July 22, 2008

Fellowship-shape

by Peter Pitts

The FDA said last Thursday it will launch a two-year fellowship program for physicians, chemists, statisticians and other science professionals interested in food and drug regulation. About 30 to 40 fellows will be accepted for the first program, which begins in October. Some of those accepted are expected to stay on as full-time employees after completing the program, which includes course work and seminars.

This is crucial since the average age of the FDA's work force is 54, and about 30 percent of general staffers already are eligible to retire.

That’s why “a strong FDA” is part of the agency’s five year strategic plan.

FDA’s most proprietary and valuable resource comes through the door each morning. There are almost 1,500 people with PhDs at FDA and well over 400 with medical degrees – and that’s without double counting.

An organization that can keep up with the rapid changes in the industries that it regulates, and that is capable of developing and implementing effective and innovative public health measures, requires a very special workforce. The FDA’s mission depends more than ever on a solid cadre of experienced physicians, toxicologists, chemists, statisticians, mathematicians and other highly qualified and dedicated professionals. Their expertise is essential for making regulatory decisions that are balanced and fair and timely -- and for keeping the agency on the cutting edge of the technology and sciences used by industry.

Agency leadership must make it a priority to encourage creativity, efficiency, and superior performance - an environment that attracts and retains top-quality scientists, and enables them to do top-quality work as part of an effective team.

Posted by peterpitts at 09:04 AM
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April 10, 2008

FDA Addresses Tort(i) Reform

by Peter Pitts

Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. announced the appointment of Frank M. Torti, M.D., M.P.H. as the FDA's Principal Deputy Commissioner and first Chief Scientist.

The newly created Chief Scientist position stems from the Food and Drug Administration Amendments Act of 2007.

"Dr. Torti's impressive clinical and scientific credentials are an excellent match for the work we do on a daily basis to promote and protect the nation's health as a science-based and science-led agency," said Dr. von Eschenbach. "FDA's Chief Scientist will ensure that the foundation of the FDA's regulatory structure will always be state-of-the-art science."

As Chief Scientist and a member of the agency's senior leadership team, Dr. Torti will support the launch of the FDA Fellowship Program, which has the potential to attract up to 2,000 professionals of varying disciplines for a two year training program. As well, the new office will work to ensure the quality and regulatory focus of the intramural research programs of the agency, and place special emphasis on the importance of clinical research trials that are a part of the foundation of the FDA's regulatory structure.

“I appreciate the confidence and trust that Secretary Leavitt and Commissioner von Eschenbach have placed in me," said Dr. Torti. “I look forward to beginning this work at this important moment for the FDA."

A prominent clinician, scientist and researcher in molecular oncology, Dr. Torti is currently serving as Charles L. Spurr Professor of Medicine, Chair of the Department of Cancer Biology, and Director of the Comprehensive Cancer Center at Wake Forest University School of Medicine in Winston-Salem, N.C.

Dr. Torti received his bachelor's and master's from Johns Hopkins University, his medical degree from Harvard Medical School, and his Master of Public Health from Harvard School of Public Health. He served as an intern and resident at Beth Israel Hospital in Boston, and a fellow of medical oncology at Stanford University where he subsequently joined the faculty and was tenured. He has written extensively on prostate and bladder cancer, designed and executed a number of cancer clinical trials, and has substantially contributed to the understanding of the molecular mechanisms that underlie inflammatory diseases and cancer.

Throughout his career, Dr. Torti has served on and chaired a number of national health and medical committees. He currently serves on the National Institutes of Health's National Advisory Council for Complementary and Alternative Medicine. He also founded and serves as President of the Cancer Biology Training Consortium, a national society of cancer biology department chairs and program directors. He is the recipient of a National Institutes of Health MERIT Award.

Dr. Torti will join the FDA in May.

Posted by peterpitts at 08:02 AM
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March 18, 2008

Caught in in FDA's Web

by Peter Pitts

FDA's new website that is.

