Latest Drugwonks' Blog
First weigh the considerations, then take the risks.
-- Helmuth von Moltke
For you PDUFA junkies, some important reading prior to the upcoming E&C and HELP hearings.
Some snippets from a pre-publication copy …
A Risk-Characterization Framework for Decision-Making at the Food and Drug AdministrationCommittee on Ranking FDA Product Categories Based on Health Consequences, Phase II, Board on Environmental Studies and Toxicology Division on Earth and Life Studies, National Research Council, Institute of Medicine
FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. As a result of that request, NRC formed the Committee on Ranking FDA Product Categories Based on Health Consequences.
Difficult decisions are common for the Food and Drug Administration (FDA). Whether it is allocating scarce resources, deciding how to mitigate newly found risks, or deciding what investments in human capital, facilities, data, or analytic methods would be most useful, decision-makers in the FDA often need to integrate data of varied quality, recognize uncertainties, and make trade-offs to arrive at a decision. Public-health and public-safety concerns must be balanced with the economic realities of budgets and the political constraints of imposing new regulations.How a program is presented by the media and understood by the public is an important determinant of the acceptance and success of the program. Science and public preferences and perceptions must be considered if one is to understand the potential outcomes of different decision options. To inform the decision-making process, data of differing degrees of quality and robustness must be used and sometimes fed through an array of models of varied sophistication. Expert opinion must be used to interpret the relevance of available data and to solve problems on which available data are weak or nonexistent. Immovable deadlines can thwart uncompromising reliance on the most thorough analysis based on detailed quantitative data for a given decision.
To succeed in such an environment, FDA needs a framework within which alternatives can be defined and evaluated systematically. Although it is beyond the scope of the present study to provide a comprehensive decision-making procedure for FDA, the committee proposes a general framework for thinking about and characterizing the human-health dimensions of FDA decisions. Health consequences are only a subset of the large array of factors that must be considered for any given problem. However, they constitute a reasonable place to start the process of developing a decision framework inasmuch as such factors loom large in most FDA decisions and substantial work has already been done on methods for estimating the human-health consequences associated with various risks, hazards, and decisions.
The framework offered here provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for FDA decision-making.
This chapter first provides a brief description of the proposed framework and the risk and decision contexts that influenced the committee’s approach. Next, the basis and definition of the risk attributes that characterize the framework are provided, and then some approaches for estimating the outcomes of decisions using the risk attributes are described. The chapter concludes with a discussion of how the output of the framework can be used to support decision-making.
THE FRAMEWORK
The risk-characterization framework is designed to be as general as possible while providing consistent risk information in a way that can be used to support the wide variety of decisions that FDA faces. It is intended to supplement and augment other risk-based and risk-informed approaches that are in use and under development by FDA, not to be a replacement or a one-size-fits-all prescription for conducting all risk-informed decision-making.Indeed, the committee recognizes that the public-health consequence factors highlighted in this framework will seldom be the only important considerations in the decision-making process, but they are almost always some of the key considerations. The U.S. Nuclear Regulatory Commission has also recognized that risks are not the only factors that must be taken into account in regulatory decision-making. It recently embraced the concept of risk-informed decision-making, which it defines as “the use of risk insights, along with other important information, to help in making decisions” (USNRC 2008, page 1-1). The committee’s framework focuses on risk information but also recognizes that other information will be relevant for most FDA decisions.
The process is straightforward and involves three steps:Step 1. Identify and define the decision context: What decision options are being considered? What are the appropriate end points to evaluate and compare?
Step 2. Estimate or characterize the public-health consequences of each option by using the risk attributes that are described below. The values of the risk attributes should be summarized in a table to facilitate comparison of the options.
Step 3. Use the completed characterization as a way to compare decision options and to communicate their public-health consequences within the agency, to decision-makers, and to the public; use the comparison with other decision-relevant information to make informed decisions. Although the steps can be easily articulated, they involve thought and effort to complete.
The framework is not a cookbook and will require FDA to exercise judgment in how it is used.
The full report can be found here.
The policy of being too cautious is the greatest risk of all.
