Rose Law Firm and VA Health Records

03/02/2007 06:39 PM |

Hillary takes credit for starting the health IT revolution at the VA. Given recent reports of health records being stolen and then showing up again unannounced, it sure looks like
it...

Last month, as the following article from computerworld.com shows, " a portable hard drive with information on up to 1.8 million veterans and doctors had been reported missing from its medical center in Birmingham, Ala., on Jan. 22."

VA slow to strengthen IT security  Read More & Comment...

Waxmanic Obsession

03/02/2007 05:15 PM |

Churchill defined a fanatic as someone who can't change his mind and won't change the subject.

Submitted for your consideration Henry Waxman, who continually grinds out studies showing that when government sets drug prices the prices will be lower because it is a monopoly buyer and who endlessly trots out the the case study against academic tenure, Gerard Anderson of Johns Hopkins, to say that other countries negotiate lower prices so we can too, ignoring how other countries systematically starve their systems of new medicines.

So what else is new? We can have low prices and fewer choices..just vote for it. But didn't Democrats scatter like pollen when it came time to put real teeth into a direct negotiation for Medicare?

Drain profits out of drug companies. No problem. Just watch capital flow out of biotech firms including stem cell investment.

I think Waxman might point out that drug companies warned of a loss of investment before generic drug competition and Medicaid rebates and R and D spending has done up. But he ignores the fact the companies were able to increase market prices to offset government policies and many new drugs came on to the scene during the 1990's that were first in class. In otherwords, pricing freedom and innovative products saved the day. What he's talking about now is capping prices and profits on breakthrough drugs now and in the future. And introducing patent stripping legislation with watered down safety standards that mandate generic biologics as 100 percent interchangeable to help them gain market share.

Now that's a fanatic.  Read More & Comment...

Scaring Ourselves Stupid

03/02/2007 04:13 AM |

Spreading fear for profit:
Media, lawyers and interest groups gang up on vaccinations

By JOHN STOSSEL

We can scare ourselves stupid.

Consider vaccines. Robert F. Kennedy Jr. says the mercury in them has "poisoned an entire generation! It's causing IQ loss, mental retardation, speech delay, language delay, ADD, hyperactivity!"

The news media love this kind of story. They repeatedly invite Barbara Loe Fisher, who heads the Vaccine Information Center, to tell parents about vaccine risks. She warns of "seizures, brain inflammation, collapse shock, and, of course ... death."

Causing autism is the biggest accusation. "Before kids received so many vaccines," says Fisher, "you didn't see autistic children. ... We can't build the special-education classrooms fast enough now to accommodate all these sick and disabled children."

Do vaccines cause autism?

Almost certainly not. Dr. Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia, told me, "It's perfectly reasonable to be skeptical about anything you put into your body, including vaccines. And vaccines do have side effects. But vaccines don't cause autism."

He speaks with confidence because the National Academy of Sciences recently reviewed the research and concluded that 19 major studies tracking thousands of kids show no link between vaccines and autism: www.iom.edu/ CMS/3793/4705/20155.aspx "The question has been raised; it's been answered," Offit says.

Then why are so many kids diagnosed as autistic today? As March of Dimes researchers put it, "Changes in diagnosis account for the observed increase in autism." Sure enough, California data show the rise in autism diagnoses almost exactly matches a drop in retardation cases.

"People that we once called quirky or geeky or nerdy are now called autistic," Offit said, "because when you give that label of, say, autistic spectrum disorder, you allow that child then to qualify for services."

Imagine that. A trendy diagnosis being driven by government-paid services.

Vaccine opponents are unconvinced. After my recent TV program "Scared Stiff," they told me they "know" that vaccines caused their child's autism. "Nothing else could have done it."

My heart goes out to parents struggling to help their autistic children, but I fear they have been misled by another anti-drug-industry scare campaign.

I know something about those from personal experience. Twenty years ago, "20/20" interviewed Allen McDowell, a lawyer who said the whooping-cough vaccine was defective. After our alarming report, many parents told their kids' pediatricians they didn't want the vaccine. Some doctors became vaccine-shy.

When my daughter got a fever after one of the vaccines, her doctor decided not to give her the final shot. He said my being a "20/20" correspondent made him even more anxious about the vaccine.

And a short time afterward, my daughter got whooping cough. Luckily, she recovered.

But after media reports like "20/20's" and well-publicized lawsuits, many people refuse to vaccinate their children. And America now sees more cases of whooping cough, mumps, and measles.