Check it out at http://www.fda.gov

Posted by peterpitts at 04:43 PM
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March 03, 2008

Embed with the FDA

by Peter Pitts

Some comments from the glamorous Gaithersburg Hilton and the inaugural meeting of the FDA's Risk Communications Advisory Committee.

Star of the meeting was FDA Commissioner von Eschenbach.

Andy pointed out that the committee's work was "central and core" to the mission of the FDA -- specifically because it speaks to how the FDA crafts messages for the general public. And to that end the Commissioner commented that the FDA has to learn "not only what is the right thing to do -- but how to do it the right way."

The Commissioner spent much of his remarks on the general theme of "putting things into the proper context for the patient," pointing out that "trust is built on communication and dialogue." And he acknowledged that this meeting is taking place "at a time when there is an erosion of consumer trust in the FDA."

Sometimes stating the obvious is the best place to start. Confession, after all, is good for the soul.

"Help us dialogue," the Commissioner asked the committee.

Communications hint to Commissioner: "Dialogue" is not a verb.

To that end he shared that he has floated the idea of "embedded" reporters at the FDA -- and shared that the concept "sent shudders" throughout the agency.

He addressed the need to better balance risk communications so as to avoid unintended consequences, specifically the need to better consider the desire to communicate earlier versus communicating with less evidence and certainty.

Andy also announced that the FDA world shortly announce more details on the Sentinel Network on post-market surveillance. That's good news and long overdue.

The Commissioner also staked a claim to FDA's leadership in educating the American public to what he called "the doctrine of risk," calling for a national dialogue.

Amen again-- and God's Speed.

Posted by peterpitts at 08:21 AM
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February 22, 2008

Not the real FDA – a Grahamatization

by Peter Pitts

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.

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.”

Posted by peterpitts at 08:07 AM
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February 13, 2008

Step Up to Debar

by Peter Pitts

According to the Pink Sheet:

"The integrity of FDA's drug approval process is being undermined by the agency's failure to actively and consistently prohibit participation by companies and individuals previously convicted of crimes associated with drug approval, the House Energy and Commerce Committee's minority staff concludes in a report released Feb. 11 by Rep. Joe Barton, R-Texas."

Does Mr. Barton have any evidence that folks who should have been disbarred haven't been? Does a lack of disbarments equal a lack of enforcement?

"FDA's debarment authority comes from the Generic Drug Enforcement Act of 1992, which was enacted in response to the generic drug scandal of the late 1980s. It allows debarment of generic drug companies, but FDA has failed to take action against even one firm, the report says."

"The report also notes deficiencies in the law and suggests FDA be given authority to debar brand-name and biologics companies, as well as those that make animal drugs and medical devices, that debarment be allowed for misconduct that occurs after a drug is approved and that incentives be devised to encourage FDA to start and complete debarments more quickly and efficiently."

Is Mr. Barton recommending that "crimes" be broadened to include "misconduct?" What does this mean -- and what does "misconduct" include?

Posted by peterpitts at 12:59 PM
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February 08, 2008

ScienceBoarding the FDA

by Peter Pitts

Terrific editorial in the edition Wall Street Journal. And the title says it all, "The Real FDA Scandal."

It puts the FDA Science Board report into the appropriate context -- that despite all of the Congressional bloviating about the FDA "not doing its job," there's plenty of blame to go around -- much of it belonging to those same elected representatives who are the first to throw stones. And you know the proverb.

"Scienceboarding" shouldn't be used to torture the FDA and score political points, rather the Science Board report should be recognized and utilized for what it really is -- a clarion call for appropriate budgeting, smart reform, and strong support for the Critical Path program and the Reagan/Udall Foundation.

Posted by peterpitts at 04:31 PM
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November 30, 2007

Open Source AEs

by Peter Pitts

Mark McClellan (“the hardest working man in American health care") told a gaggle of biotech executives at Lazard Capital Markets' 4th annual health care conference that a new bill passed by Congress will create a vast new database of drug patients by 2012.

