critical Path Institute. These include giants like Bristol- Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Co. and Pfizer. The companies contribute their expertise but, according to Woosley, the institute does not accept commercial funding.

Initially, the seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests.

"This qualification process allows the industry to have an accurate view of the application of these biomarkers in drug development. They are not replacing anything that is done today. But the goal, as we gather more and more information, is to eventually be able to include them in clinical trials," said Federico Goodsaid, senior staff scientist at the genomics group at the FDA Office of Clinical Pharmacology.

Goodsaid is responsible for the development of the FDA's biomarker qualification pilot process, which began about a year ago when 23 potential biomarkers for kidney damage were submitted to the federal agency. The evaluation process at the Critical Path Institute has since selected the seven most efficient ones.

Named for the risky period when a drug is taken from the preclinical stage into clinical trials, the Critical Path Institute was founded two years ago by the FDA in collaboration with University of Arizona and Menlo Park's SRI International to break a worrying trend within the pharmaceutical industry: In the past decade the number of innovative therapies submitted for FDA approval dropped by 50 percent, but the cost of drug development increased dramatically.

Meanwhile, scares like the one associated with the painkiller Vioxx, which turned out to cause heart attacks and strokes, have further fueled this trend.

Unique for the Critical Path Institute is that FDA is a cofounder. Today, the European Medicines Agency - an agency similar to the FDA - also participates as an adviser. The agency is expected to qualify the seven biomarker testing method simultaneously with FDA.

"This is the first time they have coordinated their decisions," Mattes said.

Sidney Wolfe, director of the health research group at Public Citizen, a nonprofit public interest organization, supports the use of biomarkers as long as they are properly validated. But he is critical of the FDA's attitude toward present drug safety tests.
"Findings of toxicity in the currently required animal tests are not taken seriously enough by companies or by the FDA," Wolfe said.
He cites two recent examples of drugs in trouble, both of which showed toxicity in laboratory animals: the diabetes drug Avandia from GlaxoSmithKline and Vytorin from Schering-Plough and Merck, a cholesterol-lowering medication.

"Avandia showed evidence of heart damage in animal studies and, for Vytorin, tests showed serious toxicity in laboratory animals, regardless of how low a dose of this combination drug was used," says Wolfe.

The official announcement of the qualification of the seven biomarkers for kidney injury is expected from the FDA any day.
"It is in a very advanced stage of that process," Goodsaid said. "We should have some news soon."

Posted by Robert Goldberg on April 17, 2008 4:40 PM   Read More & Comment...

McCain Straight Talk On Health Care

04/18/2008 09:45 AM |

Robert Goldberg

From his speech in Pittsburgh...

Americans also worry about stagnant wages, which are caused in part by the rising cost of health care. Each year employers pay more and more for insurance, leaving less and less to pay their employees. As president, I will propose and relentlessly advocate changes that will bring down health care costs, make health care more affordable and accessible, help individuals and families buy their health insurance with generous tax credits, and enable you to keep your insurance when you change jobs.

Many retired Americans face the terrible reality of deciding whether to buy food, pay rent or buy their prescriptions. And their government should help them. But when we added the prescription drug benefit to Medicare, a new and costly entitlement, we included many people who are more than capable of purchasing their own medicine without assistance from taxpayers who struggle to purchase their own. People like Bill Gates and Warren Buffet don't need their prescriptions underwritten by taxpayers. Those who can afford to buy their own prescription drugs should be expected to do so. This reform alone will save billions of dollars that could be returned to taxpayers or put to better use.

Posted by Robert Goldberg on April 17, 2008 4:21 PM  Read More & Comment...

Slamma JAMA

04/18/2008 09:43 AM |

Peter Pitts

What ever happened to dialogue and ... ethics?

In it's reporting/editorializing on the recent "what-did-Merck-know-and-when-did-it-know-it" saga, JAMA accuses some pretty high-powered healthcare professionals of shilling for shillings.

Now it comes to light that the folks JAMA denounced weren't even given the chance by the Sultans of Science to defend themselves.
Here's what the Washington Post says,

"Although the two studies question the integrity of dozens of physicians and scientists, the JAMA authors did not seek responses from them. Several of those people yesterday called the conclusions incorrect, incomplete or unfair."

Don't "real" journalists" seek out both sides of the story? Don't real scientists?

Posted by Peter Pitts on April 17, 2008 7:15 AM  Read More & Comment...