Says Offit: "Watch a child come into the hospital and die of measles, knowing that it can be safely and easily prevented by vaccines. It's very hard to live with that."

But Barbara Fisher of the Vaccine Information Center is unmoved. When I asked if vaccines have done more good than harm, she said the matter is "complex."

Lawyer McDowell claims his lawsuits made the vaccine safer. "I'm doing a service for the public," he says.

Nonsense, Offit says. Lawyers didn't make the vaccines better: "There was always an interest in trying to make that vaccine safer, but the science had to catch up to that." He added, "There's a certain profiteering that comes with fear."

Lawyers, the media, and interest groups do profit from spreading fear.

McDowell is now considering new lawsuits claiming that vaccines cause autism. I said to him, "You scare people and make money off it!" After a pause, he replied, "True."  Read More & Comment...

60 Minutes Depressing Part D Feature

03/02/2007 12:51 AM |

For those who want to spend more on filling the donut hole...here's a reminder of what we face unless we make Medicare more market driven, prospective and patient centered..(from the Drudge Report)

U.S. COMPTROLLER: PRESCRIPTION DRUG BILL 'MAY BE THE MOST FINANCIALLY IRRESPONSIBLE LAW IN 40 YEARS'; Bill Will Add $8 Trillion to Long-Term Medicare Obligations
Thu Mar 1 2007 13:41:11 ET

That Could Already Bankrupt the U.S.

The U.S. government's top accountant says the law that added a prescription drug benefit to Medicare may be the most financially irresponsible legislation passed since the 1960s. U.S. Comptroller General David Walker says Medicare -- barring vast reform to the program and the nation's healthcare system -- is already on course to possibly bankrupt the treasury and adding the prescription bill just makes the situation worse. Walker appears in a Steve Kroft report to be broadcast on 60 MINUTES Sunday, March 4 (7:00-8:00 PM, ET/PT) on the CBS Television Network.

"The prescription drug bill is probably the most fiscally irresponsible piece of legislation since the 1960s," says Walker, "because we promise way more than we can afford to keep." He argues that the federal government would need to have $8 trillion today, invested at treasury rates, to cover the gap between what the program is expected to take in and what it is expected to cost over the next 75 years Ð and that is in addition to more than $20 trillion that will be needed to pay for other parts of Medicare. "We can't afford to keep the promises we've already made, much less to be piling on top of them," he tells Kroft.

The problem is the baby boomers. The 78 million people born between 1946 and 1964 start becoming eligible for Social Security benefits next year. "They'll be eligible for Medicare just three years later and when those boomers start retiring en masse, then that will be a tsunami of spending that could swamp our ship of state if we don't get serious," says Walker.

As life expectancies increase and the cost of health care continues to rise at twice the rate of inflation, radical reform in health care will be necessary, Walker says. He says the federal government is also going to have to find ways to increase revenue and reduce benefits. The alternative is ugly. Walker shows Kroft General Accounting Office long-term projections that assume the status quo continues, with the same levels of taxation, spending, and economic growth. By the year 2040, Walker says, "If nothing changes, the federal government is not going to be able to do much more than pay interest on the mounting debt and some entitlement benefits. It won't have money left for anything else...."

Sen, Kent Conrad (D-N.D.), chairman of the Senate Budget Committee, tells Kroft that this problem is well known among members of Congress: "Yes, they know in large measure, Republicans and Democrats, that we are on a course that doesn't add up." And he acknowledges nobody is addressing the matter. Why? "Because it's always easier not to," Conrad says, "because it's always easier to defer, to kick the can down the road to avoid making choicesÉYou get in trouble in politics when you make choices."

Walker believes the biggest problem may be that everything seems okay now, so people don't have the sense of urgency that's needed to make tough choices. But the longer we wait, he argues, the harder it's going to be to solve the problem. "The fact is that we don't face an immediate crisis and so people say, ÔWhat's the problem?' The answer is, we suffer from a fiscal cancer...and if we do not treat it, it could have catastrophic consequences for our country," he tells Kroft.  Read More & Comment...

