Vytorin Prevents Dementia?

08/04/2008 02:03 PM |

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Dogmatic Day Afternoon

08/04/2008 11:41 AM |

Much hand wringing and speculation over the FDA’s recent Vanda decision. And the big question being asked is:

Is this the end of the dynamic duo of safety/efficacy and the beginning of a new Holy Trinity that includes comparative effectiveness?

Most reporting went something like this (courtesy of the Washington Post):

“Vanda Pharmaceuticals' stock tumbled 73 percent Monday after federal regulators rejected the Rockville biotech's schizophrenia treatment, saying it was similar to a drug already on the market.” (My italics.)

In fairness, the FDA didn’t actually say anything. This is how Vanda chose to represent the communications it received from the agency.

But rather than looking at this through the lens of comparative effectiveness – perhaps a better way to think about it is via comparative safety. Should inferior performance in some settings (for example if you won't know about it for weeks) be a molecule killer? The debate isn’t only (or primarily) whether it's bad to be worse – but also whether it can be easily monitored.

A tough situation for the FDA and a potential opportunity for those who would exploit this situation to call for a NICE-like system in the U.S. – such as Senators Baucus and Conrad and their “Comparative Effectiveness Research Act of 2008”

But it’s really just the latest example of why dogmatic approaches to drug regulation don’t work -- and why the Critical Path program is so essential.

Nobody said the FDA’s job was an easy one.

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Giving Drug Enforcement a New Meaning and Mission

08/01/2008 12:26 PM |

"The government could start paying impartial experts to visit doctors to talk about the safety, effectiveness and cost of prescription drugs and other treatments.

The idea would be to give presentations along the lines of those given by company drug reps. But the federally funded presentations would provide a counterweight to the industry messages on specific drugs.

A bill to that end is likely to be introduced today in both houses of Congress, according to the Prescription Project, a nonprofit that backs this sort of thing."

Impartial? Hardly. Right off the bat bias is built in...the government subsidized detailing will reduce drug costs..or else? Already a conflict of interest is introduced..the federal drug reps will be beholden to Senators Kohl, Grassley who have one objective...using detaiing to restrict the use of brand drugs.

And who will benefit? I noticed the Prescription Project supports the measure. No coincidence that Jerry Avorn who runs his own academic detailing company and contracts with state Medicaid agencies is an advisor to the Prescription Project, which in turn benefits from suing drug companies. And Avorn using ALLHAT as an example of conflict free prescribing. Problem is, ALLHAT undertreats most African Americans who have stroke.

This is beyond academic medicine rent seeking behavior as the previous post pointed out...this is a power grab that punishes patients. Worse, can you imagine have federal drug reps reporting on the who, what and where or what doctors are doing... Talk about a pharmaceutical police state..Don't like what docs are prescribing, call in DEA 2.0

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EBM? More than "a feeling"

08/01/2008 11:26 AM |

A new study in the Journal of Public Health shows that German physicians have "a feeling" when evidence-based medicie is being used as a cost containment tool rather than a clinical tool to improve patient outcomes. The study also indicates that for certain disease states (i.e., diabetes) EBM may play a greater role than in others (i.e., CNS ).

Here’s the abstract:

Background

In Germany, evidence-based medicine (EBM) is increasingly used to standardize medical decision making and patient treatment. As a consequence this development leads to a shift of influence in health care decision making from physicians to institutional representatives, payers and health care policy makers. However, EBM’s practical role in day-to-day patient care is less clearly defined.

Aim

The aim of this study was to evaluate a potential difference between EBM assessment of therapy benefits and empirical judgment by prescribing physicians and their patients.

Methods

Interviews were conducted with practicing physicians to evaluate reasons for selecting treatments and attitudes towards EBM. The physicians’ view was complemented by a patient telephone survey evaluating treatment satisfaction in selected indications.

