Latest Drugwonks' Blog

Here’s Bob Goldberg’s perspective on another aspect of Marc Kaufman’s article …

So typical of the lazy and unsystematic thinking that plagues health care reporting in general. Worrying about generic drug backlog because it’s one of the few ways to reduce “skyrocketing” health care costs” (Actually, health care costs have been slowing in recent years but whose counting. Increased use of medicines is attributed by many scholars — i.e., not journalists — for the slowdown because use of medicines postpones or offsets utilization of surgery, nursing homes, etc.)

Now, how about the delay in the cervical cancer and rotavirus vaccines? The delay in the Alzheimer’s vaccine? The 10-year lag in figuring out that Herceptin should be used in early stage breast cancer because all the trial designs are geared to show maximum benefit from a frequentist statistical standpoint that has no reference to real world use? Taken together these products and uses alone would make the “savings” of the 800 generic medicines waiting at FDA seem a pittance. Has Kaufman ever done a piece on the need or effort to transform the FDA to accelerate the development of real health care solutions. No. You can look it up.

It’s another example of how the MSM fails to get the connection between health care costs and technology: the price of new technologies that are based on a geniune understanding of disease mechanisms and individual responses to treatment are cheap relative to the cost of managing the same illnesses with halfway or no tech approaches. Put another way: what is cheaper, what is more cost-effective: using generic versions of today’s drugs as part of the effort to treat more cases Alzheimer’s, cancer, stroke, diabetes using our current know-how, or treatments that actually prevent or stop these diseases before they develop?

Why do policymakers, pundits and journalists see the efforts and investments of companies pursuing these high tech solutions are evil but see the accelerated development of knock-offs as holy?

Generic Response

  • 02.04.2006

In The Washington Post, Marc Kaufman reports that the FDA has a backlog of more than 800 applications to bring new generic products to the market — an all-time high.

FDA, however, has told Congress that the office that reviews new generics needs no additional money, and the agency has no plans to hire more reviewers. “We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog,” said Gary Buehler, director of the agency’s Office of Generic Drugs.

That generic response is completely unacceptable. The Office of Generic Drugs needs more reviewers and that means it needs more money.

The days of saying “we can do more with less” are over at the FDA. Today, unfortunately, it’s about doing less with less. That is not acceptable.

The generics office’s budget was about $26 million last year. In response to questions from Congress, the agency said the generics program would have to make cuts in 2006 to offset pay raises. Gary Buehler said he expects a record number of applications this year — and an even larger backlog — because “we don’t believe we’ll be getting any staff increases in 2006.” Buehler said his office received an all-time monthly high of 129 applications in December.

And he says he doesn’t need any more money?

“This huge backlog of generic applications is just unacceptable,” said Rep. Henry A. Waxman, one of the sponsors of the law that made generics more easily available two decades ago. “This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind.”

I never thought I’d be saying this, but Mr. Waxman is 100% right. But talk is cheap. The question is, what’s he going to do about it?

Henry — show me the money.

Some at the agency and in the industry say the answer is to have generic-drug makers do what brand-name makers did in the early 1990s — pay user fees to finance new hires by the FDA.

Considering the huge profits enjoyed by the generic drug industry, I think this is certainly something to consider.

Hillary's Plan B

  • 02.03.2006

Plan “B” for “Bob” (Goldberg) …

Fresh from rolling her eyes at the President at the SOTU, Hillary Clinton took direct aim at CMS director Mark McClellan about the what the media has now deemed “the troubled” Medicare prescription drug plan. In full campaign mode, Mrs. Clinton told Dr. McClellan during a hearing “I, for one, believe we should scrap this and start over.”

With what? Hillary didn’t say. But she’s still proud of her record so we can assume that Plan B is Hillarycare Redux. Indeed, after trashing McClellan she took the opportunity to take credit for drug prices going down when she was running the health care show. “We weren’t successful getting the legislation passed, but we were successful sending a message that people better get their prices down,” she said.

