Medicaid IS The Public Option

12/17/2009 06:13 PM |

The vast majority of people who will receive what is deemed health care coverage in both House and Senate bills will be through Medicaid -- a government run program.   The consequences of this feature of "reform" will be severe and far-reaching,  creating shortages in physician care and undermining access to medical services.  This quote from a doctor in South Dakota sums up the the wonderland we will all live in in the years ahead...

“If you end up seeing patients that cost you money to see, and you have no other ability to make up for that ... then you have to decide if you’re going to continue to see more Medicaid  patients,” said Tom Huber, MD, president-elect of the SDSMA in a March 2009 interview for KELO-TV. “If taking care of more people under
the Medicaid program means my business no  longer survives, then I’m doing a disservice to all the other patients, and that’s the dilemma that  physicians are facing.

You can read all about how shoving people into Medicaid could very well be the most cynical element of health care reform...

http://www.sdsma.org/documents/MedicaidSummerStudy.final.pdf  Read More & Comment...

And speaking of healthcare reform ...

12/17/2009 08:50 AM |

London, England (CNN) -- The entire genetic codes of two common types of cancer have been cracked, according to scientists, who say the breakthrough could unlock a new era in the treatment of deadly diseases.

Scientists at the UK-based Wellcome Trust Sanger Institute catalogued the genetic maps of skin and lung cancer and have pinpointed the specific mutations within DNA that can lead to dangerous tumors.

Researchers predict these maps will offer patients a personalized treatment option that ranges from earlier detection to the types of medication used to treat cancer.

The genetic maps will also allow cancer researchers to study cells with defective DNA and produce more powerful drugs to fight the errors, according to the the study's scientists.

"The knowledge we extract over the next few years will have major implications for treatment," Peter Campbell from the Wellcome Trust Sanger Institute said.

"By identifying all the cancer genes we will be able to develop new drugs that target the specific mutated genes and work out which patients will benefit from these novel treatments."

Scientists found that the DNA code for skin cancer contained nearly 30,000 errors and lung cancer DNA contained more than 23,000.

"These are the two main cancers in the developed world for which we know the primary exposure," Mike Stratton, from the Cancer Genome Project said.

"For lung cancer, it is cigarette smoke and for malignant melanoma it is exposure to sunlight.

"With these genome sequences, we have been able to explore deep into the past of each tumor, uncovering with remarkable clarity the imprints of these environmental mutagens on DNA, which occurred years before the tumor became apparent."

The study suggests that an error occurs for every 15 cigarettes that are smoked.

Scientists as part of the International Cancer Genome Consortium in other countries around the world are completing similar studies -- the UK is looking at breast cancer, the U.S. at brain, ovary and pancreatic cancer, and Japan at the liver.

Cancer is a leading cause of death worldwide and claims more than seven million lives each year according to the World Health Organization.

  Read More & Comment...

Eshoo-ing FOBs

12/17/2009 08:21 AM |

Michael Hiltzik writes in today’s Los Angeles Times:

“The debate over healthcare reform is focused on such a small number of hot issues -- should there be a public option, Medicare buy-in, government-paid mental health counseling for Sen. Lieberman? -- that dozens of other questions are cruising under the radar.”

Well, at least we know where he’s coming from.

Hiltzik continues:

“Here's one worth a lot more attention than it has been getting: Is Congress poised to make a big payoff to biotech firms and their venture backers by hindering the entry of a new class of generic drugs into the marketplace?”

He refers to the Eshoo Amendment.  He has a lot of problems with it – most notably the fact that it gives innovator products a dozen years of exclusivity.  While it’s hard to  take anyone who refers to follow-on biologics as “generics” seriously, a few points on why Mr. Hiltzik is completely wrong about the Eshoo language.

First, the Eshoo legislation puts a priority on patient safety by requiring appropriate and stringent clinical trials and testing. This is necessary because biologic drugs are created from living organisms such as proteins and carbohydrates, and are not as simple to replicate as traditional drugs like aspirin and antihistamines.

Second, by protecting adequate data exclusivity, innovator companies will not be forced to charge more for their biologic treatments.

