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During my tenure at the FDA I was the senior official in charge of advisory committees. I was proud to oversee a transparent, collegial, and scientific program crucial to the agency’s mission of protecting and advancing the public health.

Today I am upset and worried about the future of this process.

In the wake of FDA bashing for political and personal gain, the advisory committee process is spinning out of control. Witness yesterday’s unexpected chest thumping by members of the Drug Safety and Risk Management advisory committee

The panel voted 8 to 7 to propose a ‘black box’ warning for methylphenidate drugs, sold under the brand names Ritalin, Concerta, Methylin and Metadate, and on the amphetamines Adderall and Adderall XR, stimulants used to treat attention deficit hyperactivity disorder. The warnings could be rescinded if future studies fail to definitely establish any risk.

But the harm to physicians (worried about law suits) and parents (worried about their children), and the children (who aren’t being appropriately treated) would have already happened. What makes this so very frustrating is that the committee didn’t make its recommendation for a black box based on the available data, members of the board said the recommendation was driven as much by worries that the drugs are being overused in the United States as by the possible side effects.

The FDA advisory committee process in the Age of Grassley seems to be “Science? We don’t need no stinking science.”

And even more frightening is Precautionary Principle creep.

According to the Associated Press, “The surprise recommendation has caught the Food and Drug Administration off guard.”

To say the least.

“You don’t want to overscare people with data that aren’t very solid,” said Robert Temple, director of the FDA’s office of medical policy. He said the drugs carry real benefit for some patients. Before the committee’s vote, Thomas Laughren, who heads the FDA’s division of psychiatric drugs, told the committee he didn’t “think we are there yet with this cardiovascular risk” in terms of justifying a black box.

Science? We don’t need no stinking science.

Here’s a headline from a story by Marla Cone in today’s Los Angeles Times …

“Mercury readings high in state.”

Here’s the lead paragraph:

“Californians have among the worst mercury contamination in the nation, with nearly one-third of those volunteering in a nationwide study exceeding the concentration of the potent neurotoxin deemed safe, according to a study organized by two national environmental groups.”

Here’s the 10th paragraph (of an 11 paragraph story):

“The new study, which is ongoing, is the largest test of mercury exposure in the nation. But the results are not statistically representative of the United States because participants were self-selected volunteers. They joined the study by visiting the Greenpeace or Sierra Club Web sites and sending $25 with each hair sample.”

Sloppy, slanted, spurious reporting.
Please pass the tuna.

I’m sure that Senator Charles Grassley and others who think the FDA should view the pharmaceutical industry in a strictly one-dimensional adversarial fashion will be upset to learn that collegial two-way communications is — gasp — good for the public health.

According to a new report, new medicines reach the U.S. market sooner when regulators meet with drug makers before the final phase of human testing and made sure they were addressing potential pitfalls. The report, by consulting firm Booz Allen Hamilton (undertaken at the request of the FDA), said fifty-two percent of manufacturers that consulted the Food and Drug Administration at that time won approval after an initial review, according to an analysis of 77 drug applications submitted from 2002 to 2004. Only 29 percent of companies that did not have such meetings received clearance for their products during the original cycle. (Medicines that fail to win FDA clearance after the original review of typically six to 10 months may go through multiple evaluations before reaching the market.)

A top FDA official said the agency agreed the early meetings with drug makers were productive but said more staff would be needed if the number increased substantially. (This is code for “we need more money!”)

“We have seen a pretty dramatic growth in the number of meetings we’re having with sponsors in the past several years. Any additional workload for meetings is going to have to be supported by additional staffing,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs.

“Early and open communication with the sponsors will allow sponsors to address/resolve issues in a timely manner, potentially within the first review cycle,” the report said.

Once more with feeling everybody, let’s do the budget season chant — “Show me the money!”

Dr. Bob Goldberg pulls no punches in response to Stephanie Saul’s article (“Record Sales of Sleeping Pills Are Causing Worries”) in today’s edition of the New York Times …

Stephanie Saul fits the mold of NY Times reporting on the drug industry like a glove: Big bad companies market lifestyle meds with horrible side effects when simple changes in how we live could easily take care of the problem. Instead of marketing erectile dysfunction drugs, the drug companies are pushing sleeping pills of all things.

Here’s the crux of her article, “… some experts worry that the drugs are being oversubscribed without enough regard to known, if rare, side effects or the implications of long-term use. And they fear doctors may be ignoring other conditions, like depression, that might be the cause of sleeplessness.”

Rare side effects and implications of long-term use? What are the side effects? Sleepiness? That is fairly standard and well known. How do we know they are being over “subscribed?” Saul gives us no benchmark since there is nothing in the article about the extent of sleeping disorders in the United States. Along those line, her claim that experts fear doctors are ignoring related conditions flies in the face of a campaign to make doctors aware that sleep disorders are a component of other illnesses. If she had done a little research, just five minutes of Googling, she could have found that out.

But she doesn’t give us context because Saul wants us to believe sleeplessness was a problem invented by drug companies to sell a useless product. Has she read anything about the increased risk for stroke and sleep apnea? What about the studies reporting up to 80 percent of people on dialysis suffer from insomnia? The fact that most primary care doctors have failed to treat sleeping disorders among people suffering from mental illness, arthritis and fibromyalgia?

A good article would have provided context, history, risks and benefits. As it stands, it is another example of the rotting standards of medical journalism that dwells on the fear factor.

FDA released its Fiscal Year 2007 budget request to Congress totaling $1.95 billion, a 3.8 percent increase over FY 2006.

Nearly $6,000,000 ($5,940,000 to be precise) is new funding for the Critical Path Initiative. This is the first time Critical Path funding has been included in the Administration’s proposed budget.

It’s money well spent and I certainly hope members of Congress embrace this as an important initial investment in the future of American health care.

An initial investment.

In a notice posted on the FDA’s Web site Friday, the agency said it is seeking comments on a proposed study that would examine whether coupons and rebates that are part of some prescription-drug advertisements might cause consumers to think a drug is safer or more effective than it really is. The agency said the study is part of an effort to get “empirical data about consumers’ perceptions” of coupons and how a particular product might be viewed. The agency said information from the study would be used “to justify future regulatory changes.” “Coupons and price promotions may imply superior drug efficacy,” the FDA said.

Well, here’s a cost-saving tip to my buds at DDMAC — coupons do, in fact, attract people to a product. That’s why they’re used. Whether or not an ethical product should coupon is certainly an interesting philosophical question.

But it is in no way a regulatory one.

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 michael@michaelmoore.com. 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.

CMPI

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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