Maybe. But back then the market value of biotech stocks also went down. So too did the amount of venture capital flowing into start-ups. Indeed, the amount of money going into biotech declined more sharply when Hillary was threatening price controls than at any other time since biotech has been around. A survey of biotech firms at the time and found that 75 percent of them had 2 years of cash or left in large part because, as the head of the biotech trade group BIO testified at the time “1993 difficult year because in large part investors were scared by the de facto price controls in the Administration’s health care plan. They feared that some widely discussed points of health care reform would mean that they would not recoup their investment in a company that was close to bringing a product to market. According to many press accounts and three BIO surveys of our companies developing therapies for AIDS, cancer, and other deadly and costly diseases, our companies are cutting back on research.”

And the price controls she DID get passed in the Vaccines for Children Program were cited by the Institute of Medicine in 2001 as one reason the vaccine industry is stagnant and unprofitable. Who wants to invest in products knowing your prices are going to be frozen for a decade?

Then there’s Children’s Health Care Insurance Plan she loves to take credit for. This program provides federal money to set up state run low cost insurance programs for working class kids. It was supposed to insure nearly 9 million children. Guess what? Under her stewardship kids were first dumped from Medicaid and then re-enrolled into SCHIP programs. And then it took 4 years to enroll 3 million children. And at the same time, private companies dumped coverage for kids and many parents simply stopped insuring their kids at all.

This page will be more than happy to help Mrs. Clinton promote her health care ideas. Sunshine is the best disinfectant.

Moore is Less

  • 02.03.2006

Here’s an e-mail that Michael Moore is sending around. (I’ve only included snippets — but you’ll get the idea.) It’s just another high profile example of the Propaganda of Fear, of finding horror stories and packaging them to look like the everyman status quo. The epitome of the one-sided argument. If this project ever sees the light of day, it will have an impact on some of our political leaders — because it’s precisely the kind of drivel they want to hear. It’s the 21st century version of bread and circuses.

That being said, it’s time that we begin our own crusade of good news, of communicating, through truth and hope, the miracles of modern medicine. We must fight the Propaganda of Fear with the Four Horsemen of Conviction, Confidence, Truth and Hope.

Here’s the less from Moore …

Have you ever found yourself getting ready to file for bankruptcy because you can’t pay your kid’s hospital bill, and then you say to yourself, “Boy, I sure would like to be in Michael Moore’s health care movie!”?

Or, after being turned down for the third time by your HMO for an operation they should be paying for, do you ever think to yourself, “Now THIS travesty should be in that ‘Sicko”movie!”?

Or maybe you’ve just been told that your father is going to have to just, well, die because he can” afford the drugs he needs to get better — and it’s then that you say, “Damn, what did I do with Michael Moore’s home number?”!

Send me a short, factual account of what has happened to you — and what IS happening to you right now if you have been unable to get the health care you need. Send it to I will read every single one of them (even if I can’t respond to or help everyone, I will be able to bring to light a few of your stories).

Thank you in advance for sharing them with me and trusting me to try and do something about a very corrupt system that simply has to go.

It’s time that we, the voices of reason and sanity and hope go on the offensive against people like this who, just to turn a buck, will ravage just about anything — including the miracles of modern medicine. Mr. Moore isn’t interested in making things better — but he’s sure interested in making money — the same charges he’s leveling against those in the crosshairs of his camera lens.

Long-term thinking at long last in European health policy? Maybe.

European governments seem to be swapping a bludgeon for a scalpel when it comes to cutting the cost of medicines. According to Reuters, drug makers should not expect an end to the overall drive to squeeze prices but there are signs of a more discriminating approach that may actually help “big pharma”, according to industry executives and analysts. Andrew Witty, head of European pharmaceuticals at GlaxoSmithKline Plc said a growing number of governments are now realizing that healthcare reforms must include rewards for innovation.

“There are still a few governments that are very focused on short-term, non-discriminatory cost measures, where they simply cut prices and they donç©° really care if it is an innovative product or an old one, but they are getting fewer,” he told Reuters. ‘There are more and more countries where we are seeing governments get much tougher on the prices of old, off-patent medicines and being prepared to reward meaningful innovation more quickly and more fully.” For companies like Glaxo, which relies heavily on sales of newer drugs, that is good news.

European pharmaceuticals growth is hovering around a 10-year low with sales in the top five markets — Germany, France, Britain, Italy and Spain — rising just 3% in the 12 months to November, according to IMS Health. Yet Merrill Lynch believes the worst effects of European pricing reforms may now be over, with Germany in particular showing signs of recovery. Growth in German pharmaceuticals has picked up to 7%, from 1% in 2004, largely as a result of a cut in mandatory manufacturer rebates to the government, the investment bank said in a report this month.

