Vapid Vytorin Coverage Part 2

03/31/2008 11:59 AM |

And speaking of vapid coverage, an accompanying article in the NEJM that claims the higher use of Vytorin in the US was due to DTC provides no evidence of cause and effect or association. Rather, it does put it's finger on the real reason: Canada health system delayed and restricted access:


"Vytorin has been available in the United States since July 2004 but is still not available on the Canadian market. The use of ezetimibe-containing products in the United States increased sharply with the introduction of Vytorin. Some U.S. clinicians may have adopted the combination cholesterol-lowering product to improve adherence to dual therapy, but this option was not available in Canada. Third, in Canada, publicly funded provincial drug formularies have been conservative in their coverage of ezetimibe. Two of the three provincial government-funded formularies that serve three provinces (Ontario, Quebec, and British Columbia), in which approximately 75% of Canada's population lives, list ezetimibe with prescribing criteria that limit its use to patients in whom the target level of LDL cholesterol has not been achieved with a statin and patients who cannot tolerate or have a contraindication to statins; a third formulary does not even list ezetimibe as a benefit, although it is currently under review. These formulary criteria appear to be consistent with guideline recommendations that favor medication classes for which data on outcomes are available. Public formulary listings often influence medication coverage in private Canadian drug plans.

Oh.

But watch how many media articles cite DTC as the culprit. This is typical of the the quality of the case against DTC.
http://content.nejm.org/cgi/content/full/NEJMsa0801461  Read More & Comment...

Vapid Vytorin Coverage

03/31/2008 11:35 AM |

It would great if, just once, coverage about clinical trials focused on the unpredictability of science and the inherent difficulty of designing "real world" studies of the effect of drugs that produce desired results, particularly a measurable reversal in biochemistry that contributes to death.

That will not happen with Vytorin, except in the breach. To be sure the original:" these findings plus future biologic and clinical evidence could confirm that the benefits of lowering LDL cholesterol may depend not only on "how low you go" but also on "how you get there."
http://content.nejm.org/cgi/content/full/NEJMe0801608


This is a point that Eric Topol has been making since the first wave of ENHANCE data was released. See Eric's video on his blog:
http://blogs.theheart.org/posts/temple-of-the-ldl-cholesterol

In the end, Vytorin use will fall but for the wrong reasons. Absent information about "how to get there" before prescribing, LDL treatment will still be hit or miss. That's all the ENHANCE study showed. We know that reducing LDL is important but we still lack targeted treatments.  Read More & Comment...

Doctor, Reveal Thyself

03/31/2008 07:49 AM |

As many in this country are calling for a ban on the sharing of physician prescribing data -- our regulatory cousins in the United Kingdom are moving aggressively in precisely the opposite direction.

According to a report in the Financial Times,

The government is considering making public the full details of 700m prescriptions issued by general practitioners each year.

Publication could provide valuable new statistics to help improve treatment, fight "postcode prescribing" and hold GPs more accountable.

The proposal is sensitive, however, following embarrassing losses of personal information by government agencies in recent months. Medical specialists warn that detailed prescription data could also threaten patient confidentiality and undermine existing research databases.

The aim was "to determine whether it would be possible to make practice-level prescribing data more accessible to the private sector", the government said in an answer to a recent parliamentary question.

Sue Sharpe, head of the Pharmaceutical Services Negotiating Committee, which represents pharmacists, said, "I have concerns about patient and prescriber confidentiality" if the data were released more widely. She also commented that it could also lead to "aggressive promotion of prescriptions" by drug companies.

Here's a link to the complete article:

http://www.ft.com/cms/s/0/dea53df6-feba-11dc-9e04-000077b07658.html?nclick_check=1

Same issues as here at home, but a completely antipodal policy design.  Read More & Comment...

The Virtual House Call

03/31/2008 07:27 AM |

Dr. Marc Siegel, a senior fellow at the Center for Medicine in the Public Interest, is a practicing internist, an Associate Professor at the New York University School of Medicine and a fellow in the Master Scholars Society at New York University. Dr. Siegel is also a columnist for The Los Angeles Times and a frequent contributor to the Washington Post, USA Today, Slate, and many other publications. He is the author of False Alarm; the Truth About the Epidemic of Fear (top 20 books of 2005 - Discover Magazine) and Bird Flu: Everything You Need to Know About the Next Pandemic. Dr. Siegel appears regularly on CNN, the NBC Today Show, and the Fox News Channel. Dr. Siegel was a contributor to the U.S. Senate Finance committee investigation of the 2001 bioterror crisis.