Jawaharlal Nehru
The American Spectator
Center of Attention
FIRM STAND
Re: Robert Goldberg's Smearing Mitch:
The Center for Public Integrity firmly stands behind its May 9 story on Gov. Mitch Daniels and his prior employment with Eli Lilly. The recent letter [sic] from Robert Goldberg appears to be little more than an apology for the illegal behavior of the pharmaceutical giant during Daniels' tenure and an ad hominem attack on the Center.
The facts are irrefutable: During Daniels' time there, Lilly pleaded guilty to two criminal misdemeanors, paid more than $2.7 billion in fines and damages, settled more than 32,000 personal injury claims -- and agreed to settle one of the largest state consumer protection cases involving a drug company in U.S. history.
Mr. Daniels was a senior executive with the company during this dark period, and as he weighs a presidential bid, it is the responsibility and duty of the media to investigate his work history and professional associations. Starting in 1990, Daniels served as vice president of corporate affairs, then as president of Lilly's North American pharmaceutical operations, and finally in 1997, as senior vice president of corporate strategy and policy. He cannot claim to be "out of the loop."
Lastly, Mr. Goldberg's insinuation that the Center was somehow used by our esteemed board member Arianna Huffington or a mental health activist to attack Eli Lilly and Mitch Daniels is simultaneously insulting and absurd. The Center is not -- and never has been -- a pen for hire. We are nonpartisan investigative news organization and we follow the facts wherever they lead.
-- William E. Buzenberg
Executive Director, Center for Public Integrity
Robert Goldberg replies:
Mr. Buzenberg's letter confirms the point of my article. The Center for Public Integrity claims that "by providing thorough, thoughtful, and objective analyses, the Center serves as a provider of factual information."
Mr. Buzenberg's response possesses none of those qualities.
Characterizing Governor Daniels' tenure as "this dark period" is all we need to know about how objective Buzenberg and CPI really are. I do not apologize for Lilly's illegal behavior. Rather, I provide the background about the use of the False Claims Act as a platform for government and third party plaintiff lawsuits against pharmaceutical firms. As I noted in my article: "Eli Lilly engaged in illegal activity. But here's the gist of its unlawful actions: Eli Lilly was accused of providing doctors with medical information that Zyprexa could be used to treat agitation in people diagnosed with dementia and sleep disorders in people with schizophrenia." I also noted that Medicaid programs reimbursed the off-label promotion of Zyprexa and Evista.
I did not note -- because of space considerations -- what CPI knows and did not report about the 32,000 claims: These were not 32,000 individuals all suing Lilly individually. These were, as James Beck has written about such cases, "thousands, of plaintiffs -- and no information about any of them. It amounts to an instant mass tort. Often it's worse, in that otherwise diverse plaintiffs are fraudulently misjoined with non-diverse plaintiffs (or non-diverse defendants against which only very few plaintiffs have a claim)." In other words, most of the claims were either bogus, or filed by people who did not even take Zyprexa or benefitted from the drug.
Lilly settled these 32,000 claims only because it costs over $30,000 to review and validate each one. The fact that Lilly settled for $500 million (compared to the total cost of $960 million of reviewing each one) suggests that most claims were flimsy or false. Kenen and Sharpe, the CPI report's authors, ignore these details as well as the fact that 90 percent of the claims Lilly did challenge were dismissed. So much for Lilly's "dark period."
Further, Kenen and Sharpe omit important facts surrounding the Second Circuit Court's reversal of a lower court decision that Lilly's off-label activity caused third party payers to cough up more for Zyprexa than they otherwise would have. The reporters say the 2nd Circuit merely ruled that the third parties could not sue as a class. In fact, as described by litigation attorneys John P. Stigi III and Eric S. O'Connor, "At the core of this decision is the Second Circuit's rejection of the use of 'aggregate proof' of causation in the consumer class certification process." There was no individualized proof rather than generalized proof of causation (i.e. the assertion that Lilly's marketing of Zyprexa caused the plaintiffs to pay a higher price for the drug than they otherwise would have).
In Buzenberg's mind, if Kenen and Sharpe had included such information it would been like apologizing for illegal activity.
