Clement, See.

01/07/2008 01:20 PM |

U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.

Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted” the law by saying the FDA’s approval of a drug label is only a “first step.” He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.

Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.”

The Solicitor General’s full opinion can be viewed at

http://www.usdoj.gov/osg/briefs/2007/2pet/6invit/2006-1249.pet.ami.inv.pdf

Clement also suggests that the Supremes hold the petition for writ of certiorari until the court decides two other preemption cases, Riegel v. Medtronic and Warner-Lambert v. Kent. According to the Solicitor General, these cases "may shed significant light on the question presented on this case."  Read More & Comment...

Emily Litella and DTC User Fees

01/07/2008 12:42 PM |

Doing its best Emily Litella impersonation, Congress has increased the amount of federal dollars available to fund FDA review of DTC ads -- rather than go with the previous (and legislated) idea for user fees designed to speed up the review process.

That's right -- "Never mind."

According a House staffer (as told to the Pink Sheet), this action "reflects House members' concern that user fees give the impression drug makers are buying FDA approval."

Well that impression needs to be changed and there's no time like the present. User fees don't buy anything except review. Nothing else. And, when it comes to DTC ads, review isn't even required by law (although it is by the PhRMA Marketing Code).

Any one who says the FDA is "in industry's pocket" is entirely ignorant of what really happens. Unfortunately, that group seems to contain a lot of our elected representatives -- including some who are running for President.  Read More & Comment...

Captains Courageous

01/07/2008 07:27 AM |

During Saturday night’s Republican debate, Senator McCain continued his benighted attack on the pharmaceutical industry – the usual half-truth talking points – and then something really unusual happened – another candidate decided that it was time for a dose of reality. Governor Romney said, “Don’t make the pharmaceutical companies into the big bad guys.”

Senator McCain thinks they are. He should talk to patients rather than listening to pollsters.

Looking at the world – and particularly the world of health care – through a “good guy/bad guy” lens is simplistic, wrong, and deleterious to real reform. But it does play well in the media. Senator John "Every Man a King" Edwards is trying the same thing. Some call it “the politics of hate.” And the fact that Michael Moore has decided endorse Edwards is an interesting addition to the divisiveness some candidates are adopting out of desperation.

Joining Governor Romney in the courageous camp of sanity is Senator Obama, who recently told a group of citizens that health care reform will not be easy and that anyone who says there’s a simple solution doesn’t know what they’re talking about.

Romney isn’t playing the easy and risk-free “blame Big Pharma” gambit and Obama isn’t opting for simple solutions -- such as drug importation (once again being embraced by both McCain and Edwards).

You mean real reform is going to be hard? That’s the truth – but will it sell?  Read More & Comment...

HillaryCare in the Cornfields

01/04/2008 11:00 AM |

Everyone is coming out with snap judgments on what caused Hillary to crash and burn in Iowa. Here's my take: her effort to paint herself as the Mother Courage of Universal Healthcare is falling flat. The more she talks about it and her ability to deliver, the less people seem to trust her and her leadership.

Senator Clinton claims she will make health care her defining issue in New Hampshire. Is that a good thing? We shall see.  Read More & Comment...

Viral Marketing

01/04/2008 09:57 AM |

FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample

The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.

The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.

The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, specific beads, or microspheres, bind to the amplified viral genetic material. The beads are then sorted so that the specific virus can be identified.

The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample.

"Nucleic acid tests such as the xTAG Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

"This speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week," said Schultz. "And, because this multiplex viral panel tests for 12 viruses at once, it uses less of a patient's test specimen."

The full FDA announcement can be found at

http://www.fda.gov

TAG -- you're it.  Read More & Comment...

Cardiac Care in Aisle Six

01/03/2008 01:18 PM |

Where are you likely to receive better cardiac care, your hospital's ER or the men's department at Nordstrom's?

A recent study from the NEJM suggests that the refusal of hospitals -- perhaps out of litigation fear -- to allow the use of automatic defibrillators -- might be a reason thousands die of heart attacks who would otherwise still be alive.

Automatic defibrillators that have come into use in public places like airports and casinos during the last decade or so are meant to be used by laymen: trained employees or even bystanders. Connected to the chest of someone who has collapsed, the machine senses electrical activity in the heart and delivers a shock only if it is needed. These devices are designed to be essentially foolproof, making it impossible to harm someone by firing off an unnecessary shock. But so far they have not been used much in the care of hospitalized patients.

