Want an off-label combination of drugs...Not under Kenzi you don't

03/09/2007 04:27 PM |

Great piece in Technology Review about how bioinformatics wil lead to tailored combos of drugs to treat diseases according to who were are and what we need...

"A biotech company called CombinatoRx has found that at the right doses, thousands of counterintuitive drug pairs are synergistic. The Cambridge, MA, company has eight drug combinations in clinical trials and several more in preclinical development. In a few years, diabetics, instead of injecting insulin, might be prescribed a cholesterol drug and a pain medication to help control their blood sugar. People suffering from chronic pain might find relief through a combination of a steroid and an antidepressant, with fewer side effects than they experience with current therapies.

Alexis Borisy, founder and CEO of the company, says his researchers take a brute-force approach to finding fruitful drug combinations. In the lab, they test combinations of several thousand drugs at several different doses on cellular models of diseases including cancer and arthritis--regardless of what diseases the drugs are currently approved for, if any. Then they feed the data into software that looks for synergies."

The entire article and link thereof can be found here:

http://www.technologyreview.com/Biotech/18280/

Just one problem....for every combo you will need.....a Risk management plan under the enlightened regime of Kennedy Enzi. Otherwise you and your doctor will be subject to some sort of liabiity and likely be denied reimbursement by an equally enlightened insurance or health plan.

Meanwhile Big Pharma lobbyists work with the staffers in Enzi and Kennedy's office for minor changes in the bill. Don't they realize that in a matter of days the Waxmaniac is going to drop his mutated version of Kenzi, complete with a comparative effectiveness study requirement?

What's counterintuitive is that people are still failing to ask just how Kenzi will affect access to lifesaving medicines and cripple the doctor patient relationship...  Read More & Comment...

Kids R'nt Us ... Yet

03/09/2007 03:22 PM |

Here's the lead from a story that ran earlier this week in the Philadelphia Inquirer on a new study showing that nearly 80 percent of the children cared for at academic children's hospitals got at least one medicine outside the age parameters approved by the FDA:

"Most children treated at major pediatric hospitals are given medicines not approved by the Food and Drug Administration for use in patients so young. The study, in today's Archives of Pediatrics & Adolescent Medicine, found that the sickest children and those undergoing surgery were most likely to get a so-called off-label drug. But altogether, nearly 80 percent of the children cared for at academic children's hospitals got at least one medicine outside the age parameters approved by the FDA."

Why is this so? Well it's because of the big, bad, evil pharmaceutical industry don't ya know:

"The risk and benefits of many drugs in children are poorly studied, often because the drugmakers had little financial incentive to do so."

Well, not precisely. It's not the financial incentives so much as the difficulty relative to the return. I know, that sounds like verbal gymnastics. Try this -- the real issue is that FDA permitted pediatric clinical trial design makes it difficult if not impossible to precisely determine which medicines in what dosages work in specific circumstances in specific pediatric patient populations. In other words, if personalized medicine in adults is difficult, in children it is nearly impossible.

Yet another important reason for the FDA to embrace adaptive clinical trial design and to become a research hub for 21st century clinical trial design. And that, of course, is part of what makes the Critical Path program so, well, critical to the future of America's health.

Here's a link to the Inquirer article:

http://www.philly.com/mld/inquirer/16841956.htm

According to Samir S. Shah, the study's lead author and infectious-disease doctor at Children's Hospital of Philadelphia, "We don't know whether in the absence of off-label use there would have been fewer deaths or more deaths. I suspect that in many instances the drugs were beneficial and in a smaller number of cases the drugs were harmful."

That's good news. What would be even better news would be getting the right drug in the right dose to the right child at the right time based on sound science and under the FDA's imprimatur.

Tempus fugit.  Read More & Comment...

Ted Kennedy's Sensible Statement on Follow on Biologics

03/09/2007 12:51 PM |

Compare this to the banshee cry of predetermined interchangeability as advanced by Waxman and the self-serving Express Scripts savings estimates from follow ons

I welcome the members of our committee and our distinguished witnesses to today’s hearing on the important question of whether Congress should give FDA the authority to approve follow-on versions of biologic medicines.

We are in a remarkable period of discovery in the life sciences. Unprecedented advances are taking place, and patients have already begun to see the benefits of this new era through new wonder drugs that can make the difference between life and death for patients afflicted with serious illnesses.

Patients with leukemia who once faced a bleak future now have new hope, thanks to an extraordinary new medicine that can slow or even halt the progression of the disease.