McClellan said major health care organizations such as eHealth Initiative, Partners Healthcare and Kaiser Permanente will coordinate with insurers like Wellpoint, Inc.and Unitedhealth Group to gather and collate the data from patients. This initiative is part of the FDA Amendment Act of 2007.

"Most of the evidence on your products will be coming from sources other than you," said McClellan, who sees the information as being more complete and more objective.

If all members of the American health care system can work together and following the same rules (in how they define adverse events and how they use the data) “you've got tens of millions (of people) in the database," said McClellan.

Posted by peterpitts at 10:55 AM
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October 08, 2007

Plan B(TC)

by Peter Pitts

The FDA has announced, via the Federal Register, a November 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist."

The agency wants input on issues such as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.

A BTC category would almost certainly reopen the conversation about the “statin quo.”

In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.

This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.

Posted by peterpitts at 09:24 AM
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September 06, 2007

in PDUFA veritas

by Peter Pitts

Drug Industry Daily

PDUFA Provisions Could Harm FDA and Industry, Expert Say

Some of the provisions in the FDA Revitalization Act, S. 1082 and H.R. 2900, would be ineffective, could cripple the FDA and would put unnecessary burdens on pharmaceutical companies, Center for Medicine in the Public Interest President Peter Pitts said at the Third Annual FDA Regulatory and Compliance Symposium at Harvard University. “Political battles are trumping public health,” he added.

The most important part of the bill is a provision funding the Reagan-Udall Institute and the agency’s Critical Path Initiative, according to Pitts. “This is the single most important advance and change in FDA legislation, possibly ever,” he said. “It really sets the FDA on the path to a 21st century perspective in terms of both protecting the public health and advancing the public health.”

The FDA’s recent label change for Coumadin (warfarin) to add information about genetic tests was “such an important advance,” Pitts said, adding that the agency should continue doing more with the Critical Path Initiative (DID, Aug. 17).

However, Pitts said some provisions in the legislation will be ineffective and could harm the FDA. He criticized a provision that would ban members with more than $50,000 in financial conflicts of interest from voting on advisory committees. The FDA recently issued a draft guidance of a proposed rule that would do the same thing (DID, March 22).

“All this will succeed in doing is allow the agency to recruit the second best and the almost brightest for advisory committees, and that is not acceptable,” Pitts said. He added that $50,000 is an arbitrary limit.

Pitts also criticized the bill’s Risk Evaluation and Mitigation Strategies (REMS) requirements. He noted that early drafts of the bill contained language that would have made it mandatory for each new drug application to contain an REMS. “That’s like saying every new product is equally risky,” Pitts said.

Giving the FDA the authority to require an REMS as part of a new drug application could encourage the agency to call for them more, even when they are unnecessary, he said.

However, the enhanced focus on safety and postmarketing surveillance is the industry’s fault for not living up to its commitments to conduct postmarketing studies, Pitts said. “Now they are reaping what they sowed,” he added. Companies should use the opportunity to conduct postmarketing studies for public health purposes, he said.

Pitts also criticized the provisions in the bill that would add a user fee for a voluntary review of direct-to-consumer advertisements. The FDA’s Division of Drug Marketing, Advertising and Communications has no predictability and will send companies warning letters even if they incorporated all of the agency’s suggestions in their advertisements, according to Pitts. “If the FDA wants to have an impact in quality and safety and appropriateness, they can’t change their minds after the fact, fee or no fee.” — Emily Ethridge

Posted by peterpitts at 10:35 AM
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August 27, 2007

Wuthering Cites

by Peter Pitts

Last Thursday I had the privilege to attend and participate in the third annual FDA Regulatory & Compliance Symposium held at Harvard University. (Or as we Martlets call it, "The McGill University of the South.)

My panel focused on federal preemption and DTC advertising issues. The title of my presentation was "FDA: Advancing the Public Health or Being Led by Political Whims." Needless to say, it was hard to limit my remarks to the requisite 45 minutes.

Two of the other panelists were Alex Sugerman-Brozan (of the Prescription Access Litigation Project) and Lauren Guth Barnes of the law firm Hagens Berman Sobol Shapiro. Perhaps the most polite way to put it is that we didn't agree on most issues.

