Latest Drugwonks' Blog

Wny not extend this concept to every aspect of health care possible? Why not pay people for NOT using health care services, for staying healthy, for exercising?

Stay healthy, pay less.
Get healthy, earn money
Prevent disease, get paid.
Read article here

Shipping Policy

  • 12.10.2008
Shipping Policy

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Lest anyone forget, the indicted Democrat governor had lots of friends the last time he peddled his failed and fudged I-SaveRx program to reimport drugs from wholesalers in Canada, Ireland and other places that Blago made up on the fly....another scam:

"Blagojevich has been among a growing bipartisan group of politicians that is fighting Bush on the importation issue. He and U.S. Rep. Rahm Emanuel, D-Ill., contend that increasing drug imports will create competitive pressures that will force pharmaceutical companies to lower their prices in the United States. The two have even organized a program, so far lightly used, in which residents in Illinois and a few other states can purchase drugs through the Internet from Canada and Europe."

Canada considers plan to stop Internet, mail-order drug sales to Americans.

Source: Chicago Tribune (Chicago, IL)

Publication Date: 06-JAN-05

NHS has SURPLUS of £2billion in the bank after underspending
By JO MACFARLANE
Last updated at 2:21 AM on 08th June 2008


Surplus: Shadow Health Secretary Andrew Lansley claimed the government had failed to use taxpayers money to provide care at a time of cuts

The NHS has underspent by more than £2billion after slashing training and cutting patient care.

About two per cent of last year's total NHS budget was not spent - just two years after the NHS was £547million in debt.


Meanwhile biotech in Britain in dying....thanks to NICE


In 2007, Sir David Cooksey, one of the fathers of British biotech said that "The UK is home to the strongest medical research community in Europe, yet there is no framework for bringing innovation from university laboratories and research organisations into the business world. The presence of the drugs-rationing group the National Institute of Health and Clinical Excellence adds a layer of bureaucracy absent in Europe or the United States."

Now...
Read Here

UK biotech leaders demand government investment for its survival

Monday 8 December 2008
Simon Varcoe - Reporter

Sir Christopher Evans, head of the biotech fund manager Excalibur, and 21 other leading figures in UK biotech are calling on the UK government to make significant investment in the sector to ensure its survival.

Peter Orzsag, the CBO Director who believes innovation is the source of many of the health care systems dysfunctions should be happy.   Rationing innovation saves  money...kills innovation.    I am sure the perpetual priapism of self pronouncement against medical progress such as Merrill Goozner and Healthcare Renewal should be covulsing with joy over the demise of innovation and the surplus of dollars due to the denial of care as the result of comparative effectiveness.   Dollars in the counting house from rationing.  If only Dickens were alive today!  

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Will NICE Suffice?

  • 12.08.2008
Lots of letters in today's edition of the New York Times on NICE and the issue of cost-based vs. patient-centric care. To see them all, click here.

Here's my contribution:

To the Editor:

The National Institute for Health and Clinical Excellence in Britain is set to lift its ban on several kidney cancer drugs. The move will give patients access to lifesaving medicines that had previously been deemed “too costly” to cover under public health insurance.

This reversal is effectively an acknowledgment that the agency hasn’t worked as intended. By denying patients access to cutting-edge treatments simply because of cost, it has heartlessly put lives at risk.

Peter Pitts
New York, Dec. 3, 2008

The writer is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.

Barbara Stanwyck (the actress) said of egotism that it's a case of mistaken nonentity.  The same can be said the rampant speculation and self-promotion regarding who is going to be the next FDA commissioner.   Lots of people weighing in who don't know the full story or the full weight of the  job.  Lots of second guessing.  Only one or two  people who are willing to stand and accept the responsbility and stand by decisions regardless of what is said to attract the crowd or generate a headline. 

That's why Janet Woodcock's statement regarding Vytorin and Avandia are so courageous and on point: "People have convicted them without a trial."   But she has taken similar stands on drugs that others though should have been approved, but have not, because of lack of compelling benefit data, and on demanding that FDA have more hires, that staff actually get paid on time, that the new FDA building have a cafeteria(!).   

Drugwonks has made it clear who it thinks should NOT be FDA commissioner.  But with regard to who should FDA Commissioner, it should be someone who can emulate and admire Janet Woodcock's dedication to science-based overhaul of the agency.


According to the Wall Street Journal, HHS Secretary-Presumptive Tom Daschle wants Americans to host “holiday-season house parties to brainstorm over how best to overhaul the U.S. health-care system,” He’ll make the suggestion as part of his case for health reform in a speech to be delivered in Denver today.

How about a healthcare toga party?

(PS/ Why hasn't Daschle's nomination been made official yet?)

Stupak Attack

  • 12.05.2008

Congressman Bart Stupak does not have the courage of his convictions.

Here’s what he wrote to President-Elect Obama:

"I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA … Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for."

He’s a bully – and a coward since he didn’t back up any of his accusations with even a scintilla of evidence – and didn’t name any names, yet he’s calling for a "complete change in the FDA's leadership."

Here’s some news for Mr. Stupak – there are precisely zero political appointees (“Schedule C” employees) in any of the FDA’s five centers (drugs, biologics, food, medical devices, and veterinary medicine).  None.  And all five center directors are career public health officials. And Mr. Stupak – the 11,000 career staff at the FDA know precisely who they work for – the American public.

It is an absolute abomination that Congressman Stupak should cast such squalid aspersions on the men and women of the FDA who work long hours under tremendous pressure with little recognition at government pay to help protect and advance the public health.

Is the Honorable Mr. Stupak accusing career FDA staffers of taking bribes?  If so, let him say so.  If not, let him apologize.  

Just as the FDA dips its toes into the world of social media with via a new partnership with WebMD (details here), some pharmaceutical and medical device companies are stepping into something else -- abuse of social media.

Here's the dénouement -- social media must play by the same regulatory rules as, well, pre-social media.

After all, if the medium is the message – and the message is regulated – than the same rules apply. Specifically FDA rules, guidances – and draft guidances.  This is not rocket science and pharmaceutical and medical device companies should know this without having to be told.

Alas, that does not seem to be the case with some.  

In September, the FDA sent a letter to Shire Pharmaceuticals, asking it to pull a YouTube video for Adderall XR that the agency said overstated the hyperactivity drug's effectiveness and omitted risk information. The company said it didn't intend to post the video on the site and, upon learning of the posting in May 2007, promptly removed it.

The newest culprits in this space are YouTube videos for medical devices sold by Abbott Labs, Medtronic and Stryker. The Prescription Project (with whom we share almost no common ground) points out that these videos violate federal rules because they don't contain required warnings and disclosures.  And they’re right.

Stryker said it wouldn't comment because the issue was before the FDA. Medtronic said it is committed to adhering to FDA guidelines for direct-to-consumer advertising. The company said the video in question had been taken down. An Abbott spokesman said the company posted a link to safety and risk information next to its YouTube video, but will from now on embed safety and risk information in such videos.

Social media is the wave of the present and presents powerful new ways to both market to and educate the public. Mistakes such as these are not acceptable and will only lead to more Congressional fist pounding. The good news is that they are easy to avoid.  Just follow the rules.   Social media – indeed all media – must be used responsibly, in compliance, and for the benefit of the public health.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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