Until recently, a diagnosis of Gaucher’s [“go-SHAYS”] Disease meant a shorter life, full of disability and pain for the people it afflicted. Now, a remarkable breakthrough has produced drugs to treat this grave illness and extend life and reduce disability.

Similarly, a drug to stimulate the production of new blood cells is helping patients counteract the severe anemia caused by chemotherapy or renal disease.

These miracle medicines, called biologics, are complex molecules whose healing power has been brought to patients by dynamic biotechnology companies. Such drugs were once a rarity in the medical arsenal, but each day seems to bring new hope from new breakthrough biologics.

With this extraordinary progress comes a challenge to public policy. Due to the cost of developing and manufacturing new biologics, their price is often steep. They can cost patients tens or even hundreds of thousands of dollars a year, putting an extraordinary strain on the budgets of those who must pay the bills –patients, insurers and companies, or government programs.

Congress has faced similar challenges before. In the early 1980's, the cost of prescription drugs was spiraling upward. In response, Congress enacted legislation that balanced the need to reduce costs for consumers through increased competition with the requirement to promote innovation. That legislation is known universally by the names of its sponsors, Senator Orrin Hatch and Representative Henry Waxman. Our committee is honored that Senator Hatch is helping guide our deliberations. Congress and the American people are indebted to his leadership on these important issues.

When the Hatch-Waxman law was enacted, Congress did not include biologics, because at the time such drugs were not providing the major innovations that advances in the biological sciences have brought over the past 20 years.

Now Congress must consider whether to authorize FDA to accept applications for follow-on versions of these path breaking medicines.

The stakes riding on the answer to this question are enormous, both for patients and for our economy, and the interest among our committee colleagues in this question is intense. One of our colleagues, Senator Clinton, has a proposal to allow FDA to approve follow-on biologics. I look forward to hearing her views on this question, and to receiving the testimony of the legislation’s co-sponsor, Senator Schumer.

Many have recommended that the committee’s legislation on drug safety and user fees should include a proposal to allow for follow-on biologics. Today’s hearing will help to provide the information the committee needs to make the right decision on that important question.

Our committee should be guided by three basic principles.

First, we must be led by science. Acceptable legislation on follow-on biologics must not pre-judge science, but should enable the FDA to make the best decisions based on the most complete science reasonably available.

Second, protecting patient safety is essential. Congress must make certain that any drug given to patients – whether a conventional drug, an innovative biologic, or a follow-on product – is safe and effective.

Third, innovation must be valued and promoted. Just as it is essential to help patients afford the medicines of today, so too it is vital to provide incentives for the innovations that will bring the medical miracles of tomorrow.

I look forward to the recommendations and insights of our distinguished witnesses to provide guidance to our committee as we undertake these important deliberations.  Read More & Comment...

Friends of Cancer Research Drug Safety Briefing

03/09/2007 12:47 PM |

Drug Safety Briefing: "Drug Safety: Defining Safe"

On March 21st, Friends will host an educational congressional briefing on Capitol Hill entitled “Drug Safety: Defining Safe.” Featuring introductory remarks from Representative Diana DeGette (D-CO), the briefing will include expert panelists Dr. Robert Young, President of Fox Chase Cancer Center; Dr. Mark McClellan, Former Administrator of CMS & Former Commissioner of FDA; Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer of FDA; and patient advocate Dan Perry, Executive Director of The Alliance for Aging. Susan Dentzer of The NewsHour with Jim Lehrer on PBS will moderate. For more information, please contact Heather Chaney at hchaney@focr.org or (703) 302-1540  Read More & Comment...

Does Waxman Still Stand With Thailand's Thugs?

03/09/2007 12:02 PM |

Henry Waxman sent a warm letter of solidarity when Thailand's military junta seized the patents of HIV drugs recently. The number of pharmaceutical patents rose to 11 and the range of products that the Thai government's drug company -- which has never been able to make WHO quality medicines -- would copy has expanded to include cancer and heart disease in the wake of Waxman's love letter.

Nothing like appeasement to embolden a global bully. In the January board meeting of the WHO, Thailand 's representative, Dr. Suwit Wibulpolprasert, declared that if an influenza pandemic hit, he'd counsel Bangkok to hold Western tourists hostage until those countries gave Thailand the necessary vaccines.

And if they didn't?

I wonder what sort of letter Waxman is planning to write now.  Read More & Comment...