Third, Eshoo’s legislation rewards new biologic innovation by drug companies because it grants them a longer period of data exclusivity to continue research and development to fight other diseases.

Fourth, Eshoo’s legislation gives hope to those suffering from rare diseases or conditions. If drug companies think they will have a short time before a generic version of their product is on the market, they will only focus on the drugs for major diseases and conditions, potentially ignoring ailments that are less common, but equally as serious, to those suffering.

Follow-on biologic legislation must be about balancing patient safety and cost reduction. To ignore either one — or to unnecessarily rush creating this pathway — will only hurt those patients who depend on follow-on biologics the most.

The complete Hiltzik column can be found here:

http://www.latimes.com/business/la-fi-hiltzik17-2009dec17,0,1929214.column

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Hating Joe Lieberman for Being Jewish

12/16/2009 10:37 PM |

His sin?  Not supporting the public "option" or a Medicare buy in..

Here is a partial list of (self) haters who go after Joe because he is Jewish...

One.

Two.

Three.

Four.

  Read More & Comment...

Sweet Sanity

12/16/2009 07:56 AM |

Senator Dorgan’s amendment on drug importation goes down with a vote of 51-48 in favor. (60 votes were needed to prevail under a special rule.)

Senator Lautenberg’s amendment (importation with Secretarial certification) also went down (56-43).  According to the AP, “His proposal permits drug imports but adds a requirement that the U.S. government certify that the imports will be safe — a guarantee that Democrats and Republicans agree would be impossible to make.”

Sweet sanity.

Can we debate healthcare reform now?

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Hanukkah Melt Down on the Far Left

12/15/2009 11:20 PM |

In every generation....

http://spectator.org/archives/2009/12/14/hanukkahs-scrooge
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No Show on the Snyderman Show

12/15/2009 06:42 PM |

Goldberg News News Goldberg News, latest news about Goldberg News.

VIDEO: WHO IS SPYING ON YOUR PRESCRIPTIONS?
Dec. 15: Pharmaceutical companies are increasingly peeking at doctor's prescription pads, raising many concerns. Dr. Nancy Snyderman talks with consumer health advocate Marcia Hams and Robert Goldberg, a pharmaceutical industry advocate. (Other)
12/15/2009 23:20, msnbc



I didn't get a chance to be in this segment...I was in MSNBC's Green Room waiting to be led into the studio and saw the segment running.  A producer (?) rushed in and told me to run into another studio where I was miked for the segment.  Dr. Snyderman cut to commercial with a teaser about how kids who have a low sexual IQ are endangering themselves... (I was wondering if I had to shift gears and weigh in...)  In any event, another MSNBC person came and told me I missed the segment, thanks but no thanks..

Anyways,  what I would have said if had the chance.

First,  as Peter noted previously,  patient level data should not be used to market directly to patients.. That said, why is Ms. Hams organization proudly linked to a website from an insurance company that used patient prescribing data to bribe doctors to switch patients to generic drugs without telling them... 

http://www.crainsdetroit.com/article/20090301/SUB01/902269981

Moreover, data mining and contacting patients is critical to promoting compliance and personalized medicine. Lack of compliance with prescription regimens is a source of increased illness, mortality and medical costs.  It is a serious public health problem   The generic uber alles approach pushed by The Prescription Project likely adds to the problem since studies show that tiered formularies and generic mandates tied to higher co-pays with other drugs are associated with increased illness.
 
http://www.managedcaremag.com/archives/0408/0408.drugtier.html

  But even allowing drug companies to use data that patients and doctors voluntarily give is grounds for legal and political attacks.  No surprise.   Ms. Hams organization is lawsuit driven.  It's Prescription Access Litigation Project generates revenue by suing drug companies and has partnered with tort law firms whose senior partners are now in the slammer for sleazy and illegal practices.  Talk about putting profit ahead of patient wellbeing..

http://www.prescriptionaccess.org/press/pressreleases?id=0010

money.cnn.com/magazines/fortune/fortune_archive/2006/11/13/8393127/index.htm


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Importation conundrum

12/15/2009 09:35 AM |

Today every member of the Senate Democratic Caucus is headed to the White House for yet another pep talk from President Obama in a last-ditch effort to secure passage of some kind of health care bill.