Dr. Saxon said the automatic defibrillators should be used more, along with the type of heart monitoring now given mostly to cardiac patients. Not everyone needs such monitoring, she said, but it may be in order for those who are very ill with kidney problems, diabetes or pneumonia, even if they have no history of heart problems. Their information would be transmitted to a computer network that would send out an alert if needed. In addition, she said, automatic defibrillators could be installed in every hospital room.

“You can get them for $500 on eBay,” she said. “It wouldn’t even take a nurse. You could train the cafeteria workers if you wanted to.”

Speaking on her cellphone, Dr. Saxon said, “You’re better off having your arrest at Nordstrom, where I’m standing right now, because there are 15 people around me.”

What's the hold up? My guess is fear of lawsuits. It would only take one idiot represented by John Edwards to sue a hospital for being shocked improperly by a hospital aide instead of the chief of cardiology for that nobel experiment to end.

The Precautionary Principle is killing common sense in health care. And people.

http://www.nytimes.com/2008/01/03/health/research/03heart.html?_r=2&ref=us&oref=slogin&oref=slogin  Read More & Comment...

And don't even ask about the price of haircuts

01/03/2008 07:01 AM |

A few years back, at a Senate hearing on DTC issues, Senator Debbie Stabenow (D, MI) asked an FDA official, "Why do drug companies only advertise new drugs?" My colleague's sage and savvy reply to the Senator from Michigan, "Senator, for the same reason that Detroit only advertises new cars."

Okay folks, once again into the abyss ...

Does John Edwards know more than your doctor?

These are two questions that ought to be posed to the Democratic candidate for president — who has been banging the kettle drums on the campaign trail lately demanding that laws be passed limiting what information about new drugs and treatments may fall before your eyes.

He wants to ban — or at least, heavily regulate and limit — the way that medicines can be advertised.

Instead of commercials that let people know of the existence of a newly developed drug or treatment, only doctors would be allowed to convey that information for at least two full years.

After that point, if elected, Edwards might permit some word to get out.

Maybe.

Here's the rest of the story ...

http://article.nationalreview.com/?q=ZWVmZDQ5ZTRhMGUxMDc4YTA5Y2JmNTIxYTU2Zjk4Yjk=

Cost of a shave and a haircut? Why two bits of course.  Read More & Comment...

Thanks Son

01/02/2008 04:11 PM |

Previously uninsured adults who received Medicare coverage reported improvements in health, especially those with cardiovascular disease or diabetes, according to a study in the JAMA.

Uninsured near-elderly adults, particularly those with cardiovascular disease or diabetes, experience worse health outcomes and use more health services as Medicare beneficiaries after age 65 years than insured near-elderly adults. Because chronic diseases are prevalent and insurance coverage is often unaffordable for older uninsured adults, the impact of near-universal Medicare coverage at age 65 years on the health of previously uninsured adults may be substantial, according to researchers at Brigham and Women’s Hospital and Harvard Medical School in Boston.

The researchers conclude that providing earlier health insurance coverage for uninsured adults, particularly those with cardiovascular disease or diabetes, may have considerable social and economic value for the United States by improving health outcomes.  Read More & Comment...

Thanks Mom

01/02/2008 03:06 PM |

My mother-in-law hates George W. Bush. That doesn't make her special -- but it has made her impossible to talk to about Part D. She thinks it's "Bush's thing" and has refused to even consider signing up for coverage.

Over the holidays, as she was complaining about her prescription medicine expenses, I went to the well one more time and advised her to check into signing up for Medicare drug coverage.

And you know what? She did.

She may still hate the President, but she sure loves her Part D.

Oh yes -- she lives in California.  Read More & Comment...

Weapon of Choice

01/02/2008 12:30 PM |

What do Jamie-Lynn Spears and Steve Nissen have in common? While only one looks good with a partially exposed tummy, both are dubious sources of advice in their chosen fields of expertise. At least Jamie-Lynne has the good sense not to move forward with her book about parenting -- while Steve Nissen will continue to find products to make people afraid about using meta-analysis as his weapon of choice.


http://www.chicagotribune.com/entertainment/chi-lynn-spears,1,3749621.story  Read More & Comment...

Rage Against the Machine

01/02/2008 08:18 AM |

Here's a house editorial from today's edition of the Wall Street Journal.

Stopping Medicine's Machines

The Vioxx panic seems to have subsided, but the same kind of alarmism is beginning to wash over health-care fields other than pharmaceuticals. The most recent is medical technology. Now Congress is ready to intervene, so let's try to separate good sense from exaggeration.