Randomized To Death

03/09/2007 10:18 AM |

Here's what Susan Horn, one of our board members, an one of the world's experts on the science of improving outcomes in healthcare has to say about the crushing limiting randomized clinical trials have had on the quality of care for veterans with traumatic brain injury. It has implications not only for what is happening through the VA hospital system but for those who would use RiskMap as a one size fits all conduit for determining who gets access to medicines:

" The 1998 NIH consensus statement (about treating traumatic brain injury) acknowledged that individually tailored treatments provided within the context of acute rehabilitation create difficulties for efficacy studies. “This personalized approach leads to great difficulty in the scientific evaluation of effectiveness, because there is significant heterogeneity among persons with TBI and their comprehensive treatment programs”. The current level of evidence limits our ability to make firm decisions about the best therapy interventions, intensities, durations, or staffing characteristics for inpatient TBI rehabilitation. Also, randomized clinical trials severely limit the number of interventions that can be tested at any one time. Randomized trials attempt to examine an intervention in isolation from other interventions in order to detect the unique contribution to recovery of one or at best a few variables."  Read More & Comment...

(VA) Care To Repeat That?

03/08/2007 09:50 PM |

"We started during the Clinton administration to transition the VA system to a paperless system....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."

Hillary Clinton

"If you take a look at how the VHA system works, it's much more flexible getting drugs that are not on the list than the private plans are. And so people get the worst of all worlds: They have a more rigid formulary under Medicare, and the prices are much higher."

Ron Pollack FUSA

"Who do you think receives higher-quality health care. Medicare patients who are free to pick their own doctors and specialists? Or aging veterans stuck in those presumably filthy VA hospitals with their antiquated equipment, uncaring administrators, and incompetent staff? An answer came in 2003, when the prestigious New England Journal of Medicine published a study that compared veterans health facilities on 11 measures of quality with fee-for-service Medicare. On all 11 measures, the quality of care in veterans facilities proved to be "significantly better."

Philip Longman, Washington Monthly, 2005 from an article The Best Care Anywhere that boasted: "Ten years ago, veterans hospitals were dangerous, dirty, and scandal-ridden. Today, they're producing the highest quality care in the country. Their turnaround points the way toward solving America's health-care crisis."  Read More & Comment...

Can We Think Of Anything Else For the FDA To Do?

03/08/2007 06:48 PM |

Today the Senate reintroduce legislation to require the FDA insure that packages, wholesalers and manufacturing plants in Europe -- all old drugs of course -- are safe. The bill also requires the FDA to claim that drugs with different coatings, formulations, doses but same active ingredients are as safe and effective as products made to US spec.

Earlier this week, the Senate introduced a bill that would require the FDA to come up with a standard and process for approving -- I am not making this one up -- a safe cigarette.

Previously, Congress introduced a bill requiring the FDA to approve certain knock-off versions of biotech drugs as generic and as interchangeable without any safety tests or risk management or life cycle management strategies,

Previously still, legislation was introduced which required the FDA to set up a risk management program for every drug on the market and every new one being developed...except for imported drugs and generic biologics.

The FDA is still responsible for approving new medicines. I think.

But not until they improve spinach inspection and beef up labeling on peanut butter and organic foods.  Read More & Comment...

Will RiskMap Criminalize Off-Label Prescribing

03/07/2007 05:11 PM |

Let's say you are a leading clinician researcher in the area of auto-immune disorders and a new drug for rheumatoid arthritis has a risk management program attached to it that limits prescribing to patients with RA and to RA specialists. However because of the drug works on a particular pathway you, because of previous research, have a hunch, it will work fine on patients with lupus. Or what if you want to use a new antibiotic to suppress an infection in CF patients but the RIskmap plan limits it to organ rejection use. If you use it (or if you can even get it) for an off-the-map purpose are you liable, criminally or civilly? Could you lose your medical license? Do patients have to wait to enroll in a clinical trial for every novel use? Will medical innovation grind to a halt? Will patients die because they are not on The MAP?  Read More & Comment...

Cuba's Innovative Pharmaceutical Industry: I'm Crazy For Castro's Coca

03/07/2007 07:13 AM |

For all those eager to kill off the US pharma industry, no need to worry, Cuba is filling the void with an ambitious program to find a use for coca leaves for every ailment. Who needs stem cells when you have the precursor for cocaine from Castro's labs?