In the last couple days Senator’s Dorgan drug importation amendment has proven a major stumbling block to passing a health care bill.

Whether or not Senator Dorgan is amenable to compromise remains to be seen. This puts President Obama in an incredibly difficult spot. On one hand, the more liberal members of his party are absolutely determined to squeeze more out of those evil pharmaceutical companies. But PhRMA struck a deal early on in this process with the Obama administration and has heavily assisted in promoting the president’s health care agenda.

Will President Obama risk creating another obstacle to passing a bill by challenging Dorgan, or does he throw PhRMA under the bus?

As for Dorgan, if he is truly interested in cost control, then why not focus his efforts on the genuine waste in the system (particularly in Medicare and Medicaid) instead of attacking an innovative industry?

Could it be his only reason for pushing this perpetually nonsensical proposal is that the pharmaceutical industry makes for a politically convenient target that distracts from the really asinine aspects of the Senate bill?

Senator Dorgan needs to ask himself three simple questions:

1. Do prescriptions drugs save the health care system money in the long-term by rendering surgeries and lengthy hospital stays unnecessary?

2. How would Canada respond to US legislation allowing for importation of drugs?

3. Is importing drugs from Canada safe?

On the issue of safety, The Hill reports on FDA Commissioner Margaret Hamburg’s letter to Senator Sam Brownback:

The Dorgan amendment “as currently written, the resulting structure would be logistically challenging to implement and resource intensive. In addition, there are significant safety concerns,” Hamburg wrote in a letter to Sen. Sam Brownback (R-Kan.), related to preventing counterfeit or mislabeled medicines from being sold in U.S. pharmacies.

“We commend the sponsors for their efforts to include numerous protective measures in the bill that address the inherent risks of importing foreign products and other safety concerns relating to the distribution system for drugs within the U.S.,” Hamburg wrote, while emphasizing the legislation does not achieve those objectives.

What was Dorgan's response to the FDA's statement?

He called it "completely bogus."

Wow, now there’s a measured response.

If Dorgan loses re-election next year, maybe he can look into a future position as FDA Commissioner. He apparently has the credentials for the job.

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Women and Health Care reform

12/15/2009 09:30 AM |

Prior to the passage of the House health care bill, Speaker Nancy Pelosi said the following on the House floor:

“For all Americans, this legislation makes a big difference: no discrimination for pre-existing medical conditions, no dropped coverage if you are sick, no co-pays for preventive care. There is a cap on what you pay in but there is no cap on the benefits that you receive. It works for seniors closing the donut hole, offering better primary care, and strengthening Medicare for years to come. It works for women preventing insurance companies from charging women more than men for the same coverage. No longer will being a woman be a pre-existing medical condition.”

As I pointed out back in September, it is not the same coverage. Men and women share different medical risks. Insurance premiums are based on those risks. Just as men generally pay higher premiums for both auto and life insurance, women generally pay higher health insurance premiums. That is price discrimination based on financial risks.

But the point of this post is not to rehash that issue.

CMPI Vice-President Bob Goldberg posed the following question in his recent piece in the American Spectator:

Is health care reform designed to discriminate against women?

It’s a question worth asking. Bob cited the cosmetic surgery tax in the Senate health care bill as proof of the legislative assault on women.

Planned Parenthood protested Senator Ben Nelson’s abortion amendment holding signs that read, "Listen up senators: Women's health is not negotiable."

However, Planned Parenthood and other women’s groups are nowhere to be found on the issue of a cosmetic surgery tax. Something tells me if a tax was proposed on abortion procedures, they’d be out in full force speaking on behalf of women’s health.

A cosmetic surgery tax tinkers with one of the more productive sectors of the overall US health care system – more productive in the sense that there is a 93 percent satisfaction rate among patients who undergo cosmetic medical procedures. Moreover, inasmuch as patients typically pay out of pocket for many cosmetic procedures the sector has seen downward pressure on prices on account of the highly competitive market.

