Is Leonard Saltz of Sloan Memorial more interested in attacking drug companies or caring for patients...Rather than pushing insurance companies to cover new cancer drugs, Saltz has devoted time decrying the price of new medications. And now he has taken his ideologically driven campaign to a new low, scaring patients into choosing a treatment based on price. In doing so, Saltz provides an example that even someone with no background in oncology should find shocking and a signal to stay away from Saltz as a treating physician: (From the Pharmamarket Newsletter)

"One example given was for metastatic colon cancer, where the price differential is $60,000 for a treatment course, depending on which of two drugs a patient is prescribed. According to Leonard Saltz of the Memorial Sloan-Kettering Cancer Center, the cheaper generic drug, irinotecan (previously marketed as Campto/Camptosar), causes hair loss. However, he adds that the more expensive agent, Sanofi-Aventis' Eloxatin (oxaliplatin), can cause nerve damage to hands or feet. Depending on one's professional occupation one or the other drug might be easier to accommodate. However, in cases where a patient is concerned about using up savings that might otherwise be left to dependents, the ASCO guidelines are intended to allow for an informed choice with the assistance of a specialist.
Dr Saltz argues that the logical result of such a change in approach must be to have more price transparency, at least so that specialists are able to provide patients with the necessary data."


Where to begin? How about that the two drugs are used in combination in many cases. Or that pharmacogenetics suggests one drug is better than the other. Or clinical trials suggesting longer survival with Eloxatin? Does Lenny Saltz suggest making that information transparent.

Or how about making this information transparent instead of scaring people about prices:

"Since 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual drugmakers has approached the problem by matching nearly five million patients with free drugs in cases where there is an inability to pay (Marketletters passim). "


I will talk Saltz seriously when he speaks out strongly against huge cancer drug co-pays, particularly when genetic tests indicate a drug works....Until then, I would avoid him, both as a source of policy advice and cancer care.

Why even bother having an FDA reporter when writing an FDA “expose” story is as easy as, well, Mad Libs.

New Report by (proper noun) Accuses FDA of (adjective) Oversight

Today (adjective) Citizens for (adjective) Health, a not-for-profit organization, released a (adjective) meta-analysis that (adverb) concludes the FDA, “is in the (noun) of (adjective) Pharma.”

“Our research of (number) concerned (plural noun) points (adverb) to an agency that has once again (verb past tense) the American public. It’s a (adjective) indication that the FDA places (noun) over (noun) and cannot be trusted to (verb) or (verb) – and certainly not (verb) in the public interest,” said the author’s report Dr. Sidney (type of animal).

“I find this new report both (adjective) and (adjective) – but (adverb) not (adjective),” commented Representative Henry (proper name).” “And I intend to hold televised (plural noun) on the matter.”

“This is just another (adjective) example of the FDA’s lack of (adjective) (noun), added Dr. Steven (name of automobile company). If I were the FDA Commissioner this (adjective) circumstance would never have occurred.”

In an embargoed editorial, the New (place name) Journal of Medicine opined that the (adjective) problem “is caused by the Prescription (noun) User-Fee Act and made even (adjective) by the agency’s continued (verb) of direct to (noun) advertising.” The editorial also points to the need for (adjective) importation of prescription (plural noun) from (name of country).

Supporting this notion, the AAR(letter) added that (adverb) high (plural noun) for drugs are a result of the (type of shrub) Administration's (adjective) program known as Part (letter) and supports (adjective) government (verb).

The FDA had (adjective) comment.

Jerry Avorn ran a statistical analysis in the NEJM showing that there were more black box warnings and discontinuations after PDUFA than before.

If he is trying to show that PDUFA means unsafe drugs he is making a logical leap not supported by his numbers crunching. Increased black box warnings are a result of greater vigilance and post-market review. And lumping discontinuations with black boxes is a slick statistical trick to mask the fact that product removals as a percent of all new molecular entities has remained fairly stable at 2-3 percent for decades and after PDUFA. Ask the FDA.

Meanwhile Janet Woodcock underscores what is really at the heart of the current slowdown in drug approvals and greater scrutiny: we know more and understand more. And often companies dump too much data on the FDA that is not informed by what we know but by what companies thinks the agency wants.