Scientists seek coca's medical benefits

By DAN KEANE, Associated Press Writer Tue Mar 6, 6:54 PM ET

LA PAZ, Bolivia - Cuban scientists are studying the possible medicial benefits of the coca leaf, a Bolivian official said Tuesday, signaling a possible expansion of President Evo Morales' plans to develop more legal products from a plant that is the chief ingredient of cocaine.


http://news.yahoo.com/s/ap/20070306/ap_on_sc/bolivia_cuba_coca  Read More & Comment...

Son of Prescription for Trouble

03/06/2007 12:22 PM |

I have created a new category in honor of Scott Gottlieb's latest and greatest oped in the Wall Street Journal. (See Peter's post below) This will catalog the various efforts of Washington types to politicize science or regulate the practice of medicine according to a specific ideological agenda without debate or transparency or regard to science. The gold standard for such meddling or micromanagement will likely be a battle between Waxman and David Graham now that Senator Grassley is in the minority.

Here's the first entry of the spring training season for this :

Congressional Panel to Study
Off-Label Use of Stents, Drugs
By KEITH J. WINSTEIN
March 6, 2007; Page A12

A congressional committee is looking into the "off label" use of drugs and heart stents, examining the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration.

Boston Scientific Corp. and Johnson & Johnson's Cordis unit, the only makers of drug-coated stents sold in the U.S., were asked to submit marketing materials and clinical data to the House Committee on Oversight and Government Reform on Wednesday. About 60% of drug-coated stents, which prop open clogged arteries, are used off-label. For example, manufacturers haven't rigorously tested their stents in patients who have had heart attacks, but stents are commonly given to such patients. Doctors are allowed to prescribe stents to off-label patients, but manufacturers can't encourage off-label use.

The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.  Read More & Comment...

The Innovation Agenda

03/06/2007 12:10 PM |

My article in the Washington Times of Monday on how some in Congress want to take a good idea -- follow on biologics -- and turn it into a public health threat just to rake in some more cash for social welfare spending....

Nancy Pelosi has a knack for the ironic. In unveiling what she called her party’s “Innovation Agenda”, the Speaker from American Samoa proclaimed: “America (is) the breeding ground for the innovations and inventions that increased our prosperity, enhanced our lives, and protected and advanced our freedoms. That dynamic and virtuous cycle of innovation is what secured our status as world leader, and that status has remained unchallenged – until now. “

Little did we know that the challenge Ms. Pelosi was referring to is the Democrat party itself.

In January, Henry Waxman, touting a Families USA study promised that direct government negotionats with drug companies would save Medicare $190 billion, enough money to pay for every senior’s out of pocket drug costs as well as expanding health insurance for kids and rehab for Britney Spears. The savings disappeared when it became evident they were only achievable if Medicare robbed seniors of access to many lifesaving drugs.

Democrats are still short the money. So they plan to get it by stopping that virtuous cycle of innovation in biotechnology. The Murtha plan for stopping the surge is being peddled as a “support the troops plan.” The Access to Lifesaving Medicines Act offered by Congressman Waxman, Senator Charles Schumer, Senator Clinton and termagant Republican Congresswoman Joanne Emerson, creates generic versions of biotech drugs to free up money for social programs, is shrewdly devised as a consumer protection measure. In the process, Waxman and others weaken drug safety and patent protection standards to enrich the generic drug industry.

Ironically (again) in touting the Innovation Agenda, the Speaker from Samoa proclaimed:
“Essential to our pre-eminence is the protection of intellectual property. Our agenda commits to protecting the intellectual property of American innovators worldwide.”

Not when it stands in the way of expanding the welfare state. Recently the military dictatorship running Thailand following the advice of anti-intellectual property activists (who care more for shredding corporate patent rights than protecting human rights in Thailand), said it would use its Government Pharmaceutical Organization to make generic copies of the heart drug, Plavix and two HIV drugs Kaletra, and Stocrin.

It has also threatened to seize the patent of 11 new drugs including Lipitor and Gleevec. Thailand claims it needs to make or import generic drugs to treat everyone with every disease. The junta – which has military monitors in every pressroom – received a warm endorsement from Congressman Waxman. All hail the Revolution!

Waxman and other Democrats cloaked their efforts in the concern that giving generic companies the license to produce these drugs will make medicines affordable for all. In fact, in 2002 Thailand’s GPO failed to meet the WHO’s drug quality standards. Worse, the drugs were so shoddy that they caused drug resistance, forcing patients to take a second regimen of drugs that raised overall infection rates and treatment costs. And even then, most of the $3 million worth of drugs are exported. The percentage of infected Thai people receiving treatment is among the lowest in the developing world.