The primary problem with this tax is the government fails to make any distinction between a truly “cosmetic” procedure and a procedure for legitimate medical reasons. Senator Tom Coburn (R-OK) recently warned about this shortcoming saying, “They're going to tax having your breast rebuilt after your breast is taken off because it is elective plastic surgery. We're in trouble as a nation because we've taken our eye off the ball.”

The failure to distinguish between cosmetic procedures for medically elective and medically necessary reasons aside, the tax is still a terrible idea. Perhaps even more troubling, a tax on cosmetic procedures would be heavily borne by women. Indeed, 86 percent of cosmetic surgery patients are female. Contrary to popular opinion, this tax would not fall on the wealthy. About 70 percent of these patients earn less than $60,000 a year. Cosmetic surgeon Stephen Greenberg notes, “The misconception about people having cosmetic-surgery procedures is that they're wealthy. But it's . . . the average person who wants to feel better about themselves.”

Another significant shortcoming of this proposal is the belief that a tax will produce the revenues anticipated. It is important to recognize that New Jersey is the only state that taxes cosmetic surgeries and that tax has produced nearly 60 percent less revenues than originally projected. If New Jersey’s experience is any indication, the government will wind up investing more money for each dollar collected.

So does this tax discriminate against women? You make the call.

  Read More & Comment...

Kohl Comfort

12/15/2009 08:06 AM |

Senator Herb Kohl’s proposal to ban the collection of doctors' prescription records for marketing purposes is unlikely to be included as part of the Senate's overall health reform bill. A Kohl staffer said the change was not likely to come up for a vote or be included as part of a package of changes to be offered later by Senate Majority Leader Harry Reid.

While Kohl's ban is unlikely now, supporters will continue to push for the measure in other ways, the senator's staff member said. "We hope it happens at some point."

I don’t agree.

While physician-prescribing data shouldn't be available for marketing purposes, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.

When FDA-directed safety warnings are issued, they're communicated via "Dear Doctor" letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.

Further, FDA-mandated risk management plans - developed for physicians who prescribe higher-risk therapies - are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.

According to the American Medical Association (AMA), "Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others."

The AMA has a web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing-data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.

The safeguards offered by the AMA's program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered legislation on either the state or federal level now or in the future.

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Rolling Snake Eyes on Importation

12/14/2009 08:23 AM |

Bouquets to Senator Bob Menendez (D. NJ) who had the following to say about legalizing drug importation, “Health-care reform and lowering costs does not mean we should roll the dice with the health and safety of the American people.”

And Brickbats to Senator Byron Dorgan (D, ND), who said he will object to any amendments to the Senates healthcare reform bill until objections are lifted to a vote on his importation proposal.

“I fully expect to get a vote and I expect we will win,” Dorgan said.

But at what cost to drug safety and the public health?

According to the FDA -- in a December 8th letter to Senator Sam Brownback (R, KS) -- the Dorgan scheme doesn’t address “significant safety issues related to confusion in distribution and labeling” of foreign and domestic drugs.

Dorgan said the FDA letter overlooks “dramatic new safety provisions” in the legislation and said political concerns were prevailing in the decision to delay.

Except there aren’t any new dramatic new safety provisions.

“There are people walking on egg shells” out of concern that the drug industry will oppose the bill, Dorgan said.

Not so.  The concern is over drug safety. And appropriately so.

  Read More & Comment...

The Post Obamacare World

12/13/2009 04:22 PM |

Someone will have to be clean up the mess... the private sector to the rescue...

http://online.wsj.com/article/SB10001424052748704240504574586260904799386.html?mod=rss_Today%27s_Most_Popular  Read More & Comment...

Heavy Bleeding

12/11/2009 09:25 AM |

Inside-the-Beltway chatter has it that some members of the Republican caucus are getting ready to support Senator Dorgan’s drug importation amendment in the misguided belief that it will serve as a healthcare reform “poison pill.”

Not.