And that's okay. A feisty, robust -- and respectful debate is always worthwhile. And this panel was certainly all of those things.

Of the many differences, I'm sure you can fill in the blanks vis-à-vis our divergent views on both federal preemption and DTC issues. But what I found most disturbing was that both Alex and Lauren relied, almost exclusively, on partial research data, one-sided anecdotes, and rather selective legal citations.

Their presentations were as one-sided as they were narrow and they lacked any perspective as to the unintended consequences of (what I viewed as) simplistic alternatives. They spoke of solutions driven by adjudication and legislation -- with nary a nod to science.

(Although we did find some common ground on the need for better and more disease awareness advertising and the banishment of reminder ads.)

But (and here's the good news) while their ideas are wrong -- their hearts are in the right place. I really believe that. I hope that, with more conversation (both face-to-face and otherwise) we can all work to help advance the public health through a strong and better funded FDA.

Posted by peterpitts at 08:30 AM
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August 20, 2007

Abigail Force Winds

by Peter Pitts

The recent court decision by the full D.C. Circuit Court of Appeals (reversing an earlier decision by its own three-judge panel) ruled 8-2 against the Abigail Alliance for Better Access to Developmental Drugs' effort to enshrine as a constitutional right a patient's access to unapproved investigational (non-FDA-unapproved) medicines.

Now, before going any further, it's important to point out that there's been a lot of very heated rhetoric on both sides of the issue. And this shouldn't come as a surprise since this is, in the most literal sense, a matter of life and death.

But over-heated rhetoric generally means that each side demonizes the other and neither is listening.

Nobody believes expanded access to drugs under clinical investigation is a bad idea. That's precisely why, when I was at the FDA, we stopped calling such programs "compassionate use." That outdated phrase makes it sound like the FDA and/or any given pharmaceutical company is doing the patient a favor by "being compassionate." Now don't get me wrong, being compassionate is an admirable trait -- but allowing desperately ill patients into clinical trial programs shouldn't be an act of good will, it should be an act of civil society.

But there has to be oversight. There has to be a responsible body that sets rules. Libertarianism, when it comes to pharmaceutical safety, isn't in the best interests of the public health. Does that mean the status quo works? No.

The FDA has proposed changes to address this issue. Do they go far enough? No. Does that mean "expanded access" should morph into "total access" to experimental drugs? No.

In short, there is no black-and-white/right-wrong answer to this question. But that's not what many folks on both sides of the argument are saying.

The FDA needs to reconsider how it can broaden and facilitate expanded access to experimental drugs beyond the current state of affairs (and the state of pending rules). And the Abigail Alliance and their supporters need to keep up the pressure (legal and otherwise) -- but remember they must also work within the system.

Both sides want the same thing -- expedited expanded access programs. But name calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.

Posted by peterpitts at 08:48 AM
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August 06, 2007

Phoning it in

by Peter Pitts

Here's how the Journal of Life Sciences introduces its story on FDA reform:

The FDA needs to rethink the way it communicates in an age of empowered patients.

MUCH HAS CHANGED over the past 25 years, but one of the immutables has been that FDA tries to communicate important health messages without the resources or attitude necessary to do it well on a consistent basis, according to Peter J. Pitts. A big part of the problem is that not only have communications tools changed, but so have people and society. He says the FDA needs to change as well.

Here's the rest of the story:

http://www.tjols.com/commentary/aug1_fda.jsp

And the good news is that Commissioner von Eschenbach believes in strident and robust constituency outreach.

Posted by Peter Pitts on August 2, 2007 9:42 AM | Permalink

Posted by peterpitts at 09:08 AM
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June 19, 2007

No Soap

by Peter Pitts

In the movie “Marathon Man,” Lawrence Olivier’s Mengele-inspired dentist threateningly asks, “Is it safe?” That same question, as Congress debates PDUFA reauthorization and FDA reform, has the real threat of crippling medical progress and the freedom physicians have in deciding which treatments are best for their patients. These are frightening thoughts — and attention must be paid lest we find ourselves, micron-by-micron, abdicating the hope of 21st century medicine to politically expedient measures that serve only to further the political aspirations of sound-bite hungry politicians and the voracious appetites of trial lawyers.