So what if generics don’t really increase access to effective medicines? That’s not the goal. Weaker IP allows the Thai junta to line their pockets with the proceeds made from copycat products they can sell at huge margins, money they can then turn around and spend to reward cronies and buy political support.

Similarly, the so-called Access to Life-Saving Medicine Act – simply asserts it is scientifically safe to both produce generic clones of biotech drugs and switch people from the biotech products they are using to generic versions. Making similar but not exact versions of biotech drugs or vaccines that have the same clinical benefit without all the early clinical work required for an innovator product will be possible in the near future. But the Waxman/Clinton/Schumer bill is based on 40-year-old science. And it demands no the testing of comparison products before or after there are marketed. Worse, it dictates to the FDA that the products must be approved as interchangeable.

Ironically, the same group of legislators who claim the FDA is unable to maintain the safety of existing drugs is pushing this legislation. Indeed, Waxman claims he is “justifiably skeptical of any effort to weaken the standards which assure that our food is safe and our medicines are safe and effective.”

Out of nowhere and not because someone asked them to, Express Scripts (which manages drug benefits would benefit from cheaper biotech products) did a study estimating the savings from follow on biologics. In what will be news to most biotech firms, tithe ‘study’ assumes many biotech products have already lost patent protection and those most products will immediately lose market share when the rest of the products do. The estimated savings over ten years-- $70 billion – coincidentally add up to the amount required to expand the child’s health insurance program.

I wouldn’t count on it. The FDA approved a comparison human growth hormone product called Omnitrope in 2006 based partially on data from Pfizer’s growth product, Genotropin. But Omnitrope also underwent years of clinical tests. During these tests researchers discovered 60 percent of children developed infections to Omnitrope. The company had to do more studies and adjust its production process before it was approved. Omnitrope was never launched in America. In Europe, it has less than 1 percent of the market.

I don’t think Americans bargained for the Democratic assault on innovation when they took power. The party, (along with mean-spirited Republicans like Ms. Emerson), has become the political vehicle for opposing medical advances against disease. The Access to Lifesaving Medicines Act is the first ironic attack. It won’t be the last.  Read More & Comment...

Prescription for Trouble

03/06/2007 09:59 AM |

From today's edition of The Wall Street Journal ...

Prescription for Trouble
By Scott Gottlieb

Inside the federal agencies that oversee parts of the health-care system, there is a palpable view that doctors can no longer be trusted to do the right thing.

The Food and Drug Administration, Medicare and even the Justice Department all believe they cannot rely on many doctors to heed safety warnings, wisely weigh new medical information, or follow treatment approaches that maximize health benefits or lower costs. So in recent years, these agencies have hatched rules that dictate when treatments should be delivered and even how they can be administered -- especially when it comes to new drugs.

The result is increasing federal regulation of medical practice that constrains health-care providers and limits the choices patients have. It might get worse. New legislation offered by Sens. Edward Kennedy (D., Mass.,) and Michael Enzi (R., Wyo.,), intended to make drugs safer, would raise this regulatory burden by reducing a physician's discretion to exercise clinical judgment and erecting barriers that will exacerbate disparities in access to care.

The legislative proposal extends the FDA's ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it, through risk-management plans that would accompany the approval of many new drugs. These "RiskMAPs," as they are called inside the FDA, already guide the use of about 30 marketed drugs as part of "voluntary" arrangements with drug companies.

Right now, pharmaceutical companies propose the plans to better balance the risks and benefits of their drugs, in order to secure FDA approval. But these plans impose burdens, especially on patients who already face difficulty obtaining the specialist care that many RiskMAPs require for the dispensing of new drugs. Thus the FDA and the pharmaceutical industry have mostly confined RiskMAPs to drugs with unpredictable and potentially deadly risks, such as anaphylaxis or rapid organ failure.

That sense of restraint is lifting. New proposals by Congress and the Institute of Medicine advocate RiskMAPs for mitigating a wider set of less-serious problems and to constrain the off-label prescribing of new drugs, even though such prescribing is the standard of care for many diseases. The proposals are gaining traction. Once the FDA is granted the authority to simply impose these RiskMAPs on drug companies, there will be a lot of political pressure on the agency to constrain prescription writing in the name of drug safety.

