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October 31, 2008
REMS Creep
by Peter Pitts
I recently chaired the "Risk Management and Drug Safety Summit" It was a content-rich experience.
I am still colelcting my notes and my thoughts and will report on what the various speakers (including the FDA's Janet Woodcock, Jane Axelrad) had to say. In the meantime, let me commence this reportage with my own opening remarks:
When I told my wife -- who is not in this line of work -- that I was chairing a conference on REMS, she asked me what I was doing at an event about rapid eye movement.
I can assure you that there will be no REMS sleep allowed during this event.
A common question I get about REMS is – how is it different from what we used to call RiskMAPS? I see two main differences. The first, obviously and importantly, is that REMS has actual legislative language. And that’s an important detail – but it’s one-dimensional.
The second, more important and contentious difference is the environment into which REMS was birthed – an environment in which there is growing realization that the 21st century FDA must add a third leg to its mission of safety and efficacy – and that third leg is safe use. The safe use of drugs. And the formulation, implementation and communication of plans – REMS plans -- that will assist physicians and patients achieve better outcomes through the strategies and tactics devised therein.
According to Dr. Janet Woodcock, “FDA does not control the health care system, so our improving the use of marketed drugs, to a great extent, is going to involve influence rather than control.”
“Influence rather than control” is a savvy and sophisticated concept -- one that many of our elected members of Congress could learn from, and one in which REMS plays an important role.
The FDA’s new "Safe Use" initiative is the patient-facing sibling of the agency’s “Safety First” pharmacovigilance program. But it's more than that -- it's the FDA reasserting ownership of safety from those who would use it only as a mallet of fear. I will not mention names.
That being said, there are those in industry and in the broader healthcare policy arena who look at REMS and don’t see GEMS.
Many have looked at the FDAAA language on REMS and see it as an ill-advised green light for the FDA to inject itself into the practice of medicine.
While I agree that REMS does indeed represent an expansion of the FDA's authority, I do not agree that it is either ill advised or an over-extension of the agency’s purview.
REMS is the responsible extension of the FDA's mission of safety and efficacy into the new realm of safe use. The first real move into this space, if you think about it, was the FDA's change to the warfarin label. Warfarin is complicated to use because the optimal dose varies greatly among patients. With warfarin, if the dose is too strong the risk of serious bleeding increases and if the dose is too weak, the risk of stroke increases.
Via molecular diagnostics specifically called out in the amended FDA label, the health benefits and the resulting savings in health care costs generated by using personalized warfarin dosing decisions are estimated to prevent 85,000 serious bleeding events and 17,000 strokes annually – and that’s just in the
United States. And estimates predict the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually. And that’s the mid-range.
It's important to note that when the FDA announced the warfarin label change the agency (and Larry Lesko in particular) came under attack from critics who asserted that this was the FDA, inappropriately, telling doctors how to practice medicine.
In a recent paper, FDA Deputy Commissioner Randy Lutter said, “The Food and Drug Administration has a key role to play in facilitating the use of genetic information in drug therapies because it approves labels, and labels influence how doctors use drugs.”
It does not take even a small leap of faith to apply the philosophy of REMS to this trend of thought.
The concepts of "safe use" as an integral part of the FDA's 21st century mission and REMS as one of many tactics to achieve better patient care are contentious and crucial. And it is that debate which brings us together today.
Later on this morning we’ll hear from Jane Axelrad, the associate director for policy at CDER. Here’s what Jane had to say recently about REMS, “These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use.”
Whether you say “appropriate” use or “safe” use – the principle is the same – making sure that the risk/benefit analysis of any given therapy is communicated in a lucid and (when required) strident manner.
Sometimes that requires a label change. Sometimes it requires a REMS plan.
But it will always require the active participation and leadership of the FDA in partnership with the pharmaceutical industry, physicians, and yes – even patients. Because no safe use program will succeed without the secret ingredient of patient responsibility.
While some see REMS as mission creep, others see it as the natural and logical extension of FDA responsibility in our new age of more precise diagnostics and personalized medicine.
Posted by peterpitts at 09:35 AM
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October 27, 2008
Who's the new Healthcare IT Girl?
by Peter Pitts
By arguing about the ins and outs of Medicare funding, the presidential candidates are missing a golden opportunity to make the case for the bold health care reforms America desperately needs. Voters should demand that the candidates explain how they would make things like electronic medical records a reality.
The adoption of health information technology will require the knowledge and resources of both the public and private sectors. But health IT will usher in a new era of medicine, improving communication among physicians, helping doctors discover health problems before they grow severe, and allowing medical staff to come up with personalized treatment options.