In his essay, "The Virtual House Call," Dr. Siegel discusses many of the challenges facing the 21st century physician in the United States. Here is a free sample (yes, we here at drugwonks are still giving away free samples) of his discourse:

"I have a litmus test to check on my humanity. I call it the virtual house call. It isn’t an actual house call but it relies on similar notions of inconvenience in order to help a patient. Rarely do we have time these days to travel to a patient’s home. We must extend ourselves beyond our offices and our blackberries in caring for our patients in order to become truly empowered as physicians. This extension of self is the virtual house call.
Here is my litmus test: Every day I leave my office for a cup of coffee when I get restless. The coffee shop is one block south of where I practice. I ask myself what I would do if one of my patients, on his or her way to see me, suddenly collapsed right outside that same coffee shop I frequent and called my office from his cell phone while gasping for air.

Would I instruct my nurse to call 911, or would I run the same block I always walked?

Would I at least show as much commitment to my patient as I show to my caffeine habit?


I’ve never had to face this particular litmus test, but I certainly hope I would pass it. And each time I pick up the phone to check in on one of my patient, I’m conscious of a similar kind of litmus test. As I listen over the phone to the telling sounds of fast breathing or nervous coughing, I make determinations that my nurse or secretary could never make. I try to remain available, to not set strict limits. I’m convinced that continuity of care makes me a better doctor.

Dr. Siegel's entire composition can be found at both at the top of this page and at http://www.cmpi.org under the "Report" heading. The larger paper is titled, "The Hazards of Harassing Doctors."  Read More & Comment...

Flooding the Safety Zone

03/28/2008 12:59 PM |

The FDA is ramping up it's effort to monitor the safety of drugs through its Early Alert and REMS program. It could be that the constant release of information on safety will do two things:

First neutralize the fear mongering and it's impact of people like Steve Nissen (more on him later) by getting ahead of the curve early and often. Second, get people and doctors to think more generally about the risks and benefits of medicines as well as their proper use. Finally, maybe it will prod companies and insurers to offer genetic tests to increase safer and more tailored dosing and drug selection right off the bat...

Genomas for instance is developing a genetic test to predict and compare an individual's risk of getting muscle pain among atorvastatin, simvastatin and rosuvastatin. I have used the protoype for my statin selection. http://www.genomas.net

I was pretty critical about the Early Alert program at first, regarding it as not being science based. But maybe (is it possible?) I was wrong. I think that flooding the safety zone with information is useful. It would be great as part of the Alerts to note that incidence of safety problems as a percentage of total scrips to put things into perspective. Along those lines, we encourage everyone who cares about the safety and impact of their meds to sign up for Iguard.org, a patient community that shares information about the benefits and side effects of their drugs. You can enroll at www.iguard.org  Read More & Comment...

Just what we need, an even Dentzer Health Affairs

03/28/2008 11:40 AM |

No, really.

Health Affairs has announced that the NewsHour's Susan Dentzer will become the journal’s new editor-in-chief on May 1, 2008.

“It’s a great honor to be taking the reins at Health Affairs after John Iglehart and Jamie Robinson have done so much to make it the preeminent health policy journal of our time,” Dentzer said. “I’m delighted to become part of Project HOPE, and I look forward to working with the journal’s talented staff to continue to bring the best thinking and writing to bear on the top domestic and global health issues confronting us all.

Dentzer also serves on the Kaiser Commission on the Future of Medicaid and the Uninsured, and she is a member of the national advisory committee for the Robert Wood Johnson Foundation’s Investigator Awards in Health Policy Research. From 1993 to 2004, Dentzer was a member of the board of trustees for her alma mater, Dartmouth College, and she chaired the board from 2001 through 2004. As a Nieman Fellow at Harvard University in 1986 and 1987, Dentzer studied political economy, health economics, and business at the John F. Kennedy School of Government, Harvard Business School, and the Harvard School of Public Health.

