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...

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...