Finally, there is the claim that I am "insinuating that the Center was somehow used by our esteemed board member Arianna Huffington or a mental health activist to attack Eli Lilly and Mitch Daniels." Buzenberg goes on to assert: "The Center is not -- and never has been -- a pen for hire. We are nonpartisan investigative news organization and we follow the facts wherever they lead."
First, I was not insinuating but asking a question: How did the reporters get to Ellen Liversidge, a "mental health activist" with ties to Scientology-based groups and Peter Breggin. I speculate, given Huffington's long and persistent attention to Eli Lilly, her crusade against psychiatric medications, and the fact that the Huffington Post was a platform for people that shared her views, that perhaps Huffington or Breggin suggested Liversidge to Kenen and Sharpe. Indeed, the reporters do not mention Liversidge's groups, an odd omission since telling her story is at the core of her "activism." As for CPI's "esteemed" board member, her role in undermining confidence in vaccines and prescription drugs is worth a full article and then some.
I don't believe the Center is a pen for hire. I do believe it has an ideological agenda and a sense of righteous entitlement that colors its reporting.
Insurers begin to adapt to health reform law
By Jennifer Collins Marketplace Morning Report, Friday, May 20, 2011In order to pay for the coverage they'll have to provide for those with preexisting conditions, health insurance companies have been trying to raise premiums by double-digits. Come fall, they won't be able to without approval.
Jeremy Hobson: The federal government has announced new rules for health insurance companies as part of the Obama health care law. Starting September 1 companies will have to get approval if they want to raise premiums by more than 10 percent.
The insurers say that'll lead them to drop coverage in some areas, as Marketplace's Jennifer Collins reports.
Jennifer Collins: One of the big promises of health care reform is that everyone in the U.S. can get coverage, regardless of preexisting conditions.
Ethan Rome is with Health Care for America NOW! He says insurers anticipate paying for all those preexisting conditions.
Ethan Rome: And they've been jacking up rates at double-digit levels.
Starting this fall, if insurance companies want double-digit increases, they'll need permission to do it on individual or small group plans. Peter Pitts is with the Center for Medicine in the Public Interest.
Peter Pitts: Certain insurance companies will just decide not to do business in certain states and areas where they simply can't get the rates they need to stay in business.
Christopher Bowe is a health care analyst with Informa.
Bowe: My guess is they'll be flexible and look for ways to change their business model to stay profitable and become more efficient.
He says insurers have shown flexibility. The health insurance industry is on its way to a third year of record profits.
I'm Jennifer Collins for Marketplace.
Political Hay
Smearing Mitch
The Center for Public Integrity (CPI) recently issued a report accusing Governor Mitch Daniels, who once was President of North American operations for Eli Lilly, of illegally marketing medicines that caused thousands of people to get sick and die.
It's a riveting story but it's not true. Instead, the report, written by Joanne Kenen and Rochelle Sharpe, is full of misstatements, inaccuracies, and outright falsehoods. If the Center for Public Integrity had any integrity it would yank the piece, apologize to Governor Daniels, and start asking who pushed to release such a sleazy ad hominem assault.
Here's the gist of the allegations:
In the decade that Daniels climbed the corporate ladder at Eli Lilly, the company was illegally marketing its leading osteoporosis drug, Evista, as well as its blockbuster antipsychotic, Zyprexa, putting tens of thousands of patients in harm's way. Lilly pleaded guilty to two criminal misdemeanors, paid more than $2.7 billion in fines and damages, settled more than 32,000 personal injury claims -- and copped to one of the largest state consumer protection cases involving a drug company in U.S. history, a review by iWatch News shows.
Eli Lilly engaged in illegal activity. But here's the gist of its unlawful actions: Eli Lilly was accused of providing doctors with medical information that Zyprexa could be used to treat agitation in people diagnosed with dementia and sleep disorders in people with schizophrenia. The government calls the distribution of such material without FDA approval a "false claim." A "false claim" is not a false statement. Rather, it's clinical data or published studies that confirm the effectiveness of new uses for existing medicines.
In other words, if Eli Lilly shared medical studies demonstrating that using a drug prevents cancer, it would be breaking the law.