In the Wall Street Journal, Scott Gottlieb addresses the fact that …

“A decade ago, we were mostly focused on uncovering the remote risk that certain drugs could, in rare cases, cause immediate, unexpected and potentially life-threatening problems such as liver damage or disturbed heart rhythms. Surfacing these problems was made easier by the fact that the side effects occurred in close proximity to administration of the medicine, so it could be deduced when the drug was at fault.

Now we're focused on unearthing cases where prolonged use of some drugs may prompt small elevations in the risk of otherwise naturally occurring and even common events, like heart attacks. This was the issue that caused the withdrawal of the painkiller Vioxx and the premature flap around the diabetes drug Avandia.

Our heightened vigilance will surely improve the information people have to make informed choices. But finding and proving these kinds of rare and latent problems will often take many years and entail large and rigorous clinical testing. Even then, deciding if such remote kinds of risk outweigh benefits requires an often subjective calculus that is best left for patients and doctors to decide individually.”

In short, rhetoric and politics, and now actual legislation in the form of REMS, are forcing the FDA ever more towards adopting the Precautionary Principle. That’s the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines.

A little harmless politicking? Hardly. Just ask the people who may soon longer have access to the medicines they need, or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result of the Precautionary Principle is a dearth of new medicines in the pipeline.

Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.

We must not allow safety to be hijacked.

Posted by peterpitts at 09:30 AM
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May 10, 2007

Dogmatic Day Afternoon

by Peter Pitts

Many opinions out there on the FDA Revitalization Act just passed by the Senate.

Here's mine: Don't be dogmatic.

Change is not an all-or-nothing proposition. Small movement in the right direction is the beginning of momentum. (And small victories are better than explosive defeats.)

And remember the words of Plutarch, "Time is the wisest of all counselors."

Posted by peterpitts at 05:27 PM
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March 26, 2007

LA Supplemental

by Peter Pitts

The New York Times editorial page thinks that the FDA should be 100% funded by legislative appropriations. Here we go again.

First, a correction that you will not see in the Gray Lady:

The Times writes that PDUFA fees “help finance the approval process …”

True, but not accurate. PDUFA fees finance the review process. A trivial, rhetorical difference? Certainly not.

So what’s the big deal where the money comes from? Two big reasons:

(1) Reality. Does anybody even remotely familiar with the funding history of the FDA really believe that Congress is going to fund the agency at anywhere near appropriate levels? Indeed, if history is any guide, the reverse would occur.

(2) Alacrity. With PDUFA fees come PDUFA dates. Is our short-term memory so bad that we have already forgotten the shameful days of the “drug-lag?” Yes, folks – it was real.

And to add to their revisionist view of pharmaceutical regulation, the New York Times agrees with many of the agency’s critics that, if only the FDA worked harder, they could replace “conflicted” advisory committee members with ones equally talented and more pure.

Malarkey.

Ladies and Gentlemen – mediocrity is not an option.

When legislators try to rewrite history we suffer the inevitable consequences.

Posted by peterpitts at 08:35 AM
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October 03, 2006

Will Brussels DTC the Light?

by Peter Pitts

According to a recent Populus survey, when asked what reforms would most likely increase their quality of care, people in eight old and new EU member countries responded by a large margin, “giving patients more information about their illness."

And Brussels may indeed be moving in that direction.

Last March in Brussels I appeared on a panel with James Copping, the Principal Administrator for the EU’s Enterprise and Industry Directorate-General, the body drafting the EU’s go-forward recommendations on a how the EU should address what they refer to as ItP or Information-to-Patients.

One interchange between Jim and me that is worth sharing:

COPPING: "We must find new ways to regulate health care information to patients."

PITTS: "Jim, I think a better way to frame the question is to say that you need to find new ways to facilitate health care information to patients.”