On the other hand, what explains the fact that some important medicines have received European approval even as they languish at the FDA? To be sure, Europe has often approved new drugs first and faster. However it is hard not to believe that having Grassley, Waxman, Stupak looking to turn new drug into a new scandal is slowing things down....

The Critical Path should lead to more science-based and population specific standards. But don't expect Avorn or any FDA commissioner wannabe to be satisfied...

http://www.ft.com/cms/s/0/7ae3646a-fad6-11dc-aa46-000077b07658.html?nclick_check=1

http://online.wsj.com/article/SB120648160360663519.html?mod=googlenews_wsj

Our regulatory cousins to the north have begun the process of creating a biosimilar regulatory framework.

Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics” once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.

Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product.

The best part of the ODAC meeting was when the committee as a whole dismissed Richard Padzur question -- designed to prop up an increasingly suspect coverage decision by CM -- asking to slap a one-size fits all dosing limit on ESAs. To quote one panelists: "This is silliness." Other comments could be characterized as dismissive.

In general the panel appeared perturbed that the FDA essentially did not provide it with either an objective or complete picture of the overall risks and benefits of ESA use in chemotherapy. The same goes with Padzur's lame attempt to misconstrue his negative opinion of the nature of quality of life data because most of it is observational study as the final word on the subject. He fooled the media who failed to look deeply into the data but not practicing oncologists on the panel.

Of course the media had all but predicted the demise of ESAs and is treating the ODAC decision as some sort of upset. Read the CNN.com piece below. You can just feel the shock and disappointment....Ultimately companies and doctors will have to work together to come up with more patient-centric data on who the drugs work for. If they had done this in the first place, the generalized concerns about safety could have been mitigated. Let's hope they do so going forward.

The committee did the right thing by swatting away Padzur's thinly veiled attemtp to manipulate them into affirming CMS' wrongheaded coverage decision. It did the right thing by giving doctors flexibility and recommending limiting use in areas where no benefit seems to exist.

http://money.cnn.com/2008/03/13/news/companies/amgen/?postversion=2008031316

The House Energy and Commerce Committee's health subcommittee is scheduled to pick up Tuesday where it left off Thursday, discussing and possibly amending the tobacco-control legislation before certain passage. The full committee would then take up the bill, and passage there appears certain as well.

Then it's on to the House, where a bit more than half its members (220, to be precise) are co-sponsors of the bill. In the Senate, similar legislation has 56 co-sponsors – including Senators McCain, Clinton, and Obama.

Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.

One major problem with the proposed legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.

Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. If FDA became the nation's tobacco czar, it would become difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.

Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself if this is really the way we want to be going.

So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.

So for now, thank you for not regulating.

FYI -- the Center for Medicine in the Public Interest (the sponsor of drugwonks.com) does not accept funding from the tobacco industry.

On the heels of my article discussing McCain's market-driven views on health comes his statement to the effect that credible scientists believe that vaccines cause autism.

I think McCain is misinformed and was responding to a question from a parent with autism who really believes in this crap.

If he clarifies on the basis of sound science it will be a one day story. If not, as the folks at http://overlawyered.com note, he will have stepped in it big time:

"The Republican candidate sticks his foot in it in a major way on a topic extensively covered here over the years (as well as at my other site). Writes Mark Kleiman: "the thimerosal-autism theory is as dead as phlogiston in respectable company. I'm not surprised that 'respectable company' excludes a few ambulance-chasing lawyers looking for deep pockets and a some emotionally devastated parents looking for someone to blame. But it's distressing — to use no stronger term — that the presumptive Republican nominee for President, rather than looking at the evidence, has chosen to side with the panic-spreaders and pander to the emotions of the panic victims."

My take. This was a well-meaning but less than informed statement. McCain is not the first Senator to know little about the complexities of this issue. Let's give the guy a couple of days to actually look at the evidence instead of being force fed foolishness from Dan Burton.

And PS. Autism cases have NOT increase as the Senator stated. Reclassification explains the surge in incidence and prevalence.