Kohl Play

04/18/2008 09:42 AM |

Peter Pitts

We've been saying it for years -- when it comes to FDA reform, the descant is "Show me the money!" And we're glad to say that the chorus has picked up some new members.

“To us, it’s clear that they’re seriously underfunded,” Senator Herb Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations subcommittee, headed by Mr. Kohl, that oversees the FDA’s spending.

The subcommittee’s ranking minority member, Senator Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew C. von Eschenbach, to say how much more the agency could use wisely.
If lawmakers decide that the White House “was wrong and you needed to add another $100 million, just to pull a number completely out of the air, could you handle that?” Mr. Bennett asked.

Dr. von Eschenbach said he would “welcome an opportunity to present a scenario of portfolio options” for levels of financing.
That's a nice way to put it.

Posted by Peter Pitts on April 16, 2008 6:59 AM  Read More & Comment...

Wennberg is Right: There Are Cheaper Ways to Die

04/18/2008 09:41 AM |

Robert Goldberg

From the ever interesting http://fiercehealthcare.com

A new study has drawn a conclusion that flies in the face of the core assumptions most planners make about healthcare. At least for some patients, shorter hospital stays aren't better, according to the study, which was published in this month's Archives of Internal Medicine. The researchers, who studied 15,531 Pennsylvania patients diagnosed with a pulmonary embolism, found that those who were discharged sooner were at greater risk of death. Specifically, patients discharged after four or fewer dies were much more likely to die than those remaining in the hospital for five or more days.

This definitely proves Wennberg's point about regional variation: There are cheaper ways to die. I guess he left figuring out the most effective ways to prolong life to others....

Posted by Robert Goldberg on April 15, 2008 1:17 PM   Read More & Comment...

Venture Capital Violates Academic Virginity

04/18/2008 09:40 AM |

Robert Goldberg

According to the conflict of interest kapos, academics should have no industry money since it is corrupting. Imagine what venture capital which showers profs with options and seeks 50 percent returns will do!!

According to FasterCures...it leads to robust commercialization of of important new technologies...

"Partnerships between venture capitalists and inventors from academia may be an effective way to commercialize drug and medical-device research. This approach is exemplified by the success of Polaris Venture Partners, whose collaboration with Robert Langer, an expert affiliated with the Massachusetts Institute of Technology, has produced 13 companies over the past 15 years."
Money supporting important medical ideas. As in the Cystic Fibrosis Foundation and VC firms funding academics to find cures for CF who themselves might profit from the companies they set up. Sickening...to the conflict of interest connect the dot capos at http://pharmalot.com, http://healthcarerenewal.com, etc., etc.

Posted by Robert Goldberg on April 15, 2008 1:10 PM   Read More & Comment...

Real Time Reporting on Drug Effects-Reality not Rhetoric

04/18/2008 09:38 AM |

Robert Goldberg

For those who think that real time reporting of how drugs work in people will lead to a mass of lawsuits, one size fits all drug switching and drug withdrawals think again. From a WSJ article on a Wellpoint-FDA drug data sharing program:

"Contrary to the meta-analysis, WellPoint's initial findings didn't necessarily indicate a higher heart-attack risk linked to Avandia than to Actos and other diabetes medications. Now the company is broadening the data search to examine the safety question further. (The insurer says the study wasn't sponsored by Glaxo or another drug company.)"

Any comment Dr. Nissen or are you too busy offering protection to companies with what will be yet another outdated approach to drug safety?

And HMOs will find it harder to shove patients into drug silos...so much for comparative effectiveness....

"Kaiser also has performed its own safety and efficacy tests on FDA-approved drugs before placing them on its formulary. Within the past six months, for example, for instance, it studied whether a particular generic version of the blood-thinner warfarin was as safe and effective as other versions. David Campen, medical director of Kaiser's Northern California pharmacy operations, said it took the precaution before price negotiations with the generic's maker, given that even slight dosing changes in warfarin can cause harsh side effects."

Wait till genetic tests are broadly available.

Reality bites, especially when you are trying to use one size fits all studies to squeeze savings out of health care....

http://online.wsj.com/article/SB120822459568214991.html?mod=health_home_stories

PS...The FDA should be applauded for leading the way in this effort.

Posted by Robert Goldberg on April 15, 2008 12:58 PM  Read More & Comment...

Evidence-based Rx miscues

04/18/2008 09:35 AM |

Peter Pitts
From today's Washington Times ...