Conflicted About Conflicts

02/28/2007 06:11 PM |

Drugwonks and CMPI has always been open (why should hide it) about the fact we receive support from pharmaceutical and biotech firms. The last time we looked, there are few industries that actually spend time and money making things that actually heal people and save lives and I have said and wrote in countless settings when called a tool of Big Pharma or some other tired compliment, it is a personal passion of mine to speak up for the scientists and researchers who dedicate their time and effort to discovering and developing and commercializing new medicines. The last time I looked, the critics of industry -- and some criticisms are valid -- haven't developed a new drug, nor have the models they propose -- killing off drug companies in favor of drug discovery/development combines that they would run or would have their own hand-picked people run that in turn would have the standards for approving, prescribing and paying for medicines set by a similar bunch of "untainted" experts would be a disaster, the equivalent of the outpatient unit at Walter Reed.

But that debate is for another day. The point here is the aura of objectivity the critics tend bask in because they are given a free pass by the media. Has the media ever explored the financial and ideological conflicts of the critics? For instance, David Blumenthal, a integral part of the IOM Drug Safety committee has been both a recipient of Commonwealth grants and a reviewer to decide who gets what for the liberal health foundation. Blumenthal is also head of an organization called The Institute on Medicine as a Profession (IMAP) which according to it's website "aims to set forth a vision for professionalism in the 21st century and to promote that vision through research and policy initiatives. "

IMAP received a $7.5 million grant from George Soros who made his money in part from wrecking currencies. IMAP is part of a new venture called The Prescription Project, which is funded by Community Catylst, which in turn is funded by the same group that funds the liberal Families USA which also receives money from Soros. The Prescription Project is being funded by the Pew Charitable Trust to the tune of $6 million but is also linked to the Prescription Access Litigation Project through its affiliation with Community Catalyst. That project is comprised of the largest tort lawyers suing drug companies for a variety of reasons.

The Prescription Project is designed to end companies from having any contact with doctors or patients whatsoever. As the project notes: "Public and private payers spend billions of dollars a year on prescription drugs. When these payers rely on information from industry marketing campaigns rather than unbiased scientific studies, the result is higher cost and poorer quality."

I guess the unbiased scientific studies they have in mind are ALLHAT, CATIE, and the NICE study recommending that the UK's health system not pay for Alzheimer's drugs and new cancer drugs...but that is for another day too

Now guess who is on the board of The Prescription Project: I have done the work for you.

* Jerry Avorn, M.D. Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital
* Patrick J. Brennen, MD, Chief of Clincial Effectiveness and Quality Improvement of the University of Pennsylvania Health System
* David L. Coleman, MD, Chairman, Department of Medicine of Boston University
* Cathy DeAngelis, MD, Editor-in-Chief of JAMA
* Sharon Levine, MD, Associate Executive Director of Kaiser Permanente
* John E. McDonough, Ph.D. Executive Director, Health Care For All, Massachusetts
* Steven Nissen, MD, President of the American College of Cardiology
* Philip A. Pizzo, MD, Dean of the Stanford School of Medicine


PS. Health Care For All is affiliated with Community Catalyst and Families USA

Levine is probably best known for appearing, with her co-star, Jerry Avorn, in the ABC Special hosted by the late Peter Jennings (HMO companies, executive producers) to argue that the rise in the use of new medicine was completely the result of drug ads and added nothing to health.

And Nissen still believes that it is ok to hype the cardiovascular risks associated with drugs for ADHD are dangerous because there is no way so many kids are really ADHD


The fact is, these groups want to advance an agenda. They are receiving funding from liberal foundations to support this agenda. With respect to Blumenthal, it is sad that he was allowed to be on the IOM committee but Nobel Prize winners with real experience in drug development were not by the committee's chair because of conflicts. It is apparent that only one type of relationship is considered wrong: an association with a pharmaceutical firm. I

guess you can take money from currency wreckers who want to de-Nazify America (Soros) and that's ok or liberal foundations and not be conflicted. If history tells us anything the people who are driven by ideology are more willing to twist the truth (e.g. Marcia Angell still claiming that all drugs in a class are equally effective) to advance a political agenda. That is what the Prescription Project and the rest really are. How do we know that Blumenthal's judgment as an IOM member wasn't influenced by his ideology? What about the fact that both of his projects could benefit from the IOM recommendations including the recommendation for lots of evidence based medicine type studies?  Read More & Comment...