The theory is that if the Dorgan Organ passes, then Big Pharma will throw its weight against the legislation.

Not.

This strategy is ill-considered for a multitude of reasons. Let me mention three:

(1) Volume.  Big Pharma has more immediate big fish to fry, most notably protection of the Non-Interference Clause and a future with many more Medicare-eligible seniors having their on-patent prescription medicines paid for via Part D.  And filling the doughnut hole (another part of “the deal”) is a crucial part of this strategy.  Immediate (and likely permanent) increases in volume trumps the many negatives of drug importation.  Short sighted?  Certainly.  But these are public companies with patent expiry issues, reimbursement worries and questionable pipelines. Big Pharma – while against drug importation – won’t go to the mat at this stage in the process.

(2) Price Controls. Drug importation is a big shove down the slippery slope towards pharmaceutical price controls.  In fact, it is the importation of foreign price controls at worst and reference pricing at, well, at worst.  And don’t kid yourself, that’s the real reason why folks like Rahm Emmanuel (who promulgated similar legislation when he was in Congress) and Bernie Sanders (the Senator from Ben & Jerry’s) support this idea.  Every government study shows that importation schemes don’t save us money.  So, why pursue this silly soundbite strategy if not for more nefarious purposes? Voting “for” drug importation to kill flawed healthcare reform legislation is like having a hysterectomy to control menorrhagia.  

(3) Safety.  Most importantly – MOST IMPORTANTLY – is the fact – THE FACT – that drug importation makes our prescription medicines supply less safe – LESS SAFE.  And that is just not acceptable.  Not under any circumstances.

A vote for drug importation minus Secretarial Certification is a very big mistake – regardless of motivation.

  Read More & Comment...

Government-run health care = Heaven on earth

12/10/2009 09:29 AM |

Matt Miller at Daily Beast is all giddy over the Senate deal on the public option.

He explains his giddiness as follows:

“…the emerging bills will deliver what most on the left would have considered a miracle a few years back. Nearly $900 billion will be spent over ten years to achieve near-universal coverage. Insurance companies will never again deny people coverage based on pre-existing conditions. New limits on out-of-pocket costs as a percent of income will mean that no American will ever go bankrupt from medical costs again. And, thanks to the Senate’s Tuesday deal, Americans aged 55 to 64 who lose coverage (and can't find affordable new coverage on their own) would be able to buy into Medicare, with help via new subsidies—an idea the left has craved since President Clinton first pushed for it in the late 1990s.”

Miller continues: “Make no mistake: these changes would bring America at long last into the community of civilized wealthy nations.”

Ah, yes, socialized medicine is upon us.

In the words of Hillary Clinton: “The sky will open, the light will come down, celestial choirs will be singing and everyone will know we should do the right thing and the world will be perfect.”

One hates to burst Mr. Miller’s bubble of euphoria, but his comments bear no resemblance to the realities of the health care situation. Government-run health systems have been unmitigated disasters around the world.

Let’s take Canada for instance, our neighbor to the north.

Why are so many Canadians coming to a country with an uncivilized medical system every year? Especially when the Canadians are light years ahead of us as a civilized wealthy nation?

Mr. Miller bemoans medical bankruptcies, all the while pretending as if people in those other civilized wealthy nations of which he speaks do not take out loans and declare bankruptcy on account of medical bills.

Newsflash: People do take out private loans, mortgage their homes, declare bankruptcy, and even pull their own teeth because government denies them medical treatment in these countries.

Senate Majority Leader Harry Reid recently cited questionable medical bankruptcy numbers on the Senate floor. But as Keith Hennessey notes, even if the numbers are accurate that’s no reason to justify a massive transformation of the existing health care system.

Ontario’s Hamilton Spectator ran a series of pieces last month detailing the problems with the health system up north.

Case in point: They tell the story of a teenager named Brandon Taylor who had to contend with the pain of a herniated disc.

The Spectator reports:

The now 22-year-old Hamilton student and his father, Stuart, were told open-back surgery at Brandon's age could be dangerous.

The wait to see a specialist who could help decide treatment was up to a year, they were told. The best the Ontario health system could offer was prescription painkillers.