On the front-burner for Congressional action is Medtronic, a major medical-device maker, and the controversy surrounding a component of its heart defibrillators. Surgically implanted near the shoulder, these devices treat cardiac arrest by electrically shocking the heart back into regular rhythm. In October, in the face of escalating criticism over safety concerns, Medtronic voluntarily withdrew from the market a type of the complex wires -- called leads -- that connect a defibrillator to the heart muscle and tell it when to deliver therapy.

These Sprint Fidelis leads have a smaller diameter than most others available. Cardiologists have been calling for narrower models because they are easier to thread through the veins during surgery. Once implanted, they are less likely to lead to blood clots or obstructions, or distort heart valves.

While all leads break or "fracture," some evidence began to emerge this year that the Fidelis line, which was made available in the U.S. in 2004 and rapidly adopted, was more prone to early malfunction compared to older alternatives. A fracture can cause painful misfires, or a failure to deliver effective shocks to a dying patient.

Medtronic at first maintained the data weren't conclusive. After further internal studies and advice from its outside panel of heart doctors, it pulled the product. About 268,000 people have the implants world-wide; fractures may have contributed to five deaths. According to the company's composite estimates, 97.7% of the leads will still operate properly after 30 months in the body. The rate for Medtronic's older lead is 99.1%, a difference that isn't statistically meaningful but will be if trends remain constant.

Medtronic CEO Bill Hawkins told us that pulling Fidelis was ultimately "a judgment call." No doubt the medical side of the ledger is vastly complex. Researchers only have a limited understanding of why the leads may be less reliable. Because they were thinner, they may be more vulnerable to stress. Failures may be due to a surgeon's implant technique, or simply due to complications in patients with chronic medical conditions.

But Medtronic's withdrawal may also have been driven by legal and political calculations. Post-Vioxx, companies are under pressure to get out in front of even modest health risks. All therapies carry some risk, so these withdrawals strip choices from patients and their doctors. Mr. Hawkins notes that "society's tolerance for any risks associated with medical technology is nearing zero." The trial bar is a main offender. The first lawsuits against Medtronic were filed literally the morning after the withdrawal announcement, with many to come.

Politically, it's one thing to raise legitimate safety concerns, quite another to turn them into a pretext for longstanding agendas. Republican Senator Chuck Grassley, for instance, is targeting the device makers' consulting agreements with physicians. The implication, as with his campaign against Big Pharma, is that "kickbacks" lead to inferior products and buy "a doctor's allegiance to a particular product line." With Medtronic as Exhibit A, Mr. Grassley is pushing legislation to require regular public disclosure of the terms of all financial relationships.

The device industry says it's fine with transparency -- and who isn't? Well, doctors. Publishing such information without protections, when liability insurance costs are already through the ceiling, would do little more than create a registry of the deepest pockets for trial lawyer browsing.

The collaborations that consulting fees underpin drive innovation. Unlike new drugs, devices aren't "discovered"; they're engineered to fill specific medical needs, which requires the expertise of practicing clinicians. We're going to see a lot fewer advances in technology like defibrillators -- to say nothing of stents, artificial knees and hips, cochlear implants, deep-brain stimulators and so forth -- if doctors can't be fairly compensated for R&D participation.

Other innovation disincentives are provided by Henry Waxman, chairman of the never-sleeping House Committee on Oversight and Government Reform. He's kicked off an investigation into "what is apparently a serious shortcoming" in the FDA's device-approval process, and legislation to make it even more restrictive can't be far behind.

Devices undergo extensive laboratory "bench tests" to simulate how they'll behave under the stresses of the human body. Requiring premarket clinical trials wouldn't even detect the rare or long-term problems like the one that brought down Fidelis, and refinements of existing designs don't need square-one scrutiny. Postmarket surveillance, of the kind Medtronic and other makers conduct with their products, is a better way to monitor safety.

As with so many other medical scandals, the real danger to public health is overreaction to medical risk. Several cardiologists we spoke with (some affiliated with Medtronic) offered anecdotal evidence of high-risk patients refusing care due to the "anxiety-ridden environment," as one electrophysiologist called it. Not having a device is far worse for them than the possibility of malfunction. It might be fatal. That might not be the intent of the politicians and trial lawyers, but it is a consequence of their opportunism.  Read More & Comment...