The Future of HIV Treatment: Personalized Medicine

02/28/2007 01:11 PM |

Another fine piece by Marilyn Chase (with Jacob Goldstein) in the WSJ on new HIV drugs...

http://online.wsj.com/article/SB117263482927121688-search.html?KEYWORDS=marilyn+chase&COLLECTION=wsjie/6month

The WSJ article (and other media reports) describe the performance of new HIV drugs as "a really remarkable development". Left unsaid is that all these drugs are highly targeted with respect to the mutations of the HIV virus they either attack or block. In particular, Pfizer Inc.'s maraviroc will be launched in combination with a diagnostic called Trofile made by Monogram Biosciences. According to Monogram, the " Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients." Doctors and patieents used the assay throughout the clinical development of maraviroc a patient's likelihood for response and avoid side effects. If approved the combination will help determine if someone will benefit from the drug. (It will be hard for the UK or Canada to deny paying for this drug on any other grounds than to say we don't want to spend the money on saving lives..)

But the FDA will get little additional money to support expanding this approach to development relative to what the fear mongers want to spend on post market clinical trials.....



The WSJ article (and other media reports) describe the performance of new HIV drugs as "a really remarkable development". Left unsaid is that all these drugs are highly targeted with respect to the mutations of the HIV virus they either attack or block. In particular, Pfizer Inc.'s maraviroc will be launched in combination with a diagnostic called Trofile made by Monogram Biosciences. According to Monogram, the " Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients." Doctors and patieents used the assay throughout the clinical development of maraviroc a patient's likelihood for response and avoid side effects. If approved the combination will help determine if someone will benefit from the drug. (It will be hard for the UK or Canada to deny paying for this drug on any other grounds than to say we don't want to spend the money on saving lives..)

But the FDA will get little additional money to support expanding this approach to development relative to what the fear mongers want to spend on post market clinical trials.....  Read More & Comment...

FDA Reform in the New Congress: A Death Sentence for Orphan Drugs?

02/28/2007 11:10 AM |

I received this email from a friend of mine...

"I saw Dr. Scott Gottlieb again today at a meeting of the Food and Drug Law Institute (FDLI). The topic was "Whose Life is it anyway?" and they talked about the Abigail Alliance's lawsuit for earlier access to experimental drugs. Scott gave an appalling example of regulatory creep where the clinical trials for a drug for Hunter's syndrome (one of the mucopolysaccharide diseases) required 100 patients and randomized controlled trial with endpoints being abilty to walk and abilty to breathe! Since it is very rare, he said that the trial likely had to enroll a portion of the world's population in the trial to meet the numbers! He contrasted this with the agency's approval of Cerezyme last decade with about 20 patients! I left the meeting feeling very passionate about the need to do something about regulatory creep and bring more rational clinical trial design to the agency - all of which Scott espoused."

I hope it is not too late...

This latest outrage is just a taste of what's to come under Kennedy-Enzi, Dingell, Stupak, Markey, Waxman, Grassley, Graham, IOM and the coverage thereof of 12 liver problems regarding Ketek hath wrought.... slower cures, fewer drugs, Steve Nissen's god-posturing on cardiovascular problems associated with ADHD drugs,claims that schizophrenia drugs are the next Ketek (meaning the next show trials, which means the next decline in use of drugs for mental illness which will mean another spike in suicides)..

Do any of these preening posturing types care about those who are dying? No, they are too busy trying to explain how watered down biologic standards will produce lifesaving medicines while slowing down orphan drug approvals won't. There are few in official Washington with any passion on this issue. Janet Woodcock of the FDA, Greg Simon of Faster Cures, Frank Burroughs of the Abigail Alliance, Ellen Sigal of Friends of Cancer...The rest could just as well be names drawn from the DC phone directory or in the case of NORD, just a big fat obstacle to change. In fact, NORD should stand for No Orphan Research and Development....

Sorry, just a bad morning.  Read More & Comment...

Reporting Causes High Blood Pressure...And Lowers It

02/27/2007 12:56 PM |

Some of the worst reporting on health surrounds the relative and absolute risks and benefits about medicines. Case in point is the HPV vaccine. As our friend NYU internist and author Mark Siegel points out, the reason for making the vaccine mandatory has less to do with reducing cancer, important on its own, but also genital herpes, abnormal pap smears and other public health problems...

"The problem with combating the human papilloma virus in the United States isn't only cervical cancer or precancerous cells. The problem also is an epidemic of sexually transmitted genital warts. The CDC says HPV causes more than 6 million new cases of genital warts in this country every year.