Good luck Susan.  Read More & Comment...

A new FDA story? Fill in the blanks.

03/28/2008 08:21 AM |

Why even bother having an FDA reporter when writing an FDA “expose” story is as easy as, well, Mad Libs.

New Report by (proper noun) Accuses FDA of (adjective) Oversight

Today (adjective) Citizens for (adjective) Health, a not-for-profit organization, released a (adjective) meta-analysis that (adverb) concludes the FDA, “is in the (noun) of (adjective) Pharma.”

“Our research of (number) concerned (plural noun) points (adverb) to an agency that has once again (verb past tense) the American public. It’s a (adjective) indication that the FDA places (noun) over (noun) and cannot be trusted to (verb) or (verb) – and certainly not (verb) in the public interest,” said the author’s report Dr. Sidney (type of animal).

“I find this new report both (adjective) and (adjective) – but (adverb) not (adjective),” commented Representative Henry (proper name).” “And I intend to hold televised (plural noun) on the matter.”

“This is just another (adjective) example of the FDA’s lack of (adjective) (noun), added Dr. Steven (name of automobile company). If I were the FDA Commissioner this (adjective) circumstance would never have occurred.”

In an embargoed editorial, the New (place name) Journal of Medicine opined that the (adjective) problem “is caused by the Prescription (noun) User-Fee Act and made even (adjective) by the agency’s continued (verb) of direct to (noun) advertising.” The editorial also points to the need for (adjective) importation of prescription (plural noun) from (name of country).

Supporting this notion, the AAR(letter) added that (adverb) high (plural noun) for drugs are a result of the (type of shrub) Administration's (adjective) program known as Part (letter) and supports (adjective) government (verb).

The FDA had (adjective) comment.  Read More & Comment...

If I were a Carpenter

03/28/2008 07:07 AM |

If I were a Carpenter or a Zucker or an Avorn, -- the three amigos who penned “Drug-Review Deadlines and Safety Problems” (NEJM, 2008; 358: 1354-61) – I’d be greasing up the old spin machine.

Consider the following from BioCentury Extra:

FDA refutes PDUFA safety study

FDA officials on Thursday criticized a study published in The New England Journal of Medicine that reports a statistically significant association between drug approvals near PDUFA deadlines and post-market safety problems.

The paper, by Daniel Carpenter of Harvard University and colleagues, concluded that drugs approved in the two months prior to their PDUFA deadlines were more likely to be withdrawn for safety reasons, to carry a subsequent black box warning, and to have one or more dosage forms discontinued by the manufacturer compared to drugs approved earlier or later. "Taken together, these findings suggest potential adverse effects of the deadlines governing FDA drug review," the paper said.

Clark Nardinelli, director of the economics staff in FDA's Office of Planning, told BioCentury that the agency has identified "at least two fundamental problems with the authors' data. We don't think their conclusions hold up." The paper misclassified a number of reviews as standard that actually had shorter deadlines because they were priority reviews, according to Nardinelli. When the reviews are classified correctly, the association between approvals near PDUFA deadlines and increased safety problems disappears, he said. The paper also understated the number of black box warnings, Nardinelli said. FDA plans to submit its data and conclusions to the NEJM and publish them on its Web site, spokesperson Christopher DiFrancesco said.

And all this time we thought it was the pharmaceutical industry playing fast and loose with data sets.

Well, as they say in Harvard Yard, "veritas."

We look forward to the FDA’s review … and hopefully to an apology from the authors and a retraction from NEJM.

Yeah, right.  Read More & Comment...

REMS brûlée

03/27/2008 02:49 PM |

FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs
and Biologics

New FDAAA requirements being implemented

The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.

Certain drugs present a dilemma: They can provide an important benefit to patients, but they can be especially dangerous if not used properly. For example, certain drugs may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage. Rather than deny FDA approval of such drugs, the agency has granted approval and required that the manufacturer develop a safety plan, or REMS, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. While FDA has previously approved some drugs and biologics with these safety plans, the new law makes explicit FDA’s authority to require them and contains specific enforcement authority when violations or noncompliance with the plan's requirements occur.