In August 2007, Stuart Taylor packed up his son and agreed to pay $28,000 in Florida for minimally invasive laser microsurgery. The treatment worked for Brandon, now a fourth-year engineering student at McMaster University.

Brandon’s father remortgaged his house to pay for the $28,000 surgery.

Get this, though – the use of lasers is considered “experimental” in Ontario.

We’re talking about procedures that are relatively routine here in the United States, but out of reach for so many Canadians.

So after the drama of this whole episode, what is the Taylor family doing now?

They are trying to secure reimbursement for the out-of-pocket expenses.

As this article explains, not only do these Canadians have to spend money out pocket to come to the United States for quality medical care, but they have to jump through bureaucratic hoops in a mostly vain attempt to get expenses reimbursed. Some people can afford an attorney to represent them, but many cannot.

Brandon’s father believes the process is an uphill battle that is draining his family emotionally and physically and will end only in loss of their case. He said, "Mentally, I'd love to abandon it because it's dragging me down ... but I can't imagine (doing that) now after all this work."

This is the sort of civilized health care system you can look forward to in Matt Miller’s brave new world.


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Health Care reform…the Hoosier way

12/10/2009 09:20 AM |

CMPI Vice-President Bob Goldberg has an excellent piece on Governor Mitch Daniels’ solid health care reforms in Indiana.

Though, of particular note is Daniels position on the health care reform package underway in the US Senate, specifically with regard to the expansion of Medicaid.

Here is an excerpt from Bob’s piece:

Taking the lead on health care is something Daniels is doing more frequently these days. His off-the-cuff critique of the House health care bill at last week's Republican Governors Association meeting was withering: " ['Deficit neutral'] is a fraudulent description of the cost of the bill. It counts ten years of taxes and only 5-6 years of spending. On this Medicaid mandate [for the states] . . . we all know a sucker play when we see one. The states' share will be relatively small initially. This is what people told subprime borrowers about their adjustable rate mortgages. We know the balloon payment will come outside the scoring window. The taxes on our states will be much, much higher. . . . The worst effect will be the depressing effect on economic growth."

Bob recently interviewed Governor Daniels on the Medicaid issue and other reform ideas at his Indiana office.

To watch this video interview, click here:

Governor Mitch Daniels of Indiana on Health Care Reform from CMPI on Vimeo.

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Worst Appointments, Best Appointments

12/10/2009 09:11 AM |

Good article in this month’s Nature Biotechnology on some of FDA Commissioner Peggy Hamburg’s recent appointments.

The guy getting the most attention (not surprisingly) is Peter Lurie, late of Public Citizen.

I am quoted as follows:

Lurie has earned the reputation of being an industry antagonist.  When you’re at the FDA, you need to look at each individual circumstance agnostically. If you go into the job as an advocate, you are doing the agency and public health a disservice.

Not meant as a dis to Peter (a nice guy). More of a warning shot across the bow that people are watching.

Nature Biotechnology, comments on the broader range of appointments (many of them stellar – specifically that of John Taylor):

The number of outside critics brought into the agency is a signal that Hamburg is not so much cleaning house as building a team with the most interested and motivated people she can find. According to Frank Torti, formerFDA chief scientist and principal deputy commissioner, who served as acting commissioner after Andrew von Eschenbach stepped down, “I think it’s important and wise to actually engage people from a variety of viewpoints in thinking about the FDA, so that reaching out to advocacy groups is a smart and necessary piece of reflecting different viewpoints. It makes some sense to me.”

Me too.  Mostly.

The complete Nature Biotechnology article can be found here:

http://www.nature.com/nbt/journal/v27/n12/pdf/nbt1209-1067.pdf

 

 

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FT for Two

12/09/2009 11:13 AM |

Another fine piece of straight-shooting journalism from the FT. The article, “Medical Marvals” (by Andrew Jack and Clive Cookson) looks at the challenges and opportunities of the FDA under Commissioner Peggy Hamburg.