What would this mean? Consider the RiskMAP recently imposed by the FDA on the use of the diabetes drug Symlin. The new medicine can help very serious diabetics control swings in blood sugar and is one of the few drugs that promote weight loss. But Symlin has a narrow therapeutic margin and can sometimes cause dangerously low blood sugar. The FDA did not trust ordinary generalist doctors -- who treat most diabetics, especially poor or rural patients -- to properly prescribe the medicine or to limit its use to the labeled indication. So Symlin's RiskMAP tries to keep the drug out of generalist hands by, among other things, limiting promotion to doctors specializing in diabetes and who are also supported by certified diabetes educators.

Reflecting this pervasive mistrust of medical practitioners, Medicare is increasingly tying payments to the choices doctors make, compensating doctors more to follow certain cookie-cutter treatments or practice guidelines that are promoted by the agency because they are believed by government experts to maximize benefits or reduce health-care costs.

The Drug Enforcement Administration is also intruding into medical practice. Waging a campaign to cut down on prescription-drug abuse, the DEA has sought legislative authority that would give it a role in limiting the approvals of new pain products -- even though the agency has no ability to appreciate the public health considerations that create a medical need for better drugs to treat serious pain.

Meanwhile, the Department of Justice's war on off-label promotion by drug companies ends up criminalizing the exchange of truthful, non-misleading medical information with doctors on new uses for medicines. This even includes information derived from studies funded by other arms of the government such as the National Institutes of Health. Such was the case in the litigation DOJ recently waged and won against information exchanged on promising new anti-cancer uses for the osteoporosis drug Evista -- some of those uses are now standard care.

All of these approaches harm patients because they impose one-size prescriptions in an area of science that is marked by variation. Furthermore, parameters on the prescription of new drugs, like those imposed on the use of Symlin, create obstacles for patients who already face significant problems getting access to the latest drugs or the specialists who are ordained by FDA's RiskMAPs to prescribe them.

Medicare's treatment guidelines are not the right answer for everyone, because there is a need for judgment in medicine that attunes treatments to individual variations and preferences. DOJ's restrictions on the exchange of medical information deny doctors updated data on the most cutting-edge and specialized uses of new treatments.

Ultimately, we need a better system for accumulating new information about the risks and benefits of treatments, and for communicating this information to providers and patients so people can make more informed choices. The key to improvement is not direct regulation of patient care, but better tools and approaches for evaluating the pros and cons of the many choices patients confront.

Doctors share some blame for inviting this kind of regulation. Agencies have plenty of data showing that some doctors do not heed safety warnings or follow sound advice. Professional societies like the American Medical Association, the various medical journals, and even licensing boards have grown self-interested and have failed the first tenet of an autonomous profession: the ability to regulate itself.

The solutions to any of the health-care problems that government is trying to mitigate will not rest in Washington's constraining "fixes," but with these organs of medicine working with agencies to promote practice standards and safety measures that do not sacrifice medical autonomy and patient choice.

Dr. Gottlieb, who was deputy commissioner of the FDA from 2005 to 2007, is a resident fellow at the American Enterprise Institute.  Read More & Comment...

Kamp Fires

03/06/2007 07:00 AM |

Per my post from yesterday ("Giving EBM the Boot"), our friend John Kamp offers the following:

Why indeed?

As your blog item notes, we better stop "saving" money by restricting formularies and delaying treatment, or there may be fewer lives to save and less money to treat the survivors.

Let me elaborate with one example, Type II diabetes, a condition I follow closely because I have it.

I spent much of the weekend catching up on the new research presented late last year at the World Diabetes Conference in Capetown, South Africia, supporting more aggressive treatment of Type II diabetes.

The research results are exciting. First, earlier and more aggressive treatment will improve blood sugar control and delay the progression of the disease to where becomes ever more difficult to treat and to where complications proliferate. Second, new drugs and new ways to deliver existing drugs provide exciting evolutionary, though not revolutionary, advances. Recently approved and promising new drugs could delay progression of the disease for five to ten years. That could well mean that a 60 year old like me may never go blind, lose a foot, become impotent, require a liver transplant, have a premature heart attack, or face many of the other common complications of this dreaded, deadly disease.

Avoiding these things saves a lot of money in the long run, but requires time, attention and money. Right now -- not a few years from now -- I, my health plan, my doctor and the goverment must focus on more aggressive treatment. That requires pain and money.