“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,” said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.”

In addition to issuing this Federal Register notice about drugs approved before March 25, 2008, the FDA also is implementing the new authority for drugs that will be approved after March 25, 2008, as well as for already marketed drugs for which new risks are identified after March 25.

The FDA also advised the public to notify the agency if they believe other drugs should be considered to have REMS under the new statutory provisions.

The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at:

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf

One of the named products is Mifepristone -- the infamous "abortion pill." So now we'll see if "safety" and "choice" can live side-by-side.  Read More & Comment...

The Organizational Man(tra)

03/27/2008 07:15 AM |

Health policy analysts, physicians, pharmaceutical company executives, business leaders and government officials recently met in Washington at the CMPI-Duke University Patient-Centric Leadership Forum to discuss developments in this exciting field.

Previously we have shared some of the comments made by noted cardiologist Dr. Michael Weber (“Weber Grills”):

http://drugwonks.com/2008/02/weber_grills.html

and Dr. Ralph Snyderman, Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine (“The Greening of the American Health Care System”):

http://drugwonks.com/2008/03/the_greening_of_the_american_health_care_system.html

Today we are, as always, honored to share some of the comments offered by the hardest working man in American health care, Dr. Mark McClellan.

“We’ve got a healthcare delivery system that is organized the wrong way. It provides the wrong services with the wrong emphasis to get to personalized, predictive, preventative care. You can trace this back to the fact that reimbursement is wrong. We have payment incentives that encourage more intensity, especially after a health problem has developed and don’t have any real accountability for getting better results for patients’ health at the lowest overall cost. We have systems of choice in our healthcare system that don’t really give people a choice, where the policies, the coverage that you can get, is influenced by many factors beyond an individual’s preference.

There is a lot of potential for more targeted therapies, more prevention-oriented treatment strategies, more individualized predictive medicine. This is why I’m fundamentally optimistic about the future of our healthcare policies. As there is so much potential on the side of personalized, predictive patient-centric care, the discoveries are going to happen.

The question is simply how fast, and how quickly are we going to get to really irresistible pressure for the kinds of reforms that will close the gap between what we could do with the right reimbursement rules and the right ability for patients to choose their care?"

Yes, that is the question.

Full conference remarks will be available shortly. Watch this space for more details.  Read More & Comment...

Janet vs. Jerry

03/26/2008 12:53 PM |

Jerry Avorn ran a statistical analysis in the NEJM showing that there were more black box warnings and discontinuations after PDUFA than before.

If he is trying to show that PDUFA means unsafe drugs he is making a logical leap not supported by his numbers crunching. Increased black box warnings are a result of greater vigilance and post-market review. And lumping discontinuations with black boxes is a slick statistical trick to mask the fact that product removals as a percent of all new molecular entities has remained fairly stable at 2-3 percent for decades and after PDUFA. Ask the FDA.

Meanwhile Janet Woodcock underscores what is really at the heart of the current slowdown in drug approvals and greater scrutiny: we know more and understand more. And often companies dump too much data on the FDA that is not informed by what we know but by what companies thinks the agency wants.

On the other hand, what explains the fact that some important medicines have received European approval even as they languish at the FDA? To be sure, Europe has often approved new drugs first and faster. However it is hard not to believe that having Grassley, Waxman, Stupak looking to turn new drug into a new scandal is slowing things down....

The Critical Path should lead to more science-based and population specific standards. But don't expect Avorn or any FDA commissioner wannabe to be satisfied...

http://www.ft.com/cms/s/0/7ae3646a-fad6-11dc-aa46-000077b07658.html?nclick_check=1

http://online.wsj.com/article/SB120648160360663519.html?mod=googlenews_wsj  Read More & Comment...

The Durbin's in the Detailing

03/26/2008 09:14 AM |

Senators Dick Durbin and Herb Kohl are proposing a federal grant program to allowing the hiring of physicians pharmacists and nurses who would to come up with "objective" promotional material (there's an oxymoron) about prescription drugs. These tax-payer paid reps would also go to doctor's offices to counter the promotion and use of higher-priced brand drugs that -- as the Senators claim -- are no more effective than generic versions.