In fact, that's what Lilly was fined $36 million for in 2005. The government had gone after it for telling doctors that Evista -- originally approved to reduce bone loss -- was also effective in preventing cancer in postmenopausal women. In 2007 the FDA approved Evista as a cancer preventive. During this time Medicare and Medicaid were paying for the off-label use of both Zyprexa and Evista.
Kenen and Sharpe also allege that under Daniels Lilly downplayed Zyprexa's side effects of significant weight gain and increases in blood sugar that could cause diabetes. In fact, the federal judge presiding over Zyprexa litigation noted "the original 1996 Zyprexa label listed the relevant adverse events; in 2003 the FDA… required a hyperglycemia and diabetes warning; the American Diabetes Association and other groups in 2003… issued a consensus statement on antipsychotic and weight gain and diabetes… a Dear Doctor Letter went out in March 2004. "
Further, since 1999 the company has published hundreds of articles examining the association between Zyprexa, glucose levels, and obesity and including research intended to help predict weight gain. That's in addition to scores of other papers written by others.
Still Kenen and Sharpe want to link Daniels to thousands of Zyprexa-caused injuries and deaths. To dramatize their case, the authors introduce us to Ellen Liversidge, who states: "Eli Lilly killed my only son." Her son Rob, 39, died in 2002 after taking Zyprexa. "I think they are terrible. They hid the side effects of so many drugs."
In fact, as Liversidge notes in another interview, her son died because "the intensive care unit team did not have his blood-sugar level checked for signs of hyperglycemia."
Liversidge is a member and founder of two organizations with ties to Ann Blake Tracy, an advisor to the Scientology-backed Citizens Commission on Human Rights, and Dr. Peter Breggin, who over the years has claimed that treating mental illness with medicine is a form of abuse.
Breggin has been an "expert witness" in many of the lawsuits against Zyprexa.
And Breggin is also a featured blogger on the Huffington Post, whose founder, Arianna Huffington, is a CPI board member.
Huffington and Breggin share a particular animus against Eli Lilly and Daniels in particular.
Since 1998, Huffington has waged a war of words against Eli Lilly for promoting Prozac and Zyprexa. She alleged in 2002 that Daniels was behind an effort to protect vaccine makers from lawsuits from parents who claimed shots made by Lilly and others caused their children's autism because they contained thimerosal. In 2005 she launched the Huffington Post and featured several anti-vaccine and pseudoscience fearmongers as bloggers, including Andrew Wakefield, Jenny McCarthy, and of course, Peter Breggin.
Did either Breggin or Huffington suggest or contribute to CPI's report? The link between CPI and Huffington's campaign against Mitch Daniels bears more scrutiny than the baseless claims that the Indiana governor presided over an orgy of criminal behavior.
CDER no evil?
Via BioCentury ...
CDER seeks to limit scope of Avastin hearing
FDA's Center for Drug Evaluation and Research said it does not believe future studies of Avastin bevacizumab are within the scope of a hearing on FDA's proposed withdrawal of metastatic breast cancer from Avastin's label. In a letter from CDER to CBER Director Karen Midthun, who is presiding officer for the June 28-29 hearing, CDER said future studies are not relevant to the center's conclusion that currently available data have failed to confirm the safety and efficacy of Avastin for the indication. CDER argues in the letter that the topic of withdrawal should be considered separately from the topic of future clinical trials. Genentech Inc. said it is submitting a response to CDER's letter.
However, Midthun has already indicated that future trials are a topic for discussion at the hearing. If the FDA commissioner agrees data provide grounds for withdrawal, the hearing will consider whether Avastin's accelerated approval should be maintained while Genentech conducts a confirmatory trial, according to the hearing's Federal Register notice posted last week. On Monday, the Roche (SIX:ROG; OTCQX:RHHBY) unit indicated it would focus its argument on that question.
Lead, follow ... or get out of the way.
From the pages of Health Policy News:
FDA Weighs Role of Social Media In Agency Communications
FDA is seeking social media advice for its own communications practices as it crafts a much-anticipated guidance to govern the drug industry's utilization of Web 2.0 tools, with the agency struggling with how much its outreach efforts should include new Internet-based applications. The agency is mulling whether to take a more active role in social media outlets to interact with the public on issues like recalls and enforcement actions, but a former FDA communications official said the agency needs to embrace new media now to fulfill its public health mandate and to set an example for the industries it regulates.