There are many cases in medical history where vaccination has proved extremely effective in promoting public health even in the face of possible side effects."
http://www.newsday.com/news/printedition/opinion/ny-opsie205101066feb20,0,3529854.story?coll=ny-opinion-print

The coverage of a recent data dredging effort looking at the RELATIVE RISKS of taking different painkillers and high blood pressures for the most part failed to make the qualifications the researchers did. (This was a study of heavy, obese males in the main who were frequent users of all sorts of pain killers against non users that did not control for any other medications) The increase in risk of 33 percent was an increase in risk from 1 percent to 1.36 percent. Leave to scaremonger at the Washington Post
Shankar Vedantam to write a story with the headline : Doctors Warned About Common Drugs for Pain NSAIDs Tied to Risk of Heart Attack, Stroke... Aargh..

But Seniorjournal.com saves the day with straightforward reporting that just gives the facts without the unscientific spin that shady Shankar always seems to give to his stories:

Older Men Regularly Taking Over-the-Counter Pain Relievers have Risk of High Blood Pressure

http://www.seniorjournal.com/NEWS/Health/2007/7-02-26-OlderMenRegularly.htm  Read More & Comment...

First, do no paperwork

02/27/2007 07:31 AM |

Greek physicians of the Hippocratic period would not treat patients they didn’t think they could “cure.” They believed it was bad for the patient (“First, do no harm”) as well as bad for their reputation. This latter point may seem shocking today, but it was not exceptional in ancient medicine – in fact, it was an integral part of the prognosis process.

When such a situation arose, the ancient Greek physician resigned himself to what was called “noble flight.” (An early example, it should be noted, of health care “spin.”)

But such a thing could never happen today, right?

Well, hopefully – but the current debate over pay-for-performance is re-opening the debate, among many physicians, about the wisdom of accepting difficult to treat patients. What’s old is new again. Consider M&M conferences. While never pleasant, they do serve an important purpose. Now imagine if physicians avoided cases they couldn’t “cure.” Is ignorance really bliss? Can we allow remuneration to trump patient care?

And that's precisely what will happen unless we can more precisely define metrics for pay-for-performance programs that take into consideration multiple variables -- the most important being the individual patient. Otherwise we fall into the morass of so-called evidence-based (read "cost-based') medicine rather than patient-centric care. Saving money by providing anything other than optimum treatment (pharmaceutical and otherwise) is not only penny-wise and pound foolish from an outcomes perspective -- it's also just plain ethically wrong.

Health care isn't a yes/no proposition. The ancient Greeks thought in terms of "cure." Today we think in terms of "treatment." And "treatment certainly isn't binary.

After all, is the ancient Greek fear of damage to one’s reputation really any different than today's fear of reduced payment? We've come too far to stumble on such petty grounds.  Read More & Comment...

The Renal Disease Sweepstakes

02/26/2007 08:54 AM |

The British have always been fond of the Irish Sweepstakes. Unfortunately (and once again) NICE and the NHS are asking patients with kidney disease to play the Renal Disease Sweepstakes.

Should health care really be a crap shoot with terrible odds?

Kidney cancer victims denied "wonder drugs"

The Sunday Times (London) By Daniel Foggo and Sarah-Kate Templeton;
25 February 2007

Two new "wonder drugs" with the potential to prolong the lives of thousands of kidney cancer sufferers are being denied to National Health Service patients because they are too expensive.

The drugs, Sutent and Nexavar, have been shown to shrink tumours dramatically, with some disappearing altogether. Both have been licensed for use in Britain but the NHS has so far declined to issue guidance that trusts should fund the drugs.

Without such guidelines, patients are dependent on the judgment of individual NHS trusts deciding whether or not they can afford the treatment, which costs about £2,500 a month. Some cancer sufferers have been forced to sell their houses or cash in pension schemes to pay for the treatment.

The situation has been likened by doctors to the furore over Herceptin. The breast cancer drug was not routinely prescribed until August last year, following intervention by Patricia Hewitt, the health secretary.

Nicholas James, consultant in clinical oncology at Queen Elizabeth hospital, Birmingham, said of Nexavar: "Patients with this cancer tend to die quite quickly but I know from my own patients who were on the trial how well this drug works. They are still alive two years later."

Despite the enthusiasm of doctors, the National Institute for Health and Clinical Excellence, which draws up the NHS's policies on whether trusts should fund medicines, has so far set no timetable for assessing the two kidney cancer drugs.

As a result, patients can obtain the drugs only through a private doctor or by asking their GP to plead their case individually to primary care trusts (PCTs).

Kidney cancer, which is diagnosed in about 6,600 people each year, has a death rate of more than 50% and is difficult to treat, with both radiotherapy and chemotherapy of little use.

Until the development of Sutent and Nexavar, which both work on the principle of starving tumours of their blood supply, the only viable treatment was the drug interferon alpha.