If the goal is to increase generic prescribing shouldn't the generic industry be paying for these reps and the information? And if health care costs are the problem, why not send government paid reps to discourage use diagnostics, surgery and other services that are growing more rapidly than drug spending?

Oh wait, that's called rationing.

http://www.fiercehealthcare.com/story/senators-plan-bill-countering-pharma-detailing-tactics/2008-03-14  Read More & Comment...

Claire and Present Danger

03/26/2008 07:25 AM |

Senator Claire McCaskill (D, MO) thinks that the FDA’s draft guidance on off-label communications is "a startling potential change in policy.”

Um, no.

Someone should point out to the Senator that the “policy” that counts here is the First Amendment -- and there’s no question that it applies to commercial free speech. Judge Royce Lamberth (US District Court in DC) unambiguously ruled that restriction of off-label information, especially peer-reviewed journals, violates the First Amendment.

So much for the “startling change of policy.” (Was the Senator not briefed on this issue before she made her pronouncement? Sloppy staff work.)

Or, to quote Stephen Mahinka (veteran health care attorney and partner at Morgan Lewis), for the Senator (and her best pal Jerry Avorn) to imply a “startling change” is "intellectually dishonest or evidence that they are ignorant of the legal context.”

Ouch.  Read More & Comment...

Cost-Savings über Alles

03/25/2008 07:28 AM |

In CMPI’s new paper, “The Hazards of Harassing Doctors:Regulation and Reaction in Trans-Atlantic Healthcare," Dr. Alphonse Crespo, a Swiss physician, points out that focusing on cost-savings rather than patient care has unintended – but highly predictable consequences:

“Obsession with cost-containment has brought about regulatory measures that significantly affect the independence of German doctors. The “Drugs Saving Package” voted by the German parliament, introduces penalties for prescription of “expensive” drugs and rewards physicians who restrict their prescriptions to low-cost copy generics. This ethically objectionable legal gimmickry - akin to bribing physicians not to treat to the best of their ability - was one of the sparks of the doctor protest movement. A recent survey suggests that 65% of German physicians condemn bureaucratic tampering with prescriptions. Public perceptions echo their concerns. Questioned on this issue, 60% of people at large reckon that they will no longer get the best possible treatment from their doctors. Judging by media coverage, most Germans sympathize with their doctors' plight but express scepticism as to their ability to influence government health care policy and budgeting.”

Dr. Crespo’s complete essay and the complete paper can be found under the “Reports” heading at http://www.cmpi.org.  Read More & Comment...

Failing to Connect the Dots on Drug Safety

03/24/2008 11:38 AM |

How can the WSJ run a piece on using genetics to redirect failed medicines to smaller groups of patients that are high responders and then engage in an orgy of second guessing about Vytorin? The Vytorin case is a clear example of seeking ways to personalize medicine and stratifying statin therapy according to particular pathways...but the thirst for headlines trumps science-based reporting.

http://online.wsj.com/article/SB120632582431058683.html?mod=home_health_right


DItto FiercePharma's continuing fearmongering on SSRIs.... It cites an "expert" who claims "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent."

But the "expert" is none other than David Healy, whose flawed study about SSRI's and suicide triggered a series of events which lead to less SSRI use and more suicide. And Healy makes millions shilling for trial attorneys as an expert witness.

Some expert. Some reporting.

http://www.iht.com/articles/ap/2008/03/24/europe/EU-MED-Drug-Data-Laws.php


http://www.fiercepharma.com/story/could-full-data-disclosure-avert-scandal/2008-03-24?utm_medium=nl&utm_source=link  Read More & Comment...

Failed Drugs or Failed Pathways?

03/24/2008 08:38 AM |

Interesting article in today’s Wall Street Journal on the use of genetic tools to resuscitate failed compounds.

Here how the story begins:

“As pharmaceutical makers find it increasingly difficult to bring new drugs to market, they are turning to genetic tools to seek uses for medicines that failed to make it out of the development pipeline.

The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.”

And here’s the rest of the story:

http://online.wsj.com/article/SB120631682077958247.html?mod=dist_smartbrief

The better understanding of genetic tools (via a robust collaboration of industry, academia, and government) will both expedite failure (which lowers the cost of R&D) and provide a broader spectrum for success (which rewards it).