Results

The findings of the physician survey suggest that many general practitioners (GPs) as well as specialized practitioners in Germany do not share EBM’s paramount concern with clinical effectiveness, but see it as one aspect in a wider concept that also includes patient-oriented concerns such as patient satisfaction, minimal infliction on patients’ day-to-day life and incompatibility with other needs or treatments. Another important finding is the notion that EBM is misused by health care policy aimed at restricting clinical practice options by focusing entirely on clinical effectiveness without considering the complex physician-patient interaction required for implementing a successful treatment process. Results from the patient survey reveal the patients’ expectation that their individual needs as well as their personal experiences with a given therapy are being considered and that a dialogue between patient and physician shall guide the course of treatment with the aim of finding an optimal balance between EBM-derived therapy effectiveness and individual, patient-based assessment of a particular treatment approach with respect to entirely subjective impressions and judgments.

Discussion

The results of this study demonstrate that practicing physicians consider not only evidence-based information, but also patient-oriented criteria to achieve adequate patient care and compliance. Patients wish to discuss disease and personal therapy experiences with their physician and emphasize their intention to actively participate in the treatment process. Therefore, the concept of patient-based medicine is proposed as an extension of current EBM practice in everyday patient treatment as well as for regulatory decision making regarding health care services.

Here is a link to the article

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Mr. Deats Goes to (London) Town

07/31/2008 10:51 AM |

From a recent press release issued by our regulatory cousins over at the MHRA:

LONDON MAN FINED FOR ILLEGAL INTERNET SALE OF MEDICINES

Mr Hafid Essadki (39) formerly of 341 Boardwalk Place, Trafalgar Way, London, E14 5SQ was fined £1,000 and ordered to pay £1,500 costs at Snaresbrook Crown Court for the illegal online sale and supply of Viagra and Cialis. The sentencing followed a prosecution by the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA started investigating Mr Essadki in January 2006 after receiving information from Pfizer that customers had complained about two websites advertising Viagra and Cialis for sale. On March 2006 MHRA enforcement officers, accompanied by representatives from Pfizer and Eli Lilly together with the Metropolitan Police, went to Mr Essadki’s home address and found a quantity of Viagra and Cialis tablets. These were seized along with computers, mobile phones and a laptop.

Mick Deats, Group Manager of Enforcement at the MHRA said, “The MHRA will not hesitate to take action against those who undermine public health. There is considerable risk to the public from obtaining medicines through unregulated websites. A medicine bought in this way has no guarantee of safety, quality or effectiveness. It could be counterfeit. It may not contain the right amount of medicine. At worst it may cause a severe side effect."

Jolly good work, right?  Well let’s look at this operation a little more closely.

First – the operation began in March 2006 – over two years ago. 

Second – the penalty is a total of £2,500.  And that includes “costs.”  Could the entire 15+ month-long investigation have cost Her Majesty only £1,500?  Such a deal!

Third – no jail time.  What kind of message does this send?

Answer:  It sends a very strong message which goes as follows, “Selling counterfeit drugs is a low risk/high reward business.”

Is that really the message we want to send?  Obviously not, since the MHRA’s Mr. Deats appropriately points out the real dangers of unsafe and unregulated products being sold over the Internet.

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Not Quite Human, So Let Her Die

07/30/2008 05:38 PM |

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Grassley and Dingell Introduce Anarchy

07/30/2008 04:36 PM |

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Nasty Rhetoric and Sloppy Reporting

07/30/2008 04:17 PM |

According to the Wall Street Journal, “Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. Leading the drive are Rep. John Dingell (D., Mich.) and his longtime friend in Congress, Sen. Chuck Grassley (R., Iowa).”

“The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry.”

Can anyone out there think of even one drug that the FDA wanted recalled that was not “voluntarily” recalled?

No – I didn’t think so.

(Also, isn't the FDA already an entirely independent government agency?)

FDA officials "are too cozy with the companies they regulate," Mr. Grassley said, adding that new leadership must "fix the culture."

What does “too cozy” mean? Really, what does it mean?

Senator Grassley believes the FDA Office of New Drugs, which he said has been compromised by its relations with industry lobbyists, among them former top FDA officials.”

And what does that mean? Any evidence to back up such blowhard accusations?

Too boot, here’s some really shoddy reporting by the Journal’s Alicia Mundy,

“Some current and former FDA safety reviewers have opened a whistleblower Web site to air their concerns that FDA leaders are pushing them to approve some drugs”

She is referring to www.thoreau-fda.com/index.php.

This site defines itself as “a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk.”

That’s nice. But when you check out to whom the site is registered, it turns out to be Jim Dickinson of FDAWeb.com – long-time FDA antagonist -- and no former FDA employee.