But in trials of Sutent it was shown to more than double the time tumours remained static in size compared with interferon. Nexavar had similar results.

Professor Robert Hawkins, an oncologist at Christie hospital in Manchester, who conducted a recent Sutent trial, said: "We have had a couple of patients where the cancer seems to have disappeared altogether." At least one patient -- who served in the RAF -- is seeking judicial review over the drug. It was similar action over Herceptin that contributed to its approval as an NHS drug.

Janine Handrick, 35, a travel adviser and mother of five-year-old Madison, is one patient who, with her GP, managed to persuade her PCT in Doncaster, South Yorkshire, to put her on Sutent in December.

"I was diagnosed with cancer last March when they found lumps on my right kidney and in my coccyx," she said. "They removed the kidney but it had spread to my bones and lungs. When the nurse told me they had found tumours, I asked if I would die and she just nodded.

"When my doctor told me they had decided to give Sutent to me, I was ecstatic, although I won't know how effective it is until I have a scan in another six weeks."

Mark Franklin, 39, a builder from Buckinghamshire, was also facing death when he was included in a trial of Sutent last June. The cancer had spread from one kidney, which was removed, to his ribs, lungs, back and other kidney. Now his tumours have shrunk dramatically and this May he plans to climb Britain's three highest mountains.

"There is no doubt I would be dead now if it wasn't for the trial," said Franklin. "Not making this drug available to everyone on the NHS is criminal."

He is one of almost 1,000 signatories so far to an e-petition on the 10 Downing Street website calling on the prime minister to make Sutent and Nexavar freely available.

A spokesman for Kidney Cancer UK said: "These drugs are available in much of Europe and the US but here it is a postcode lottery. We are taking legal advice on whether PCTs can refuse to prescribe these drugs because of cost."

The real saving, in mortality, misery and expense, would come from earlier detection. My cancer, slow-growing and occupying about one-fifth of my left kidney, was detected by ultrasound, which was administered for another reason. This was some ten years before I should have noticed any symptoms, and before the growth could spread to other organs. Partial nephrectomy, with biopsy of a surrounding margin in the operating theatre, was sufficient. I now have one and three-quarters healthy kidneys. Radical nephrectomy will be needed only if my annual ultrasound shows that cancer has recurred in that kidney, and partial nephrectomy is still in reserve for the other side if cancer should be detected there.  Read More & Comment...

Mandatory HPV? Yessiree.

02/26/2007 08:42 AM |

When we disagree with the New York Times editorial page, we say so. Today we strongly agree with their position on mandatory HPV vaccinations. Here's what the Gray Lady has to say ...

A Necessary Vaccine

Debate over a new vaccine to prevent cervical cancer and genital warts has reached a high pitch. State legislatures are debating whether to mandate the vaccine or insist that its use be kept voluntary. The manufacturer stopped a vigorous lobbying campaign lest it provoke more opposition than support. And some health professionals who had been championing the vaccine flinched at making it mandatory, at least for now.

Even so, state legislatures should require that all young girls be given this vaccine, which protects against a virus that causes some 10,000 new cases of cervical cancer in the United States each year — and 3,700 cancer deaths.

Three weeks ago we applauded Gov. Rick Perry for making Texas the first state to require vaccinating young schoolgirls — ages 11 and 12 — against the human papillomavirus. In the ensuing uproar, the Texas House has moved to overturn his order, but the Virginia Legislature has approved a similar mandate. Some 20 states have bills pending to require the vaccinations for school attendance.

We have endorsed a mandate because the vaccine — Merck’s Gardasil — looks highly effective against strains that cause 70 percent of all cervical cancer. With more than two million doses already distributed, the reported side effects have been mostly minor, such as dizziness or fainting. Many parents who oppose a mandate are aghast at the thought of vaccinating such young girls against a sexually transmitted disease. But the vaccine works only if taken before a girl becomes infected. Social conservatives object that the vaccine will encourage promiscuity, but it seems farfetched to believe that protection from cervical cancer will change any girl’s behavior. Others complain that a mandate will pre-empt parental rights to make health decisions, but all vaccine mandates do that, to protect the children and those they might infect.

The strongest arguments against moving ahead quickly tend to be practical and financial. States have typically used school mandates for vaccines that are already in wide use, and it is possible that unexpected side effects could emerge (though any mandate could be suspended if that happened). Health professionals also need to be certain that there are stable supplies, adequate insurance coverage, ample public money to vaccinate low-income children and physician support.