As more doctors turn to social media to communicate with patients and because it has proven to be a vital tool in drug crises, FDA is evaluating how much it should participate in this evolving platform, indicating that it is a "gray area" for the agency to have staff actively participating in tools like Facebook and Twitter, agency officials said May 6 during a Risk Communication Advisory Committee meeting.
Advisory committee members and FDA officials indicated that by, for example, following people on Twitter, the government would have more interaction with the public. Greg Busse of the drug center's safety and risk communications team, said the psychological power of such an action would allow the government to engage in dialogue with with public.
"Whether or not it will ever come to light, whether it will work that way, I'm not sure," he said.
FDA has several Twitter feeds based on different topic areas, but each feed only follows a handful of government agencies and health organizations. The agency does not retweet information from other users. While following indicates whose information FDA is monitoring, retweeting, or sharing other users' ideas, indicates interaction with others on the media platform.
FDA has also researched the diffusion of and feedback from its message on various topics, including the peanut butter and egg recalls, action taken against Four Loko caffeinated alcoholic beverages and issues surrounding genetically engineered salmon.
Peter Pitts, president of the Center for Medicine in the Public Interest, told FDA Week that FDA needs to take action in the social media realm because it is where people are now getting their information and it advances the agency's public health mission. Further, he said the agency has already collected enough information through public meetings and studies to advance its use.
"Social media isn't an option," said Pitts, a former associate commissioner for external relations at FDA. "Social media is for many Americans their exclusive pathway for health information."
While all channels of social media should be embraced by the agency, he said video should be prioritized. The way the agency handles these platforms could direct industry, he said. "The FDA could do wonders by leading by example," said Pitts, who is also a consultant to the advisory committee.
Committee members said the agency could build trust and reinforce its message through the social media tools. "I think part of the challenge is sort of being authoritative and also accessible and responsive," one committee member said. Committee members also noted the repetition that comes from social media has positives and negatives as the agency's message could be manipulated and quickly disseminated.
The limited available space to convey risk-benefit information and viral nature of a social media message has also caused concern among industry, which has been pushing for guidance for how it can use these new tools without running afoul to marketing regulations. In recent weeks, FDA announced a series of studies on the Internet intended to inform the guidance, which in turn is likely to delay the document that has missed two goals for issuance.
During the meeting, Elisabeth George, a vice president with Philips Healthcare, questioned the committee on industry's responsibilities. As directed by the agency, "if there is any off-label use that is being done with our products or if there is any misinformation with respect to safety and efficacy, we need to take action ," she said. But it is unclear how far regulators expect industry to go in policing the information, she said.
To paraphrase Douglas MacArthur, “The patient, and the patient, and the patient.”
That’s my optimistic take-away from yesterday’s Patient-Centered Outcomes Research Institute (PCORI) Board of Governors meeting.
But, you know what they say about best intentions.
The session began on a less than auspicious note with a PowerPoint presentation from the PCORI-retained public relations firm on how to best develop the institute’s “brand.” Suffice it to say there was a lot of multitasking going on. What’s next on this particular agenda? A PCORI theme song?
Then it was time to get down to serious business. And the first was the announcement of Joe Selby as PCORI’s first executive director. (He is a member of the Institute of Medicine, where he has studied quality and effectiveness issues. Selby joins Team PCORI from Kaiser Permanente in Northern California where he was director of the research division and oversaw a team of over 50 investigators and 500 research staff working on more than 250 ongoing studies.)
After PCORI Chairman Eugene Washington made the announcement, Selby commented, “For those of you participating in this meeting via webcast, I’m the one who looks like a deer in the headlights.”
Good luck Joe. You’ll need it.
Various discussion items followed. Of particular interest was that of PCORI undertaking (led by the Program Development Committee) of a Landscape Review of comparative effectiveness research (CER) – and this generated much debate. Most important (and bear with me for a minute on this) was whether or not, once completed, this mega lit search should be posted on the PCORI web site. It was astutely pointed out that this should not be the case – as it would give a sort of implied official imprimatur to the listed studies. Surprisingly and positively there was general agreement that this survey should not appear online.