Posted by peterpitts at 11:47 AM
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October 21, 2008
Digital Expiscatoriation
by Peter Pitts
The always savvy Jim Edwards has a thoughtful and important article in this week’s edition of BrandWeek. Its title, “Why Pharma Fears Social Networking,” says it all.
Almost.
Edwards writes that, “Although a majority of marketers have embraced online social media and user-generated content efforts, one industry is conspicuously not taking advantage of the gold rush: pharmaceuticals.”
His use of the term “gold rush” defines the scope of the article. He’s talking about Pharma and social networking in terms of marketing and sales. Well, it is BrandWeek after all. But there's so much more to Pharma and social networking than just marketing. But I'll get to that in a minute.
Jim continues, “Marketers fear that user-generated content will include complaints about injuries caused by their drugs’ side effects. The law requires these “adverse events” to be reported to the FDA. The FDA’s adverse-event databases are regularly combed by lawyers looking for potential class-action suits. Thus, drug marketers have stuck with a decidedly Web 1.0 model, in which customer interaction is kept to an absolute minimum.”
Indeed. And what a truly 21st century malaise it is – being “decidedly Web 1.0” in a 2.0 world. A digital dilemma if ever there was one -- worse even than restless leg syndrome.
But Edwards believes that, “This head-in-the-sand approach may be about to change. A debate is raging in the drug business as to whether companies should adopt a Web 2.0 strategy. On one side are digital agencies telling companies that online customers generate far fewer adverse event reports than drug companies might expect. On the other side are brand managers, whose every published word must survive a thicket of in-house lawyers, some of whom aren’t Internet savvy. The pressure for drug companies to evolve is growing.”
And I am quoted as follows:
“Drug companies need to begin embracing ways to look for adverse events instead of hoping they don’t stumble across them. I think the attitude of ‘there’s safety in ignorance,’ or active ignorance, is no longer actionable or responsible.”
Looking for the early adaptor? The BrandWeek article calls out Johnson & Johnson for specific kudos.
Edwards writes, “One company is attempting to prove it either way: Johnson & Johnson, which in March acquired Childrenwithdiabetes.com, a community site for parents of kids with diabetes. The site has open bulletin boards and even takes ads from competing companies. Joe Natale, vp-new media, said J&J monitors the site for adverse events and people who give incorrect medical advice, but aside from that anyone can post whatever they want. “The best way to destroy that community would be to in any way hamper or infringe upon the way they create content or share information. If [a company thinks] that every post for every user has to be reviewed and copy-cleared in advance, I will tell you not to waste your time.”
Here is the complete BrandWeek article:
There are legal issues – and they’re important. There are marketing opportunities – and they’re exciting. But what really matters is that social media is a terrific opportunity to help educate the various constituencies of American healthcare about all sorts of important issues. Safety? Sure. But also safe use, compliance/adherence, and a host of others.
If safety is important (and it is very important), then pharmaceutical companies should seek out (rather than side-step) ways to uncover legitimate adverse events. By not engaging in 21st century digital expiscatoriation, industry leaves the FDA with little choice but to pursue its own well meaning (if questionably designed) communications vis-à-vis early safety signals. Silence is leaden. The obvious lines between social media and traditional DTC are obvious and will be used by legislators and pundits intent on hoisting the industry with its own petard. Pharma must lead, follow, or get out of the way. Complaining is not an option.
And neither is avoidance.
Posted by peterpitts at 09:17 AM
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October 16, 2008
FDA Weaves a Web of Safety
by Peter Pitts
A worthwhile effort. Hopefully this will be more than just a "must bookmark" for trial lawyers.
From the FDA website:
FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals
Comsolidates information in once access point
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:
* Drug labeling, including patient labeling, professional labeling, and patient package inserts;
* Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
* A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug's safety, efficacy, or optimal use;
* Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial's purpose, who may participate, locations, and useful phone numbers;
* Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
* Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
* Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
* Regulations and guidance documents;
* Consumer information about using medications safely and disposing of unused medicines;
* Instructions how to report problems to the FDA through its MedWatch program;
* Consumer articles on drug safety; and
* The FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.
"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."
Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.
Posted by peterpitts at 11:14 AM
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October 07, 2008
Pink Ribbon Reality
by Peter Pitts
Will healthcare be discussed during tonight's presidential debate? Smart money says "yes."
So does hopeful money -- since October is Breast Cancer Awareness Month.
That being the case, which candidate deserves to wear the Pink Ribbon?
A few questions to consider before answering:
Which candidate supports a platform that would accelerate the pharmaceutical community and the FDA down the Critical Path?
Which candidate supports a program that believes in getting women with breast cancer the most appropriate care as early in their disease state as possible?