Merck deserves praise for developing Gardasil at a time when many companies shun the vaccine business as risky and unprofitable. But it is charging $360 for a three-dose regimen, a price that might come down if a competing vaccine enters the market soon, as expected.

The vaccine could prevent thousands of new cases of cervical cancer annually and hundreds of thousands of cases of genital warts and precancerous growths. A mandate would force the health care system to get cracking. And it is the best way to ensure that all children get the vaccine, not just those who are aware of it and can afford it.  Read More & Comment...

T-Shirts Don't Kill

02/24/2007 07:11 AM |

According to Dr. Valerio Reggi, chief of the anticounterfeiting task force created last year by the WHO (and as reported in the New York Times), in many countries, "counterfeiting a T-shirt means 10 years in jail, but counterfeiting a medicine can be a misdemeanor."

A deadly misdemeanor.  Read More & Comment...

Supporting Our Troops

02/23/2007 04:51 PM |

In the wake of the scandal surrounding third world outpatient care for our troops at Walter Reed comes this riposte from prize winning war correspondent Joe Galloway:

Chris Adams's Feb. 9 report that even by its own measures, the Veterans Administration isn't prepared to give returning veterans the care they need to help them overcome destructive, and sometimes fatal, mental health ailments. Nearly 100 VA clinics provided virtually no mental health care in 2005, Adams found, and the average veteran with psychiatric troubles gets about a third fewer visits with specialists today than he would have received a decade ago.

Here's the Chris Adams piece about the VA system pols want to expand to provide drug benefits for us all.
http://seattletimes.nwsource.com/cgi-bin/PrintStory.pl?document_id=2003566773&zsection_id=2002107549&slug=vets11&date=20070211
I want Ron Pollack to be the first one to enroll himself and his family

Mrs Clinton and her followers should be next...
Contrast this with Hillary's bubbly view of the VA -- her shining model for national health care since her last iteration, regional health gulags, crashed and burned...."The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning. The other thing the VA has done to keep costs down is negotiate for drug prices with the drug companies."  Read More & Comment...

Good Article But Selective Reporting?

02/23/2007 08:59 AM |

Marilyn Chase had an good piece in the WSJ about how doctors and consumers have driven the debate over whether to use Avastin off label to treat macular degeneration for about $40 a dose or the drug Genentech developed for the disease and for which it received FDA approval. Lucentis is administered in the form of smaller molecules, which is thought to give Lucentis an advantage over Avastin in its ability to penetrate the eye's retina and halt abnormal blood vessel growth contributing to advanced macular degeneration and scarring that causes blindness. But opthamologists think otherwise. They began using Avastin as a placeholder while Lucentis was being developed and have stuck with it because it is cheaper and see no reason to change. Now the NIH is seeking to conduct a head to head trial which, if it goes the way of all large scale trials,will show no difference except in terms of side effects which is a huge exception since it relates directly to individual response to doses. And that is something that Judah Folkman observed in the Phase I trials of Avastin way back when but back then the FDA insisted everyone had to get the same dose.

So the head to head trial is really a product of one size fits all science, not Genentech's evil effort to milk profit out of Avastin, For perspective, note that in it's recent study to determine the effectiveness of Avastin in lung cancer, Genentech found that a smaller dose was as effective as a higher dose. It would behoove Genenetch and those who are setting up the Lucentis trial as a sentinel event for government run comparative effectiveness research to look at which patients do best at which dose and molecule size. That's where medicine is heading. And if we want to avoid across the board reimbursement decisions that drive one size fits all medicine, Genentech and other companies are going to have to get ahead of the curve as it did with Avastin in lung cancer. It must change the conversation with consumers and doctors by giving them different and better information.

As it can see (no pun intended), the media will not do it for them....

Genentech's Big Drug For Eyes Faces a Rival  Read More & Comment...

Japan's Cancer Refugees

02/23/2007 07:09 AM |

At first glance, Japan's health-care system seems superior to America's. Its infant mortality rate is among the world's lowest. Japan's life expectancy is the world's highest for women (85.6 years) and the fourth-highest for men (80.4 years).

All this has been achieved at a fraction of what the United States spends. Only 9 percent of Japan's gross domestic product is spent on health care, while America spends almost twice that. It seems like the perfect system. For many, perhaps it is -- unless you actually need to use it ... and particularly if you have cancer.