Spam, MD

  • 02.01.2006

Here’s an unsolicited e-mail that I got today …

Dear Peter Pitts:

It’s a well-known fact that Consumer Reports provides expert advice
and unbiased information and Ratings. Each year, we report on
thousands of products — everything from cars to computers, tires
to treadmills.

But did you know … we also offer independent, trustworthy medical
advice and top treatment Ratings for over 100 common conditions,
including back pain, obesity, ADD, and breast cancer, among
many others?

INTRODUCING … Consumer Reports

This new, interactive Web site will empower you to take charge of
your healthcare. The assessments and ratings it provides are based on
the best evidence from clinical reports from around the world, in
partnership with the British Medical Journal. And because we don’t
accept advertising, not from drug companies or from insurers, we are
free to say what works, and more importantly, what doesn’t.

So, whether you’re researching an existing medical condition or
wondering what drugs adversely interact with your new prescription,
Consumer Reports has the answers.

I will not be subscribing to this marvelous opportunity. You can draw your own conclusions.

Vet-ing Clinton

  • 01.31.2006

Paul Krugman wrote an op-ed singing the praises of what he calls the socialistic health care system of the Department of Veterans Affairs. He was taking a page from a speech given by Hillary Clinton the week previous to his editorial in which she outlines a new vision of Clintoncare where government still runs the show but uses electronic patient records, price controls and government drug lists to make medicine more efficient. The following lengthy deconstruction by Bob Goldberg is must reading for anyone who wants to fully understand the manner in which Mrs. Clinton and others shround their effort to nationalize health care with deliberately misconstrued interpetations of obscure research publications they know journalists are too hurried to track down and seemingly erudite (but misinformed) discussions of the impact that market forces and medical technology have on the American health care system.

Here’s the link:

Download file

Calfee Talk

  • 01.30.2006

Here is a link to an important perspective on the FDA’s new physician labeling rule. It’s penned by AEI scholar and CMPI advisory board member Jack Calfee.

Download file

Big news that will surely generate big controvery …

The New York Times and other media report that the European Union’s drug regulator recommended approval on Friday of a generic version of a growth hormone, a step forward in attempts to get approval for copies of biotech drugs.

Regulators in the European Union and the United States have not yet approved any so-called biosimilar medicines amid fears over safety and pressure from makers of patented biotech drugs. One big concern is that biotech drugs, unlike traditional chemical compounds, are too complex to copy easily and safely.

The European Medicines Agency said that studies on Omnitrope, a growth hormone made by Sandoz, the generic arm of Novartis, showed comparable quality, safety and efficacy to Genotropin, a Pfizer drug already approved in Europe. The decision should pave the way for the European Commission, the European Union’s executive arm, to give formal approval to Omnitrope within a few months.

Europe issued guidelines for biosimilar medicines in 2004, laying out the steps needed for regulatory approval. That has made it easier to file than in 2003, when the European Commission declined to approve Omnitrope, said Andreas Rummelt, chief executive of Sandoz.

Oops. I made a mistake in yesterday’s blog entry (“Lack of Evidence-Based Accusations”). I referred to Dr. David J. Rothman as President of the Institute of Medicine. He is, in fact, President of the Institute on Medicine as a Profession. I have to admit that my initial reference came directly from the New York Times article on the JAMA editorial. (And I should know better than to take whatever appears in the New York Times as entirely fact-checked.) Mea culpa. (It’s like they say, everything you read in the paper is true, except for those things you know about personally.) What I find most interesting about this correction is that Dr. David Rothman isn’t even an MD — but he sure has strong opinions about who should be visiting their offices.

I also want to clarify my statement about the JAMA article’s lack of evidence. There certainly are plenty of citations — but not a jot about patient outcomes. How trivial! Further, the authors of the article view the visits of pharmaceutical sales reps as the only variable on a physician’s prescribing behavior. What about formulary restrictions? Or payment incentives? Or counter-detailing efforts, tiered co-pays or payor-switching? Details. Details. Details.

The concept that big, bad Pharma is to blame for everything isn’t just simplistic and sophistic but deleterious to a serious conversation about the issue. Rather than trying to point a finger, the authors should pick up a mirror.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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