Which candidate supports a program that understands the value of incremental innovation and the "price/value" equation?
Will either candidate speak up for "the four rights" -- the right medicine for the right patient in the right dose at the right time?
Will either candidate wear a pink ribbon tonight?
Will either candidate wear a pink ribbon for reasons other than optics?
Posted by peterpitts at 09:33 AM
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October 06, 2008
Mass Hysteria
by Peter Pitts
Last month two Massachusetts scientists won the Albert Lasker Medical Research Award. Commonly called "America's Nobel Prize," the Lasker Award is the country's most prestigious honor for medical breakthroughs. It was given to BayState biologists for their work on gene expression, the results of which show unprecedented promise in the efforts to combat disease.
The win is a testament to the strength of Massachusetts' medical research community. Yet local legislators have recently instituted a law likely to undermine the inter-industry partnerships essential to just this sort of cutting-edge scientific discovery.
In August, Gov. Deval L. Patrick signed a bill requiring pharmaceutical firms to report to state officials any payments over $50 made to physicians, academic scientists, or other medical professionals. The information - including the names of the people getting paid - will be posted on a public Web site. The bill goes into effect Jan. 1, and provides for fines of up to $5,000 for non-compliance.
This disclosure law is supposed to increase transparency. State officials are understandably worried that money from drug makers could unduly influence research results or physicians' practices. And they want to ensure that patients know if their healthcare provider has a financial incentive to recommend certain treatments.
But publishing this information suggests that there is something wrong with medical professionals working with the pharmaceutical industry. There isn't.
Physicians rely on drug makers for up-to-date information about new treatments. Drug makers in turn rely on doctors for feedback on the real-world clinical effects of their pills - the kind of information that can't be acquired in a laboratory.
The law is also unnecessary. This summer, the drug industry announced strict new limits on sales personnel, banning them from buying lavish meals or giving gifts of any sort during meetings with physicians. Since physicians are often only available for non-patient work during lunchtime, sales reps will only be allowed to pay for the occasional modest meal at a doctor's office, as long as it's "in conjunction with informational presentations."
And under the new guidelines, sales reps are strictly prohibited from passing along information that is anything other than educational.The BayState's disclosure law will stigmatize the doctors it publicizes. Many might leave Massachusetts in favor of a state with a healthier regulatory environment. That would make a bad situation worse: Nearly a quarter of the state's physicians are already considering leaving or are planning to leave because of legal controls on clinical practices, according to a Massachusetts Medical Society report.
The law will also have a dampening effect on academic medical research.
Funds provided by private firms don't compromise lab work they're essential to getting the research off the ground in the first place. Many of Massachusetts' academic medical centers are currently conducting research in partnership with pharmaceutical companies.Scientists are likely to give up on research projects that require corporate sponsorship for fear of jeopardizing their reputations.
Biopharmaceutical companies employ around 55,000 Massachusetts residents, according to the Center for Labor Market Studies at Northeastern University. If researchers start leaving the state to avoid stigmatization, investment dollars and jobs will follow. And that means fewer breakthrough cures from the commonwealth.
Ironically enough, this law's passage comes at a time when state legislators are making a concerted effort elsewhere to bolster the BayState's medical research industry. In June, Gov. Deval L. Patrick approved a 10-year, $1 billion biotechnology initiative, meant to expand investment in state-level research projects.
This new disclosure law hinders those efforts. It will stifle life science innovation, choke off investment dollars into new cures, and destroy medical sector jobs. Patients, physicians, researchers, and average citizens alike should be outraged.
Posted by peterpitts at 12:32 PM
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October 03, 2008
European Commission Calls for More Healthcare Cowbell
by Peter Pitts
Too slowly for some, too swiftly for others, and without any apparent interest by most, the European Commission is moving forwards in its efforts to lubricate the anemic channels through which pharmaceutical companies can communicate with patients (otherwise know as “people”).
According to an article in Europolitics, “The European Commission is standing firm on its objective of authorising pharmaceutical laboratories to communicate directly with patients on the benefits and risks of their prescription products.
The full Europolitics article follows – but here are some tidbits to whet your appetite:
“The idea is also to respond to the expanding use of communication tools - in particular the internet - and patients' growing responsibility for their treatment.”
Wow. Reality. What a concept!
“While the Commission has always denied wanting to authorise advertising for prescription drugs, it was expected to make a clear distinction between non-professional information' and advertising' if the industry is allowed to communicate directly with patients.”
But:
“The EU executive took a step backwards, however, on communication channels: exit radio and TV broadcasting, which "does not protect patients against unsolicited information".