Oops.

But who needs facts when you have red-hot rhetoric and a gullible reporter who's willing to take a leak anywhere?

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Ringing the Federal Register

07/30/2008 01:16 PM |

Ya gotta love gov-speak. Bureaucrat-ese has its own unique and lovely lilt.

Consider the Federal Register notice announcing the August 14/15 meeting of the FDA's Risk Communications advisory committee:

"The committee will meet for presentations and discussion of the scientific basis for translating principles of risk communication into practice in situations of emerging and uncertain risk."

And this is the committee that's mandated to create clear ways to discuss risk communications (or as it's cool to say in DC "Plain English").

I think it was Albert Einstein who said something along the lines of, "If you can't explain a complicated topic in a simple way -- then you don't really understand it."  Read More & Comment...

Next Time Just Let Her Die and Don't Send A Letter

07/30/2008 02:38 AM |

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A Gaggle of Wonks. Another Step Towards Patient-Centric Care

07/29/2008 11:44 AM |

What happens when you put Mark McClellan (Chairman of the Reagan/Udall Foundation), Michael Weber (Chairman of the Center for Medicine in the Public Interest), Ralph Snyderman (of Duke reknown), Tevi Troy (Deputy Secretary of Health and Human Services), Jeff Cossman (President of the Critical Path Institute) and other leaders in progressive healthcare policy together in a room?

What happens is the meeting of the Patient-Centric Health Leadership Forum.

This new report shares the cutting edge thinking of the folks mentioned above along with other similarly talented leaders. And the key phrase is patient-centric.

The report can be found at the top of this page or here, the first item under "reports."

A worthwhile and important read.  Read More & Comment...

The Last Lecture and Comparative Effectiveness

07/29/2008 06:29 AM |

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Maggie Mahar Makes It Up As She Goes Along

07/29/2008 06:20 AM |

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Pound Foolish

07/28/2008 12:21 PM |

Experimental cures are often the last hope for dying patients in the U. K. health system. Thanks to the British government, however, many sick Britons will soon have their last hopes dashed.

Why? Pharmaceutical companies from around the world have been scaling back clinical research in the United Kingdom, largely because of government parsimony. And British citizens have paid the price.

Read more about this distressing development here:

British system discourages availability of new drugs

With health care reform in America at the top of the agenda this election season, it’s more important than ever that we be aware of the dangers of government- run health care. America should avoid Britain’s mistakes and make sure we keep the interests — and hopes — of patients first in our pursuit of reform.

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Some People Just Want to Watch the World Burn

07/27/2008 05:29 PM |

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NPR Does PR for NICE and NHS

07/25/2008 06:17 PM |

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One of the other Johns from Arizona

07/25/2008 11:28 AM |

Often considered a surrogate for Senator McCain on all matters healthcare, we interviewed Representative John Shadegg (R, AZ) to see what he had to say.

See for yourself:

Shaedegg Video Interview

And let us know what you think.  Read More & Comment...

Off his meds

07/24/2008 06:44 PM |

Per the Zyprexa show-trial, consider the remarks of US District Court Judge Jack Weinstein:

“Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.”

How do you spell “r-e-c-u-s-a-l?”

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NICE Seeks to Sell Rationing Services

07/24/2008 12:52 PM |

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Able Victor

07/24/2008 10:01 AM |

As we mourn the passing of Victor McKusick, “the father of medical genetics,” his legacy lives on in today’s healthcare headlines.

Today, as if in honor of the great man's passing, the FDA will announce an advisory for physicians to use a genetic test to screen patients before prescribing abacavir, a widely used drug for H.I.V. infection and AIDS.

(Abacavir, developed by GlaxoSmithKline, is sold under the name Ziagen. It is also a component of two combination pills — Trizivir and Epzicom.)

According to Andrew Pollack in today’s New York Times, “The recommendation for the test is part of a movement toward so-called personalized medicine, in which genetic or other tests are used to determine which drugs are best for a patient and which should be avoided.”

Here is the complete New York Times story

Let’s honor Dr. McKusick by fully funding the Reagan/Udall Foundation and advancing the agenda of the FDA’s Critical Path Initiative.   Read More & Comment...