There was then a general discussion on what the “legacy” of PCORI would be. And while that might sound a little grandiose and, well, premature – it did focus the board on what unique research role the institute can play in advancing the public health from a patient-centric perspective.
No real answer. But a good question and the best comment came from NIH Director Francis Collins who said that if PCORI was looking for a unique and non-duplicative research agenda, it would be “a null set.”
Public comment followed. Mine consisted of the following points:
PCORI should not forget about outcomes data. Perhaps the institute should lead the way in coordinating the many large data sets of outcomes data held by both Uncle Sam and private payers. The use of outcomes data needs to go beyond (well beyond) well-intentioned (but relatively small) CMS pilot projects. The United Kingdom has such a nationwide system – but hasn’t been particularly creative or aggressive in using it. PCORI should take the lead. After all, what’s more patient-centered than real world outcomes data?
PCORI should create a program on educating patients, physicians and payers on the use and importance of molecular diagnostics. After all, what’s more patient-centric than early diagnosis and advancing the “four rights” of the right medicine in the right dose to the right patient at the right time?
PCORI should help to advance the nascent science of adaptive clinical trials by creating and creating a home for www.adaptiveclinicaltrials.gov. After all, what’s more patient-centric than adaptive clinical trial information?
PCORI should stay as far away as possible from discussions of CER as a method for cost controls – as this is a slippery slope to price controls. And price controls equal choice controls. Moreover, PCORI is officially tasked not to pursue comparative effectiveness but comparative clinical effectiveness. Comparative means which treatment (or healthcare technology if you prefer) is “better” (subjective) versus data on real world clinical outcomes. To put it bluntly, “comparative” is subjective. “Clinical” is outcomes-driven. It’s important to remember both the letter and the spirit of the stature.
(In fact, Francis Collins warned the board to “beware of the tension between CER and personalized medicine.)
PCORI should be careful in creating a databank of CER studies because (and particularly when you consider programs such as CATIE and ALLHAT) garbage in, garbage out.
PCORI should beware of information sharing via academic detailing. (Note: 20% of the PCORI budget is ear-marked to AHRQ for “information dissemination.) ‘Nuff said.
PCORI should (indeed must!) define “patient-centered” as care first and cost second – otherwise the “PC” in its acronym will only mean “politically correct.”
Next up was the report of the Methodology Committee and the centerpiece of this portion of the program was a working definition of “patient-centered outcomes research” (PCOR). (Note: the word of the day was “iterative.") Here is the committee’s first draft effort
“Patient-Centered Outcomes Research helps people make informed decisions and allows their voice to be heard in assessing the value of healthcare options. Given my personal characteristics, condition and preferences, what should I expect will happen to me? What are my options and what are the benefits and harms of those options? And what can I do to improve the outcomes that are most important to me?
Nice. These “four questions of PCOR” should be widely shared and discussed. If PCORI is looking ahead towards its “legacy,” this is a good place to start.
At the end of the meeting, one of the board members came up to me and said, “I don’t think you understand what PCORI is about.” She was confused that I had brought up the issue of cost controls in my remarks. “Don’t you know what we are, by statute, not allowed to take costs into consideration in our work?”
I told her that I understood very well – but that, well, you know what they say about good intentions.
Maybe they should call him Tom “Godot” Abrams.
Maybe not. DDMAC continues to get slammed for not issuing the social media guidance it most recently promised to “try” to get out by the end of first quarter 2011. While, on the one hand, one shouldn’t raise expectations (even by “trying”), DDMAC guidances (be they draft or otherwise) are a Trojan Horse.
The Bauhaus Boys said it best. “Less is More,” opined the great Walter Gropius. “But” amended Mies van der Rohe, “More tastes better.”
Both are relevant to the issue of DDMAC and social media. On the one hand, less (at least in theory) allows regulated industry to make its own rules, to find its own way. More, on the other hand, is what pharma seems to want. And, to be fair, predictability is always better than ambiguity when it comes to FDA regulations. Alas, that is not always possible – and expecting it (like Waiting for Godot) makes for absurdist theatre.
Here’s an article from the current edition of Ad Age that can be pretty well summed up in this quote from Samuel Beckett:
What do I know of man's destiny? I could tell you more about radishes.