"Evidence-based" Rx miscues

Hillary Clinton, Barack Obama and John McCain have been traveling the country laying out their solutions to the problem of escalating health-care costs. One plan they all favor is ramping up federal funding for so-called "evidence-based" medicine.
The theory behind evidence-based medicine is simple: If the government were to run clinical trials testing the effectiveness of drugs and medical technologies, and then use the results to determine what to cover, taxpayers would avoid paying for treatments that aren't effective enough to justify their price tag.

Sounds great, right? Too bad that in practice, evidence-based programs are largely driven by the political imperative to cut costs — not the medical imperative to give patients the best care possible.

That was certainly the case for CATIE, or the Clinical Antipsychotic Trials in Intervention Effectiveness. This federally funded, $40 million study concluded new "atypical" nonpsychotic drugs are no more effective at treating schizophrenia symptoms than are older drugs. Because this finding flatly contradicted psychiatrists' real-world observations, CATIE had no impact on which drugs were prescribed for schizophrenia.

Like most large-scale trials, CATIE took a one-size-fits-all approach to medicine. Evidence-based programs encourage this approach. The underlying assumption is that the same care can be applied to every patient suffering from the same disease.
Modern science disproves that notion. Everyone has a unique biological makeup. Health-care professionals need to be given the autonomy to tailor their treatments to the specific needs of their patents.

Evidence-based programs rarely provide that autonomy. In the long run, this often results in higher costs.

Consider an overweight man who is forced to take a cheaper, less effective anti-cholesterol drug. If he ends up in the emergency room because of undertreated cardiovascular disease, this could end up costing the health-care system significantly more money.
All too often, denying patients access to the right medicines early on means paying for more invasive and expensive procedures later.

The evidence confirms this. A study from the University of Utah examined the relationship between cost-containment programs and the total cost of health care for a number of medical conditions. It found that the tighter the restrictions on which treatments a physician could administer, the higher the overall cost of care.

Medical treatment should be based on the specific genetic, clinical and demographic factors of an individual patient. That's how you keep people healthy. In an era of personalized medicine, one-size-fits-all health-care strategies are dangerously outdated.
Choosing short-term savings over long-term results has a pernicious effect on the public purse and public health. Strenuous cost controls compromise patient care.

The theory behind and the practice of evidence-based medicine just don't match up. And until politicians can show how they'll resolve that tension, they need to look elsewhere in their quest to find politically palpable solutions to the country's health-care woes.

Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.

Posted by Peter Pitts on April 15, 2008 8:07 AM  Read More & Comment...

A Modest Proposal?

04/18/2008 09:32 AM |

Peter Pitts

In April of 2006, James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General) had this to say about rethinking the EU Commission’s position on information-to-patients:

“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.”

Copping continued as to possible ways to achieve that goal:

“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.”
Well, almost two-years to the day, the controversial EU-wide ban on pharmaceutical advertising may soon end – although what this means, precisely, is unclear, as is what kind of information may become available.

The European commission plans to allow drug companies to give "information" about their drugs to the public on TV, the internet and in print.

The consultation document from the enterprise and industry directorate-general says: "It should be possible for the pharmaceutical industry to disseminate information on prescription-only medicines through TV and radio programmes, through printed material actively distributed, through information in printed media or through audiovisual and written material provided to patients by healthcare professionals." The consultation period closed on April 7. An earlier Commission report had found unequal access to health and medicines information throughout the EU, which it said could be harmful to public health.

Leaders of the European pharmaceutical industry have once again stressed that they are not seeking, and have never sought, direct-to-consumer advertising for prescription medicines to be permitted within the European Union. However, according to Arthur Higgins (EFPIA president and chief executive of Bayer HealthCare AG.), “After years of debate, we call on all European institutions to develop a patient-centered EU framework for information provision without further delay.”

EFPIA is also concerned at the EU proposals for a governance system for monitoring the information provided by the industry. The Commission suggests that the structure of enforcement could take place on three different levels – an EU advisory committee, the EU national authorities and national “co-regulatory” bodies – but EFPIA believes that this could potentially lead to a “patchwork” of very different interpretations and implementations in national laws, as it is currently the case, and thus fail to adequately address the European dimension of the current shortcomings.

Instead, the industry proposes an alternative system based on an EU-wide “health information” Code of Conduct, including effective quality assessment procedures for information, ex-post control mechanisms (with involvement of third/independent parties) and robust enforcement procedures in case of breaches including sanctions as well as fines. Such a Code could work alongside and complement the legislative change envisaged by the European Commission later this year.

Posted by Peter Pitts on April 15, 2008 7:18 AM  Read More & Comment...