Have a look at this new op-ed that appears in the Commentary section of today's edition of The Washington Times:

http://www.washingtontimes.com/commentary/20070222-084946-2121r.htm

A health-care system's success shouldn't simply be based on life expectancy and fiscal policy but rather on individual outcomes.

Candidates in the 2008 presidential race have already begun vying for Americans' votes. Improving the nation's health-care system has already surfaced as a major issue for all those seeking the job. But it's hardly an improvement on our health-care system if politicians seek to turn our life-and-death health-care decisions over to bureaucrats and budget-crunchers.

Japan's cancer refugees have just issued a wake-up call to their own government. It would be a shame if we didn't heed their warning and ended up with cancer refugees of our own.  Read More & Comment...

Evidence-Based Medicine? G'Day Mate

02/22/2007 07:14 AM |

Recently I spoke at a joint California Healthcare Institute/Pacific Research Institute conference on evidence-based medicine -- with a particular focus on how it isn't working all that well Down Under, and a few important lessons we should learn from the Aussie experience.

Here's a video podcast of my remarks:

http://sys-con.com/read/340224.htm

Enjoy.  Read More & Comment...

Why Blog When Someone Else Will Do It For You

02/21/2007 10:29 PM |

Here's Derek Lowe of pipeline.Corante.com blogging about his take of our first Media and Medical Science conference.... Derek talks like he writes, witty, unvarnished and informative ...

In The Pipeline

We had wonderful attendance, great moderators and panelists, including another first time blogger, Ed Silverman who just launched http://www.pharmalot.com

Can I get away with just saying that 1. coverage does drive policy and that the more science based the coverage, the better the policy and 2. everyone that has skin in the game has an obligation to, in the words of Greg Simon, "stop whining (which he said with a smile) and start working to change the conversation" 3. everyone needs to do a better job explaining what drug and biotech companies do.

Key words.... consumerism, transparency, honesty, benefits, skepticism (on the part of the media ) biomarkers.  Read More & Comment...

Medicine and the Media

02/21/2007 06:10 AM |

Today CMPI is hosting "Medicine and the Media: Redefining Roles and Responsibilities." If you can't make it to DC for this event (and we hope you can), please join us via audio webcast. Sign-up information can be found by clicking on the link below:

http://www.visualwebcaster.com/Stratosphere/37936/reg.html

And if you can't join us for the whole day, please be sure not to miss FDA Commissioner von Eschenbach's lunchtime speech on "FDA and the Media."

Hope you can join us.  Read More & Comment...

Baht on a Hot Tin Roof

02/20/2007 03:42 PM |

Imagine a world without intellectual property protection. Now stop imagining and start paying attention to what's going on in Thailand.

Have a look at this new op-ed in today's Baltimore Sun ...

http://www.baltimoresun.com/news/opinion/oped/bal-op.patents20feb20,0,89958.story?coll=bal-oped-headlines

... and let's talk.  Read More & Comment...

We're The Good Guys!!!

02/20/2007 10:01 AM |

In light of the pro-generic tilt of public policy these days the following sidebar from the Pharmaceutical Business Review might be of interest:

Ranbaxy has revealed that federal officials have conducted a surprise raid at its New Jersey offices and manufacturing site, during which paper and electronic documents were taken. Although the raid is believed to have been carried out by the Food and Drug Administration, the agency has not confirmed this report. The Indian-based generic drug firm claims to be mystified by the raid, and insisted that it was not aware of any wrongdoing. As the FDA refuses to comment on ongoing investigations, the reasons behind the swoop will remain a mystery for the time being.

It should be noted that Ranbaxy told the Indian press that they think the brand companies are behind the raid. Maybe Jamie Love can explain this connection.
The PBR report does not note that the Department of Justice is conducting the investigation and it does not rush in unless it has good reason to do so. My guess is that it might have something to do with fudging on filings, something Ranbaxy has done before.

Memories are short but some might recall that in 2004 the WHO had to delist Ranbaxy's HIV drugs when it found that it had no safety and efficacy data for them. As the WHO noted then: "The drugs will be delisted until Ranbaxy can submit data of new studies providing unequivocal evidence of the products' bioequivalence with the originator medicines."

Ouch.

Ranbaxy did get FDA approval for a couple of HIV drugs in 2005. But what does that say about all those patients taking drugs based on files that the WHO couldn't even accept...

This is a story worth following in light of the corruption and shoddy products the junta-run drug company in Thailand is getting ready to pump out...

And these are the good guys Waxman, Love and co are supporting.  Read More & Comment...