FDA Guidelines Set for '10 Still Nowhere to Be SeenPharma Companies Still Waiting for Social-Media Guidance, but a New 60-Day Public-Comment Period Was Just Opened
Still waiting on those Food and Drug Administration pharmaceutical guidelines for social media and online advertising? Don't hold your breath.The FDA has opened a 60-day public-comment period to study the impact of online consumer advertising for prescription drugs, further delaying the implementation of new rules for internet and social-media marketing -- rules that had been expected for months now.
The continuing delay is bad news for the industry, which is beset by stagnant new product pipelines and the patent expiration in the next 18 months of several blockbusters that account for more than $51 billion in annual sales, including Pfizer's Lipitor, the world's best-selling prescription medication. Big Pharma has looked to goose profits in several ways, including lowering ad spending with cheaper marketing platforms such as branded websites and social media.
Digital spending is on the rise -- eMarketer estimated that health-care and pharma companies spent $1.03 billion on internet ads last year, up 13.9% from 2009 -- but drug makers are inhibited from doing more by a lack of guidance for social media.
In a notice in the Federal Register, the FDA said it would conduct three concurrent studies in order to assess how current advertising rules governing print, radio and TV ads will apply to social media. Specifically, how do drug companies portray accurate and complete "fair balance" -- the risk and benefit information -- in a Facebook post or a 140-character tweet?
Though these studies and this new comment period that ends June 27 are separate from the agency's November 2009 hearing and public comment period on social media, the FDA said in its notice that the new study "will complement qualitative research we plan to conduct on issues surrounding social media."
Translation? Those social-media guidelines the FDA said it would deliver in 2010, and then put off until the first quarter of 2011, and are still nowhere to be seen six weeks into the second quarter. And they are still a long way off.
"This [new study] is completely different and it's completely irrelevant. This is just the FDA continuing to try to solicit input on what elements of advertising influence people in different ways," said Peter Pitts, former FDA associate commissioner and now the president of the Center for Medicine in the Public Interest. "What it's showing is just how behind the curve the agency really is."
The FDA admits the problem, saying in its notice in the Federal Register that, "The original regulations that presently determine FDA's position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development."
There is, by and large, almost complete agreement in that assessment from all parties concerned. Now comes the waiting.
"To be candid, if you look at FDA historically, this is typical for them. FDA is loath to move quickly unless it involves product liability, like if someone is about to be poisoned by bad food," said longtime health-care agency executive Mike Guarini, the president of Connecticut-based Ryan TrueHealth. "Putting in social-media guidelines has become a joke. They don't know when they're going to do it, and neither does anybody else."
Asked if the delay is hurting business, Mr. Guarini said "Absolutely. No question about it. What I hear from clients and prospective clients is 'I want to do more in social media, but I don't know if it's good, bad or even legal.' The industry would just like some guidelines."
When that will be, however, remains to be seen. The FDA offered no timetable, saying only in its notice that "The series of studies described in this notice will provide data that, along with other input and considerations, will inform the development of future guidance."
In December 1, 2003, the Washington Post ran this story on the front page:
Google to drop rogue-pharmacy ads: Move is part of government effort vs. illegal drugs
Google, the popular search engine, will stop accepting advertising from unlicensed pharmacies that have used the Internet to sell millions of doses of narcotics and prescription drugs without medical supervision, company officials said.
The decision by Google Inc., based in Mountain View, Calif., comes as regulators and members of Congress shift their focus from the illicit pharmacies to the legitimate Web portals, credit card companies, shippers, and banks that facilitate the sales. Three congressional committees are looking into the issue.
Federal regulators, who have limited authority over online advertising, are examining how they can prod the search engines and other businesses to deal only with legitimate pharmacies.
"We're literally placing calls to the search engines trying to get a meeting going," said Peter Pitts, the FDA's associate commissioner for external affairs. "You can't blame them for accepting commerce. But they really haven't understood the consequences."
Nearly eight years later, it seems those consequences are somewhat better understood. Today this story hit the pages of the New York Times:
U.S. Inquiry of Google on Drug Ads
Federal regulators are investigating Google on suspicion of illegally displaying ads for online pharmacies that are operating outside the law, government officials said Thursday.