For me, it means a significant personal committtment, including:

1. even more aggressive diet and exercise,
2. careful adherence to drug regimines, and
3. giving myself shots of insulin or insulin boosters.

Ouch!

For my doctor, it means education and monitoring much of which is not fully compensated.

Ouch!

For my health care plan and the government, it means spending more money today on treatment and drugs.

Ouch!

For me today's pains are worth the investment. I will work hard with my doctors and my payment partners to keep me healthy and make the investments needed. I will make up any shortfall from the others if needed. I'm fortunate enough to have the means and committment to do so.

Meanwhile, medical policy makers who review this new research must make a similar committment, and lead us to find the means to act on it.

Time is short. We are looking down the barrel of an epidimic of Type II diabetes that may dwarf the personal and social costs of the treatment of things like AIDS and cancer. Unfortunately, denial is the all too common reaction to the social danger of diabetes today.

Right now, medical policy makers must stop denying the cost and trouble of treating Type II diabetes. We must mobilize health care professionals, patients and government, take advantage of existing and developing science, and take a much more aggressive stance.

Denial of treatment at today's pace will mame and kill our bodies and bankrupt our treasuries.

Enough already.

John -- keep those cards and letters coming.  Read More & Comment...

Diving into the Breckenridge Institute

03/05/2007 10:30 AM |

According to Anna Wilde Mathews the Breckenridge Institute, a research and consulting firm in Breckenridge, Colo. said that the FDA "bungled" the ".. effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself."

But who and what is the Breckenridge Institute?

It is run by Mark Bodnarczuk who has written a book called "Diving In." Here's a description from the Institute's website...

http://www.divingin.com/

Set within the cultural context of Bali and Indonesia, the author uses scuba diving metaphors, interwoven with Jungian psychology and the Enneagram to weave a tapestry of complex characters’ lives and to teach fundamental principles of personal growth. DIVING IN penetrates beyond the superficial and obvious to a deeper analysis of relationships, professional satisfaction, and the ways in which people handle conflict in the workplace.

As for the work of the Institute...it uses Breckenridge Institute’s Harnessing Process™ and Breckenridge Culture Indicator™ (BCI™) to affect deep, sustainable, cultural change.


http://www.breckenridgeinstitute.com/

Here's what's on the Institute's web site....

The coral reef harnesses
the invisible power of
the sun and turns it
into a resource
that gives life to
the sea. Your
organization’s
culture is also an
invisible power -
so why not harness it?

Note to Breckenridge: The FDA just had $10 million cut out of it's IT budget. That's invisible. As we say in New York, harness THAT.

Oh, about Enneagrams...those are the nine points or gateways (some say seven points, linked to seven glands) to personality typing that have existed since the dawn of time. (To boldy go where no Institute has gone before..)

If you really need it, here's info on enneagrams from answers.com.

http://www.answers.com/topic/enneagram

Needless to say, Breckenridge is no McKinsey or Accenture.
Which explains why the FDA asked the institute to stay on, for free, to give them a real action plan instead of a lot of New Age speak about changing culture.  Read More & Comment...

A PS to the WSJ BS on PM Surveillance

03/05/2007 10:13 AM |

In the wake of the Grassley Knoll's meltdown over Vioxx (the drug that an FDA advisory committee recommended be returned to market in case anyone noticed) the White House took the $10 million allocated for new FDA IT systems (that would allow the agency to interface with health plans and stop passing the a tin cup to achieve interoperability and develop a common computer code that could be used for spontaneous and real time reporting of drug benefits and risks via electronic health records) was cut and re-allocated to hire additional paper pushers in the agency's Office of Drug Safety.... I have it on good authority that the decision was purely in response to Grassley. So the agency was left scrambling -- during the events described in the WSJ article -- to close a huge gap in its IT budget.

But somehow none of that is relevant. It is easier to piss all over the agency at time when it is under siege and make the hard working people who are seeking to put together a post market IT effort look like idiots. And of course we all know that consultants are the smartest people on the planet...Especially the Breckenridge Institute consultants... But that's the next post..  Read More & Comment...

Money Talks. Rhetoric Walks.

03/05/2007 08:55 AM |

According to a Page One story in the March 3rd edition of The Wall Street Journal, "The Food and Drug Administration has bungled its effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself."

But what is entirely missing from the story (by the generally excellent reporter Anna Mathews) is that the FDA has never been given a budget to build a new system.

Want better adverse event reporting? Want better post-marketing surveillance? Want better data mining opportunities?