A New Take on the Retail Health Clinic Model

01/01/2008 12:52 PM |

"VANCOUVER, Wash. -- A McDonald's employee in Vancouver is a new mom after a fast delivery at the fast-food restaurant.
Danielle Miller, 16, was working at the McDonald's on Gher Road and state Route 500 on Dec. 21 when she suddenly felt ill and ran to the bathroom, reported television station KPTV in Portland, Ore.
A friend and co-worker of Miller's followed her into the restroom and asked her if she was pregnant. Miller said no. But moments later, with the assistance of a 911 dispatcher, the friend helped Miller deliver her baby in the McDonald's restroom."

Gives a new meaning to "Do you want fries with that?"


http://www.wesh.com/family/14953330/detail.html  Read More & Comment...

The Perfect New Year's Party Favor for the Pro-Importation Crowd

12/31/2007 11:00 AM |

Here's the gift that will keep on giving...

From the LA Times round up of the year's top ten scams...

"Natural" Viagra turned out to be not so natural in some cases.

Some over-the-counter supplements, with names as unsubtle as 4Everon, claimed to remedy erectile dysfunction as effectively as the prescription drug.

The Food and Drug Administration found that they indeed did their job well. But that was because the active ingredient in the concoctions was the same as in real Viagra.

The scam could have serious consequences because the "supplements" posed health problems if mixed with drugs taken for diabetes and other conditions.

The FDA forced 4Everon off the market."

As for names...I still like the Chinese rip-off of Viagra name...Big Brother

http://www.latimes.com/business/la-fi-consumer16dec16,1,2647940.story?coll=la-headlines-business  Read More & Comment...

Old Hickory

12/31/2007 07:43 AM |

On the Presidential election and drug importation as a "hickory stick" to beat the pharmaceutical industry.

Download file

The article's conclusion says it all:

"The facts are not important. This is all about rhetoric. The facts against drug importation as sound health care policy are enormous. The argument for drug importation are political and rhetorical."  Read More & Comment...

Remember the Maine (verdict)

12/28/2007 12:33 PM |

From the pages of the Boston Globe …

Judge shoots down Maine law curbing access to prescription data

BANGOR, Maine—Relying heavily on a ruling in New Hampshire, a federal judge has overturned a new state law that restricts access by medical data companies to doctors' prescription information.

U.S. District Judge John Woodcock concluded that the law, which was scheduled to take effect Jan. 1, would prohibit "the transfer of truthful commercial information" and "violate the free speech guarantee of the First Amendment."

Here’s the rest of the story:

http://www.boston.com/news/local/maine/articles/2007/12/22/judge_shoots_down_maine_law_curbing_access_to_prescription_data/

In addition to First Amendment issues, 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 physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.

When it comes to public health trumping politics -- remember the Maine verdict.  Read More & Comment...

Sicko-San

12/28/2007 10:10 AM |

Hey Michael, I thought this happened only in America

Japanese woman dies searching for care

By CHISAKI WATANABE, Associated Press Writer 37 minutes ago

TOKYO - An 89-year-old woman died after an ambulance crew spent two hours trying 30 hospitals before finding one that would accept her for treatment, Japanese officials said Friday.




http://news.yahoo.com/s/ap/20071228/ap_on_re_as/japan_ambulance_deat  Read More & Comment...

New Poll "Shows" Americans Trust Dems More on Health Care...Of Course They Do

12/28/2007 09:33 AM |

The following article could have been written in any election cycle ...

Pocketbook worries outweigh voters' concerns over war in Iraq
By JIM KUHNHENN and TREVOR TOMPSON, Associated Press Writers

WASHINGTON (AP) — Voters began to worry more about their pocketbooks over the last month — even more than about the war in Iraq....

"...This latest AP-Yahoo! News survey of more than 1,800 people by Knowledge Networks offers a unique opportunity to track changes in public attitudes as the presidential campaign unfolds. The first poll was last month and set a base line to measure national sentiment.

In the new results, men and women approaching retirement were especially attentive to the economy and health care, with six out of 10 ranking both issues extremely important. Politically, the attention to such domestic issues hangs darkly over Republicans. Voters say they are far more likely to trust Democrats to handle the economy and health care."

Consider Linda Zimmerman, a 50-year-old sheep farmer from Thurmont, Md. Her daughter and son-in-law are having trouble keeping up with two mortgages on a town house, she said. One street in her neighborhood has five homes for sale, and one has been on the market for two years.

Registered as a Republican, she's ready to reconsider.

"We're Republicans and I'm very unhappy with them, and I've been watching the Democrats," she said. "We did better when (Bill) Clinton was in than we did with Bush. It's just terrible."

Terrible? Aren't things going better in Iraq? Wasn't that the real downer in America according to the media just a couple of months ago? And how did they ever find a sheep farmer in Thurmont, Md?