However:
“… the Commission intends to maintain the print media in its proposal. It nevertheless puts emphasis on the internet, saying it offers "almost unlimited access to information without taking account of national borders."
So, there can be advertising , but not advertising.
And for all you DDMAC fans out there:
“The European Agency for the Evaluation of Medicinal Products (EMEA), based in London, would also play a role: laboratories would have to notify their information prior to publication and the EMEA would have 60 days to express any compliance objections, after which the information would be published.”
And to make things even more confusing:
“For the monitoring of information, the Commission is expected to propose an ex-post mechanism (after dissemination of information to patients). The member states will define the rules. They could nevertheless set up prior monitoring - and clearance by the competent authorities - for information for which it is hard to make a distinction between non-promotional information' and advertising'.”
Note: This is the difference between federation and confederation. It is also a lesson in why concepts like … preemption ... are so important. But I digress.
Here is the compete article from Europolitics:
Prescription Drugs: Pharmaceutical Firms Authorised to Inform Patients
The European Commission is standing firm on its objective of authorising pharmaceutical laboratories to communicate directly with patients on the benefits and risks of their prescription products. In a draft directive due out in late October(1), the EU executive is expected to stand up to the criticisms of health care professionals, sickness insurance bodies and several patient and consumer organisations, which accuse it of trying to do away with the European ban on advertising for prescription drugs.
With this proposal (subject to co-decision), of which Europolitics obtained a copy, the Commission intends to iron out the differences between national laws, which range from allowing information that is strictly supervised by drug regulatory authorities, to public private partnerships between health care professionals, patient associations and industry.
QUALITY CRITERIA
While the Commission has always denied wanting to authorise advertising for prescription drugs, it was expected to make a clear distinction between non-professional information' and advertising' if the industry is allowed to communicate directly with patients. Its answer is that "the content of authorised information must be defined". According to the proposal, industry would be authorised to communicate on the instructions for drug use, prices, changes in packaging, warnings on side effects, the absence of scientific studies and prevention and treatment support measures. Information on human health and illnesses as such is not concerned.
Quality criteria are established: the information must be objective and non-biased, take patients' needs and expectations into account, be based on factual and verifiable data (declaration on the extent of evidence), up-to-date, reliable, factually accurate and not misleading, comprehensible to patients and the general public, stem from a clearly identifiable source and compatible with the summary of product characteristics and patient information brochures as approved by the competent authorities. Comparisons between drugs are prohibited.
INTERNET AND PRINT MEDIA
The EU executive took a step backwards, however, on communication channels: exit radio and TV broadcasting, which "does not protect patients against unsolicited information". This eventuality, discussed by the Commission in its public consultation documents, was rejected by the member states, even the most liberal stakes like the
UK, but also by laboratories. The European Federation of Pharmaceutical Industries and Associations (EFPIA), for example, had informed the Commission that its members did not wish to engage in direct advertising as in the United States and that reflection on passive information via TV, radio and the print media tied into that. However, the Commission intends to maintain the print media in its proposal. It nevertheless puts emphasis on the internet, saying it offers "almost unlimited access to information without taking account of national borders". And it adds that "specific rules on site surveillance should be put in place to take account of the cross-border nature of the information provided on internet and to allow cooperation between member states". Patients could, for example, write to industry in any of the EU's 23 official languages to request information in that language.
EX-POST MONITORING
For the monitoring of information, the Commission is expected to propose an ex-post mechanism (after dissemination of information to patients). The member states will define the rules. They could nevertheless set up prior monitoring - and clearance by the competent authorities - for information for which it is hard to make a distinction between non-promotional information' and advertising'. The national authorities will have to ensure that information is accessible to people with disabilities, unless this requires too much paperwork in laboratories. Such a regulated mechanism nevertheless does not rule out voluntary regulation by industry or co-regulation by industry and the public authorities. At a debate in the Health Council, on 10 June in
Luxembourg, most of the member states expressed a preference for prior monitoring of information. Sweden noted, however, that possibilities for ex-post monitoring could lower the administrative costs involved (see Europolitics 3548).
It will also be for the member states to ensure that companies are fined or taken to court for "repeated and serious cases of non-compliance" with the new rules. The name of the company would be made public. The European Agency for the Evaluation of Medicinal Products (EMEA), based in
London, would also play a role: laboratories would have to notify their information prior to publication and the EMEA would have 60 days to express any compliance objections, after which the information would be published.
The Commission also gives itself the possibility to revise the directive five years after its entry into force. The proposal concerns only prescription drugs, since existing EU rules authorise advertising by laboratories for over-the-counter drugs, under certain conditions.
Posted by peterpitts at 02:20 PM
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