Show me the money!  Read More & Comment...

NHS = Now Hiring Security

03/05/2007 08:33 AM |

The NHS (the British National Health Service) is taking the threat of counterfeit drugs seriously. Health officials have warned that patients are being put at risk by counterfeiters targeting the UK's NHS supply chain.

According to Naem Ahmed the head of intelligence at the MHRA (the Medicines and Healthcare Products Regulatory Agency), counterfeiters have become more confident and bolder in their illegal activities. "If you trade over the internet the risk of detection is low, but you only sell a pack here and a pack there. If you penetrate the supply chain, there is a higher risk, but you can make a lot of money."

And the weak link in the chain? Parallel trade.  Read More & Comment...

Giving EBM the Boot

03/05/2007 07:56 AM |

Just returned from Italy where (as a guest of the Bruno Leoni Institute) I spoke in Rome, Genoa, and Milan on the issue of Evidence Based Medicine. Why Italy? Because, as in many other EU nations, the issue of "saving" money by restricting formularies has reached epidemic proportions. Patients are unhappy. Doctors are unhappy. And officials (both elected and career) are frightened -- as they should be after watching what's going in the UK and Germany --that denying health care will, inevitably, become a political hot potato. After all, as one Italian official said to me, "Why should the Heath Minister behave like the junior Finance Minister?"

Why indeed?

Here is how the Italian media reported on both my visit and this urgent transatlantic public health issue:

From Il Giornale:

http://www.ilgiornale.it/a.pic1?ID=161202

And Il Tempo:

http://www.iltempo.it/approfondimenti/index.aspx?id=1146342&Sectionid=8&Editionid=8

And, yes, the food was magnificent.  Read More & Comment...

CBO+EBM=NICE(USA)

03/04/2007 12:22 PM |

Very disturbing article about how the new CBO direct appears to be pulling together a panel to apply evidence based medicine (EBM) and cost-effectiveness measures to decide how to squeeze spending out of the the federal health care budget. In essence he is proposing a CBO version of the the UK's National Institute for Clinical Excellence (NICE) with the added feature that unlike NICE, CBO will be in the business of making both clinical and budgetary decisions....

CBO Forming Panel to Examine Slowing
Health Care Cost Growth, Director Says

The Congressional Budget Office is forming a health care advisory group to help CBO craft options for slowing health care growth, with a first meeting set for May, CBO Director Peter R. Orszag said March 2.

In an interview with BNA reporters and editors, Orszag said the panel would be comprised of health care experts such as visiting fellows who will be charged with helping find options to limit health care cost growth.

Orszag in the past has said the advisory panel would be patterned after the CBO's current panel of economics advisers, and also would aid the agency in improving scoring of complicated health care proposals.

Orszag told BNA that rapidly rising health care spending is the biggest threat to the nation's fiscal health. The advisory group will help produce analytical papers on options for curbing rising spending in ways that will not adversely affect Americans' health, he said.


Rising Costs


"We have to take the cost growth out of health care without harming health," he said.

Rising health care costs are more of a threat to the nation's fiscal health than the expected influx of baby-boomers into federal health care programs such as Medicare, he added.

For example, the panel likely will examine such options as the benefits that health information technology and the comparative effectiveness information on medical procedures could have in slowing cost growth, Orszag said.

Orszag said there is a "substantial amount of evidence" that the health care spending has reached "the flat part of the curve" in which increased health care spending is not necessarily producing increased health care benefits.

Which evidence is that? Added quality of life from new drugs for cancer? Alzheimer's? HIV? New vaccines for HPV?

Orszag said he will spend "a very substantial share of my time helping to bend that curve."

How? By using an arbitrary cut of a 50K for a quality of life year like they do in the UK?

Reducing spending in Medicare and Medicaid likely will only shift costs to other parts of the health care system, doing little to sustain the overall health care system or those federal health care programs, he added.

In a budget options paper released Feb. 23, CBO put forward numerous options for trimming federal health care spending. For example, the report said paying Medicare managed care plans the same rate as fee-for-service plans could save $65 billion over five years.

Meaning, we can cut risk adjusted payments for the sickest seniors that are designed to treat them and keep them healthy and integrate their care....

I can't wait to see how many of the panel from from the left wing funded Prescription Project or IMAP. Any bets that Jerry Avorn, supporter of ALLHAT (the modern day Tuskegee experiment) will be annointed?  Read More & Comment...