Sound familiar? Correct – the Critical Path.  Read More & Comment...

Follow-on, Oh Canada

03/24/2008 07:05 AM |

Our regulatory cousins to the north have begun the process of creating a biosimilar regulatory framework.

Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics” once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.

Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product.  Read More & Comment...

Counter-Detailing the Gray Lady

03/21/2008 07:08 AM |

Two interesting reader comments on the issue of government-sponsored counter-detailing as discussed in yesterday's blog entry "Close(d) Encounters."

Names have been withheld to protect the intelligent:

Dear DrugWonks:

What I think is interesting is whether this will become part of P4P proposals. If the government funds these counter-detailers, what happens if a physician refuses to see them? Are they reported to CMS? Are there repercussions for those physicians? Will they get more reimbursement if they see the government counter-detailers? If generic prescribing habits are part of P4P, as some propose, will this be part of it as well. Interesting to think about.

Dear DrugWonks:

I’d want to make sure the gov't detailers have to go by the same rules as the Rx companies -- FDA approved claims, FDA approved materials, no off label etc. Isn’t more info good?

PS, good luck getting a gov't employee to get in to see a doctor without pens and pizza if they don’t have cutting edge science to share

And if pharma detailers drive up the cost of Rx, won’t their detailers do the same?  Read More & Comment...

NIH HIV Trials: Essential Inaction

03/21/2008 06:06 AM |

For those in Soros/Essential Action camp who fervently believe the way to develop drugs for global health is to have the government coordinate and run trials with IP seized from private companies, the latest HIV vaccine failures underscore the ideologically riven fecklessness of their position.

The notion that prizes to investigators plus a pittance to those who develop and manufacture medicines under a government-run clinical trial operation will yield breakthroughs is naive: the risky part, the hard part, the part requiring hundreds of billions of dollars a year, is development. That is why commercialization is critical to medical progress, as are profits.

The Soros/Essential Action model is based on hatred of capitalism not science. And in the end, it will doom the dying around the world to continued suffering. The groups will have their press clippings and accolades from the Left and those in need of breakthroughs will have nothing. Such is the perverted definition of "progress" advanced by George Soros and Essential Action  Read More & Comment...

Close(d) Encounters

03/20/2008 03:14 PM |

Did you see the house editorial in today’s New York Times, “Countering the Drug Salesmen”?

Here’s the link:

http://www.nytimes.com/2008/03/20/opinion/20thu2.html?_r=1&ref=opinion&oref=slogin

The editorial supports planned legislation by Senators Herb Kohl, Democrat of Wisconsin, and Richard Durbin, Democrat of Illinois that would authorize federal grants to prepare “objective” educational materials designed to provide physicians with “unbiased” guidance on the safety and effectiveness of drugs. Such materials, along with a government-funded “counter-detailing” force are meant to offset the one-sided sales pitches America’s physicians get from pharmaceutical company representatives. The Times believes that, “The end result should be better care, quite often at lower cost.”

The Times shares the hope of Senators Kohl and Durbin that this government-funded scheme “would pay for itself by lowering drug costs to federal programs.”

Perhaps, but at what cost to patient care? And what about the fact that “unbiased” and “objective” are in the eyes of the beholder?

Clearly pharmaceutical companies detail because they believe it is in the interest of both the public health and their own commercial imperatives. Nothing wrong with that. Self-interest and public interest are not mutually exclusive.

But it’s only honest to point out that the government has significant self-interest too – Uncle Sam is the largest “payer” in the nation. So the more drugs these government-funded workers classify as "wasteful," the more money the government saves. Such a conflict is hardly" unbiased.”

Ultimately, as the European model has shown time and again, budget analysts and Big Brother-funded anti-pharmaceutical “truth squads” will deliver the findings their “funders” wants to see -- that newer, pricier pills are no more effective than their older, cheaper counterparts. And the result will be the same as well -- Medicare, Medicaid, and the Department of Veterans Affairs will stop covering these more innovative medicines, forcing physicians to prescribe only the drugs that the government will pay for, not the ones that are best for patients.

That’s what “government” care really delivers.  Read More & Comment...