COPPING: "Yes, that’s right.”

Well, it seems as though Mr. Copping has done just that.

According to a report in the The Financial Times, draft recommendations prepared for a pharmaceuticals forum, jointly chaired by the European commissioners for enterprise and health, will call for industry participation in partnerships for "information creation and exchange" on diseases for patients and citizens.

They propose a trial scheme to provide "high-quality health-related information" on diabetes, offering data to the non-specialist in all official EU languages, drawing on authorised disease databases, with input from doctors, patient groups and health insurers as well as industry.

The move would mark a significant shift away from the current ban in Europe of US-style "direct to consumer advertising," which forbids drugs companies from any form of direct communication with patients.

With partial exceptions in the UK and Sweden, European legislation prevents drugs companies from even responding to inquiries from patients, let alone advertising their medicines beyond specialist publications for medical professionals. That has created a situation long decried by the industry, by which patients can find all manner of unreliable information on diseases and treatments on the internet, with the pharmaceuticals manufacturers the only groups banned from providing data.

The initiative comes after previous efforts to ease the rules on pharmaceuticals communication were crushed by health insurers and consumer groups wary of industry influence and manipulation.

Good luck Mr. Copping.

Posted by Peter Pitts at 07:58 AM
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September 25, 2006

IOM-anations

by Peter Pitts

I predict the following verbiage from the just released IOM report on FDA reform will NOT appear in any mainstream media reporting:

“Some observers believe that drug withdrawals (which are only one potential indicator of drug safety) represent de facto failures of the drug safety regulatory system, or that newly identified unusual and serious adverse events indicate that someone made a mistake in approving the drug. This is not so.”

Thank you, IOM, for that very honest, bold, timely, and necessary statement. Sorry Senator Grassley. Can we now assign David Graham to the dustbin of history?

The IOM report makes many comments and suggestions. Herewith a few of my own (ps: I have added the appropriate report notation for easy referral):

* Needless to say, the single most important recommendation (and the one that must happen if any of the other ones stand a chance of success) is the very last one — “substantially increased resources in both funds and personnel for the FDA.” (7.1)

* I am glad the that IOM has included in their recommendations my idea of a standing FDA advisory committee on communications. I suggested just such a committee at the November 4, 2005 FDA Part 15 hearing. (6.1)

* A comprehensive review of agency-wide risk communication plans? Absolutely. Lack of centralization has led to overlap, inconsistencies and gaps. Paul Seligman should lead such a program — and immediately. (6.2)

* Similarly, a systematic review of adverse event reporting systems. Yup. When it comes to AERS, we cannot and must not allow miscommunication to lead to health-related unintended consequences. (4.1)

* I certainly agree with the IOM that, when it comes to DTC advertising, the FDA must draw bright lines. But I do not see how a “first five years” moratorium on DTC advertising advances public safety, public health, or public knowledge. Same goes for the black triangle. All that does is triangulate on fear and give trial lawyers a wonderful new weapon in their continued quest for greed. (5.1, 5.3)

* A more timely and comprehensive posting of clinical trials on clinicaltrials.gov? Yes. But as to early stage results — that still needs more debate. (4.11)

* More robust and public discussion of post-market study results. Absolutely. (4.13)

* Adcomm members should be as free of professional conflicts as possible? Duh. But we mustn’t scare away the best and the brightest — as would happen under the proposed Enzi/Kennedy legislation. (4.10)

* Adcomm review of all new NMEs? Shouldn’t that be the decision of the professionals at the FDA? Not all NMEs are alike, so why treat them so? Bad idea. A knee-jerk, Grassley-like suggestion. (4.8)

* Include research capacity in the agency’ s mission statement. This would be a terrific idea if the agency had research capacity — which at present it does not. it should. Fund the Critical Path and then amend the mission statement. (4.7)

* Build a CDER informatics capacity? Totally. (4.6)