It begins with a symbol:

“Margaret Hamburg had scarcely begun her work as commissioner of the US Food and Drug -Administration over the summer when she travelled to meet her counterparts at the European Medicines Agency in London. The trip symbolised a strengthening appetite for international cooperation between the FDA and the EMEA, at a time when the globalisation of medical products has highlighted continuing regulatory differences and made the demands for co-operation greater than ever before. It also reflected a fresh sense of self-confidence and willingness to communicate externally at the US agency, after several years of unstable leadership and internal demoralisation in the face of criticism from politicians, lawyers, companies and medical researchers alike.”

And ends with a reality check:

“Pitts argues the agency still faces enormous challenges in updating its computer systems and adapting to an era of biological medicines. As for international convergence, he adds it too has limits. Different nations need different bodies to be held accountable, he says.”

And, in between, much useful information and conversation.

The complete article can be found here:

http://www.ft.com/cms/s/0/b8e56a28-e32e-11de-b965-00144feab49a.html

And speaking of the FDA and Peggy Hamburg, the Hill reports that the FDA said "a proposal to enable the importation of cheaper prescription drugs could endanger the US medicine supply and would be difficult to implement." According to The Hill, "These criticisms from Margaret Hamburg, President Barack Obama's FDA commissioner, could prove damaging to an effort by a broad coalition to enact the longstanding goal of easing consumers' access to prescription drugs from countries such as Canada, where the prices are generally lower than in the United States." Sen. Byron Dorgan (D-ND) "introduced his amendment to the healthcare bill on Tuesday with the support of 19 other senators, including four Republicans, setting up a vote Wednesday."

And the Associated Press adds that Senator Dorgan replied to the FDA concerns, saying, "I'm going to go home kind of upset about this letter today from the FDA, which is in my judgment completely bogus." In its letter, the FDA "said that while Dorgan's plan seeks to address safety risks, concerns remain about copycat versions of high-technology biological drugs and about confusion surrounding the distribution of foreign products."

Senator, don’t go home mad. Just go home.

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Healthcare Reform in the Heartland

12/08/2009 12:29 PM |

My article in The Weekly Standard on the Mitch Daniels approach to health care reform:


http://theweeklystandard.com/Content/Public/Articles/000/000/017/277bjeer.asp?pg=2
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"Hole" Nelson

12/07/2009 08:49 AM |

Senator Bill Nelson (D, FL) is threatening to vote “nay” unless the Senate busts President Obama’s $80 billion Big Pharma “deal.” Senator Nelson wants deeper Medicare/Medicaid discounts and the complete annihilation of the infamous doughnut hole.

Maybe we should start calling him “Hole” Nelson.

For a good report on the “deal” as well as how other aspects of healthcare reform legislation impact Big Pharma, see here:

http://www.mmm-online.com/outlook-2010-a-new-dawn/article/158861/

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Purses. Spoiled Again.

12/04/2009 04:00 PM |

What do you call conflict of interest when it's the government writing the check?  Healthcare reform legislation.

The Senate’s Patient Protection and Affordable Care Act would establish a new, independent, nonprofit, "Patient Centered Outcomes Research Institute" to contract with the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH), and others to produce comparative effectiveness research (CER).

One section of the Senate bill imposes harsh penalties for the publication of certain types of research. While the bill allows for the publication of research conducted under contract to the Patient Centered Outcomes Research Institute in a peer-reviewed journal or other publications, the draft legislation also allow this new Institute, at its own discretion, to withhold funding from any institution whose researchers publish results that are not "within the bounds of and entirely consistent with the evidence."

"(iv) REQUIREMENTS FOR PUBLICATION OF RESEARCH- Any research published under clause (ii)(IV) shall be within the bounds of and entirely consistent with the evidence and findings produced under the contract with the Institute under this subparagraph. If the Institute determines that those requirements are not met, the Institute shall not enter into another contract with the agency, instrumentality, or entity which managed or conducted such research for a period determined appropriate by the Institute (but not less than 5 years)."

Such language to restrict scientific freedom is unprecedented and likely unconstitutional.

Should we really be legislating science via threat of purse strings?

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