Google has set aside $500 million to pay for a potential settlement, according to a Securities and Exchange Commission filing the company made on Tuesday. It said the money was for the “potential resolution of an investigation by the United States Department of Justice into the use of Google advertising by certain advertisers,” but gave no details.
In the last year, Google has made significant changes to its policies for accepting pharmaceutical ads, most recently in January. But Michael Zwibelman, litigation counsel for Google, has described it as “an ongoing, escalating cat-and-mouse game.”
In February 2010, Google changed its AdWords policy to accept ads only from pharmacies certified by the National Association Boards of Pharmacy in the United States or the Canadian International Pharmacy Association.
Better late than never.
On and off the battlefield, uncontrolled bleeding and inflammation from traumatic brain injuries (TBI) is the leading cause of death among our soldiers as well as young adults. Over the past decade, a drug to control hemophilia has be used to stop brain bleeding faster TBI caused bleeds more quickly had helped reduce death and post TBI disabilities. And recently scientists began work on a simple blood test for diagnosing head trauma as well as a new drug that shuts down inflammation itself.
Current treatments might not have been available if something called comparative-effectiveness research (CER) was in place ten year ago. CER compares the cost and effectiveness of old technologies in treating a disease to medical innovations. Under Obamacare, CER is being used in determining whether new technologies can be covered by health plans, Medicare and the Veteran’s Administration. A recent CER study stated that there was no evidence that a clotting drug used to save the lives of soldiers in Iraq and Afghanistan as well as our neighbor’s kids was cost-effective. What impact will CER have on future TBI treatments as well as other innovations developed to battle cancer, Alzheimer’s and Parkinson’s?
CER proponents such as Donald Berwick, the administrator of the Center for Medicare and Medicaid Services, believe that most medical innovation increases healthcare spending without adding any benefit. They believe CER can be used to select innovations that can reduce costs without harming patients and free up spending for other purposes.
But CER only looks at the comparative cost of everything from the government’s perspective and the average response to the average person, not the value of innovations to our families and friends. More troubling, CER does not measure the impact of requiring more time, money and clinical trials on the number of innovations or what effect fewer innovations would actually have on our lives.
We conducted such a study. And we found that the added time, cost and regulation could reduce R&D investment by $32 billion over the next decade. That would cost Americans $4 trillion in economic activity and snatch 81 million years of life from our families and friends. Our research confirms the analyses of other economists that an increase in R&D is associated with increases in wealth and longevity. For example, University of Chicago Economists, Kevin Murphy and Robert Topel, estimated the social-economic value of a 10 percent reduction in the mortality associated with cardiovascular disease and cancer around $10 trillion.
CER advocates such as Dartmouth University physician Jonathan Skinner believe that government should pay for any technology that costs more than $50,000 a year. They make no bones about the fact that many innovations would be not paid for under this formula. Skinner believes that “the antagonism toward comparative effectiveness research…suggests a bit of magical thinking — the notion that the country can avoid the difficult trade-offs that cost-utility analysis helps to illuminate…It represents another example of our country’s avoidance of unpleasant truths about our resource constraints.”[1]
In fact, our analysis suggests that the real trade-off isn’t between the government spending money on cancer drugs or pap smears or high speed railways.
Yale University Economist William Nordhaus estimates the value of innovations in medicine during the second half of the twentieth century are about equal to growth in Gross Domestic Product (“GDP”) over the same fifty-year period. In other words, Nordhaus estimates that we could have spent more on food, clothing, entertainment, education, vacations, airplanes etc. and less on medical innovation. But in doing so we would essentially have to accept 1950’s levels of care over the past 50 years.
Our research estimates what spending less on medical progress as a result of CER as another hurdle to developing and using medical technologies. Our study confirms what Nordhaus and others have concluded: “the social productivity of health-care spending might be many times that of other spending. If this is anywhere near the case, it would suggest that the image of a stupendously wasteful healthcare system is far off the mark.” And it suggests that CER is not only misguided, it’s dangerous to our health and quality of life too. That’s the unpleasant truth CER advocates seeming willing to ignore
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.