* Have the agency work with government partners (such as the VA and DoD), drug companies, public and private insurers, health care provider organizations, and consumer groups to plan, organize and fund confirmatory drug safety and efficacy studies of public health importance. A good idea in theory, but the wording is very vague and could easily lead to a fascist regime of so-called “evidence-based medicine.” Do we really want the editors of Consumers Report telling us which dugs are safe and effective? More debate and clarity needed here. (4.3)

* A 6-year term for the Commissioner of the FDA. Yes. Let the person chosen as Commissioner of the FDA serve as free of the political current as possible. (3.1)

The IOM report has good and bad. But a good next step is to carefully consider them all and expeditiously move forward by taking to heart the words of Goethe that appear on the frontpiece of the report:

“Knowing is not enough; we must apply. Willing is not enough; we must do.”

Posted by Peter Pitts at 09:32 AM
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September 20, 2006

Tshabalala´s remedy: "Garlic, lemon and African potato"

by Michael Martell

Once, an African story-teller told me that real African stories are never written down but are given from generation to generation by oral tradition after sunset sitting around a campfire.

Tshabalala´s remedy story is definitely not a funny tale, it is really a mess. I can understand that scientists, physicians and patients are upset and demonstrate their concerns. But I am at a loss with an answer to the question "How to change her mind and story-telling". Maybe it will help, that journalists have written it down.

Read full article of Financial Times Europe below:

Mbeki's Aids policy 'disastrous'

A group of 81 international scientists working on HIV/Aids have written to Thabo Mbeki, South Africa's president, urging him to end his government's "disastrous, pseudo-scientific policies" on the disease.

In an "Expression of Concern by HIV Scientists", the group also called on Mr Mbeki to sack Manto Tshabalala-Msimang, his health minister, nicknamed "Doctor Beetroot" for her unorthodox views on treating Aids.

The scientists claimed that she had undermined their field by advocating "alternative" remedies to antiretroviral (ARV) drugs, the only medications currently available that alleviate the consequences of HIV infection.
"We are . . . deeply concerned by the proliferation of unproven remedies being marketed in South Africa, some of them with the implicit or even explicit support of the minister of health," said the letter, made public yesterday.

Signatories of the letter included Robert Gallo, credited with co-discovering HIV, and David Baltimore, a winner of the Nobel Peace Prize. The group also endorsed remarks by Mark Wainberg, chairman of the recent international Aids conference in Toronto, describing Mr Mbeki as a "denialist president".

Mr Mbeki has in the past questioned the link between HIV and Aids and the effectiveness of ARVs. Ms Tshabalala-Msimang has angered Aids activists by belittling ARVs and advocating garlic, lemon and the African potato as remedies for patients with suppressed immune systems.

The South African government exhibition at the Toronto conference featured samples of these foods, provoking derision and anger among Aids scientists and activists. "To have as a health minister a person who now has no international respect is an embarrassment to the South African government," the letter said.

South Africa has more than 5m HIV-positive people and one of the world's largest Aids treatment plans. But activists say that fewer than half of the people who need treatment receive it.

No immediate response was available from Mr Mbeki yesterday. He has in the past publicly supported his health minister, whom he reappointed to her post after his re-election to a second term in 2004.

Ms Tshabalala-Msimang is the wife of Mendi Msimang, the treasurer of the ruling African National Congress.

By John Reed in Johannesburg / Published: September 7 2006 / Copyright: The Financial Times Limited 2006

Posted by michael_martell at 12:21 PM
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August 08, 2006

Label Fatigue

by Peter Pitts

The issue of more and ever more black box warnings, beyond any individual therapy or class, is whether the pendulum has swung too far -- and it seems as though that's a real possibility. It's crucial for FDA -- and for those who are irresponsibly calling for "100% safety" -- to realize that pronouncements made in the heat of political debate have serious and deliterious impact on not only the scientific debate, but also on the lives of real people outside the Beltway. Further, as labels become increasingly muddled with more and more warnings, fewer and fewer physicians and patients will pay them any heed. Label fatigue is a real threat to the public health.

Posted by Peter Pitts at 10:55 AM
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