As 2008 and the election year approaches, there is really nothing new in the political playbook. For the Dems and the media worse is always better and the good news is always in the past.

http://news.yahoo.com/page/election-2008-political-pulse-voter-worries  Read More & Comment...

Patent Theft Today and Yesterday

12/27/2007 08:38 AM |

Book argues that Bell stole phone idea (AP)

BOSTON - A new book claims to have definitive evidence of a long-suspected technological crime — that Alexander Graham Bell stole ideas for the telephone from a rival, Elisha Gray.

http://tech.yahoo.com/news/ap/techbit_bell_book  Read More & Comment...

Fools on the Hill

12/27/2007 07:31 AM |

Consider the story of Eric Lester, an oncologist in St. Joseph, Michigan, who was trying to find a way save the lives of his patients with advanced lung cancer. Instead of waiting for someone else to develop diagnostic tools, Lester developed his own test to see what kind of genetic factors were causing the cancer to grow. It turned out that epidermal growth factor receptor was the culprit and that a drug called Tarceva, designed to shut off that receptor, would work.

Instead of waiting to use Tarceva when all else was failing, he decided to use it as part of a tailor-made drug cocktail for his patient based on the information from the diagnostic he developed while staying within the bounds of the FDA. The patient fared better than most of the patients Lester sees.

It’s not a cure, but the results of Lester’s experiment—and others like it—are being shared with academic researchers and drug companies to accelerate the development of cancer drugs tailored to variations of growth factors causing lung cancer. Patients like Lester’s would receive tests that look for biomarkers—biochemical indicators of a disease—to see which drug would work best with fewest side effects. Such collaboration could bring about a new generation of cancer-killing treatments in years.

For more check out the Journal of Life Sciences at:

http://www.tjols.com/article-482.html

And that will explain the title.  Read More & Comment...

Socialism Gone Mad

12/26/2007 10:34 AM |

From The Times of London ...

Hospitals fight NHS ban on patients using private drugs

Sarah-Kate Templeton, Health Editor

HOSPITAL chiefs are demanding an urgent review of the government’s policy of withdrawing National Health Service care from patients who pay privately for additional cancer medicines.

The NHS Confederation, which represents hospital chief executives and managers, says denying NHS treatment to patients who pay for top-up drugs is “perverse” and against “common sense”.

The move comes after it emerged that women suffering from breast cancer have been threatened with losing NHS care if they seek to improve their chances by paying privately for an extra drug.

Ministers claim that to allow patients to pay for top-up drugs would be unfair on those who cannot afford them and lead to a two-tier NHS. Their policy was laid down in guidance issued this summer but was criticised last week after The Sunday Times highlighted the case of Colette Mills, 58, from near Stokesley, North Yorkshire.

Mills, a former nurse, has been told that if she pays for the cancer drug Avastin, which the NHS does not fund, she will have to foot the £10,000 total monthly bill for her care.

Another breast cancer patient, Debbie Hirst, 56, from St Ives, Cornwall, has now revealed that she, too, has been told that if she wants to pay for Avastin in addition to her NHS medicines, she will be forced to pay for all her care.

The Royal Cornwall Hospitals NHS Trust issued the threat despite three other patients being allowed to top up their NHS care. The trust says the three had started their private treatment before the guidance was issued.

Hirst, a grandmother, said: “We put our house up for sale in order to pay for this drug. My only option now is to take the treatment they offer on the NHS or go private, which would be totally unaffordable.”

Nigel Edwards, the NHS Confederation’s director of policy, said: “The position appears to run counter to common sense. This should ring alarm bells that something is wrong with the policy.”

Edwards said patients are already regularly combining private and NHS care. For example, thousands mix NHS dental care with treatments available only privately.

Co-payments should be allowed, he said, provided they did not deprive other patients of resources, and those paying for the drugs are well informed of their limitations.

It was also reported yesterday that a 62-year-old woman had won a legal battle for the right to be treated with Avastin for bowel cancer. She will pay for the drug while Cumbria Primary Care Trust funds the rest of her care.

Mills and Hirst are to launch a campaign for all patients to have the right to pay for medicines not funded on the NHS. They are backed by the Patients Association, Doctors for Reform and Saga, the organisation for the over-fifties.

Andrew Goodsell, Saga chief executive, said: “People are less concerned about a two-tier health service than whether they have the opportunity to resolve what can be a life or death situation.”

The health department said: “It is a fundamental principle of the NHS, supported by all the main political parties, that treatment should be free at the point of need. Co-payments would undermine this.”  Read More & Comment...