According to an article in the Connecticut Post:

"The federal government has a role in helping jump start the economy in the Naugatuck Valley, but much of that initiative needs to be done through a public/private partnership, U.S. Rep. Rosa DeLauro, D-3, told members of the Valley Chamber of Commerce this morning."

Representative DeLauro -- how about some support for another public/private partnership, one will help jump start 21st century health care -- the Reagan/Udall Foundation.

In the recent on-line version of Health Despair there were two reports that seemed to send the same old messages: more folks unable to pay for increasingly expensive health care premiums. As Boomers move into Medicare, the cost will be unsustainable.

Wrong on both counts.



The U.S. Economy And Changes In Health Insurance Coverage, 2000-2006
John Holahan * Allison Cook insists the eroding insurance coverage is a matter of eroding wages and rising premiums.

Not so simple. Insurance coverage increased for kids and when you back out illegal immigrants the number is of uninsured kids is even lower. (I thought there was a SCHIP crisis!)


During the 2000-2004 period studied, the greatest percentage increase in adult uninsurance was among rich and middle class folks. 3.4 million increase in uninsured adults and children between 2004 and 2006, 700,000 were middle-income Americans and 800,000 were higher-income Americans. The authors fail to point out that there was an increase in people receiving coverage in the private market from 2004-2006 which is about the time HSAs began to expand. All other categories of coverage experience a decline. Except government coverage.

http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.2.w135v1

Turning to the growth in medical spending in the article: Health Spending Projections
Through 2017: The Baby-Boom Generation Is Coming To Medicare

The article states: "The primary drivers of personal health care spending growth during the projection period are medical prices and utilization, followed by smaller impacts from population growth and the age-sex mix."

Gee, I thought it was disease.

"As a result, health is projected to consume an expanding share of the economy, which means that policymakers, insurers, and the public will face increasingly difficult decisions about the way health care is delivered and paid for."

But what about technologies that reduce the burden of disease even as they increase life expectancy? Here's what another article in Health Affairs noted:

"A sixty-five-year-old with a serious chronic illness spends $1,000-$2,000 more per year on health care than a similar adult without the condition. However, cumulative Medicare payments are only modestly higher for the chronically ill because of their shorter life expectancy."
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.r18

There are signals all over the place that our health care system has reached a tipping point on its own, pushed by consumers, mainly boomers, towards prevention, value, personalized care. The point would be to unleash this power by giving this generation and the next more control over the course of their health and care. Why not reward people for staying healthier, longer? Yet we are setting up a regulatory and reimbursement system that discourages such advances.

The closer we move to prevention and prediction, the more valuable health care becomes. The more we spend on more effective care the better off we are. If we spend 30 percent of out GDP on such things, isn't that better than spending 30 percent of it on services and technologies like heart and lung machines, drugs that only work half the time in half the people? Yet that is exactly where the command and control models of European, Canadian and Medicare want to take us.

Interesting omnibus piece from by Warren Ross of Medical Marketing & Media on the various slings and arrows being tossed at the worlds premier medical regulatory agency.

Here’s the first paragraph:

The FDA seems to be under fire from all sides these days, with everyone from drug industry pooh bahs to would-be watchdogs nipping at its heels. The agency, some charge, is going slow on approvals due to a risk-averse culture deepened through the experience of Vioxx and other product safety crises. Resignations are up, morale is down and the put-upon bureaucrats are laying low, the story goes. Others complain that reviewers are subject to political and corporate pressure through PDUFA and a nefarious web of relationships.

And here’s a link to the complete article:

http://www.mmm-online.com/Whats-Up-with-the-FDA/article/104861/

Here’s what I had to say about the David Grahmatization of the whistleblower culture:

Pitts also takes a dim view of people who go outside the agency to complain. A professional, he maintains, should not “weep and whine and try to get decisions made that are based on politics rather than on science.” Whistleblowers, he acknowledges, at least deserve “grudging respect” for letting it be known who they are, “but what is truly damaging are the silent leakers” who try to force political pressure on FDA decisions. “The motive may be either to get drugs approved or not approved—it cuts both ways.”

As Jimmy Durante said, “I’m surrounded by assassins.”