Latest Drugwonks' Blog
When it comes to the patient voice at the June 28-29 ODAC meeting on Avastin, silence most certainly does not imply consent
FDA's Karen Midthun, who will serve as presiding officer for the second ODAC hearing on the future of bevacizumab's (Avastin) breast cancer indication, has rejected Genentech’s request to allow members of the public to speak at the meeting.
This seems to be in direct contradiction to statements from CDER Office of New Drugs Director John Jenkins, who has gone on the public record that a crucial piece of risk/benefit assessment is the patient perspective.
"I think it's very important to understand the patients' perspective about how they value the benefits and how they are willing to accept the risk … A lot of us are basing these decisions in the abstract. We don't have the disease, we haven't achieved the benefit, and we do not actually have to weigh, personally, that benefit against the risk."
And further, "Regulators and others may not consider those benefits to be very important, but to the patients, they are extremely important and allowed them to go on about their lives.”
Dr. Midthun’s decision to ban patient comment is also contrary to the spirit of the 11/22/10 PDUFA negotiating session, where the FDA said that information about patients’ understanding of existing treatment tools is considered valuable, but is not consistently available during the review process.
The upcoming “Avastin Meeting” is, in all particulars, the perfect opportunity to take the “patient involvement” hypothesis out for a spin. Why is the agency afraid of what patient groups might say? Or does ODAC simply consider the patient voice not relevant? Advice mustn’t only be sought and considered when it supports your position.
After all, in the words of Dr. Jenkins, “We have to be aware of the societal expectations of how we interpret our standard and how we make our decisions.”
Bad Medicine
Organized ignorance endangers health.
Tevi Troy
Deadly Choices
How the Anti-Vaccine Movement Threatens Us All
by Paul A. Offit
Basic Books, 288 pp., $27.50
Tabloid Medicine
How the Internet Is Being Used to Hijack Medical Science for Fear and Profit
by Robert Goldberg
Kaplan, 336 pp., $25.99
Over the last few months, we have seen the final and decisive disavowal of the work of Andrew Wakefield. Sadly, the damage this man has done is almost incalculable.
More than a decade ago, Wakefield set off a frenzy of fear when he presented “data” in the British medical journal Lancet that cast doubt on the safety of vaccines. Lancet eventually retracted the article, and only recently it was revealed that Wakefield may have had financial incentives to publish his spurious findings. Unfortunately, uninformed citizens, sensationalistic journalists, and opportunistic celebrities continue the momentum of his discredited work—endangering individual lives and our public health. As vaccine advocate and expert Paul Offit has said, “You can’t unring the bell.”
Nevertheless, that is exactly what Offit tries to do in Deadly Choices. Because of the deleterious impact of Wakefield and others like him, this book is a much-needed inoculation to help prevent future public scares. Offit reviews the history of vaccines, their importance, and the various attempts to discredit them over the past few centuries.
According to Offit, Wakefield is not the first anti-vaccine advocate to be thoroughly repudiated. Offit reminds readers of the controversy surrounding the pertussis vaccine, which some charged was a cause of mental retardation. This theory was thoroughly disproven by Samuel Berkovic in 2006, who demonstrated that a very specific genetic mutation caused the retardation in the studied cohort. Nevertheless, as Offit notes, the attack on the pertussis vaccine was a preview of the rules for anti-vaccine radicals—and the aftermath of damage: Despite the Berkovic study, he notes, “Not a single newspaper, magazine, or radio or television program carried the story.”
Offit also tells the tale of the creepy and iconic doll Raggedy Ann, which was created by cartoonist Johnny Gruelle after his daughter Marcella died following a smallpox vaccine. According to Offit, Raggedy Ann’s floppy arms and legs were supposed to signify a child harmed by a vaccination, despite the fact that “the medical report stated that the child had died from a heart defect.”
As these stories show, Offit is clearly frustrated by the superior ability of the anti-vaccine forces to deliver their misleading message with horrifying images or rhetoric. Offit has particular disdain for celebrities like Jenny McCarthy who misuse their fame (such as it is) to frighten parents into not getting their children vaccinated—which is dangerous not only for the children, but for their classmates, friends, and neighbors as well. Particularly irresponsible is
Dr. Mehmet Oz who, despite his medical degree, freely admits that he does not get his children vaccinated because “my wife makes most of the important decisions as most couples have in their lives.” Oz’s wife, like Jenny McCarthy, has no scientific or medical training. Offit also provides a photograph of the happy couple, perhaps to reveal that (also like McCarthy) she has certain external characteristics that may cloud Dr. Oz’s decision-making process.
One thing Offit does not do here is describe the degree to which he has been pilloried and threatened by the anti-vaccine movement for his efforts to show that vaccines are not only safe, but also lifesaving. Enter author and medical expert Robert Goldberg, who tells another vital part of the story in his Tabloid Medicine. According to Goldberg—full disclosure: I know Goldberg socially, but have never met Offit—Offit has been characterized as a “devil,” a “prostitute,” and a “terrorist” for his efforts and has been repeatedly sued. He has also been forced to hire security for his own protection. Yet Offit remains undeterred in his attempt to promote the use of vaccines as a public health measure. As Goldberg notes,
Two things seem certain: Dr. Offit will never pipe down and stop standing up to these instant experts and their supporters, and they will never stop trying to silence him through harassment and intimidation.
Goldberg’s book is broader than Offit’s, as it looks at a variety of antiscience attacks on medical innovation. Goldberg makes the smart observation that the Internet has tilted the playing field in favor of those trying to scare patients, and against those trying to fight frenzied fiction with sober statistics. Although he acknowledges that the Internet has great potential to advance the cause of science, he also notes,
Online information can be alarmist or can over-represent the potential for serious illness or side effects, and many websites represent an agenda that can be at odds with the existing scientific data and distorts contemporary information in a way that is misleading and disingenuous.
Goldberg’s premise is that people are largely incapable of evaluating risk as it applies to them as individuals. (In this, he is influenced by the pioneering work of the late social scientist Aaron Wildavsky and the Nobel Prize-winning economists Daniel Kahneman and Amos Tversky.) According to Goldberg, the Internet exacerbates the situation by highlighting the sensational and burying the mundane, leading not only to anti-vaccine scares but also “cyberchondria,” the mistaken belief that one is exhibiting symptoms read about on the Internet. This is not dissimilar to “medical students’ disease”—in which med students imagine they are coming down with the conditions they are learning about in the classroom—but far more dangerous as it potentially affects the entire online population.
Goldberg notes that there are smart, science-based writers out there who can counteract the scaremongering, but they are too often subjected to variations of the attacks that Offit has encountered. One of the most frequent assaults against advocates for sound science is that they are shills for industry. Critics insinuate or accuse them of having conflicts of interest because they have worked for or with pharmaceutical companies or for organizations with ties to pharmaceutical companies. This charge is so broad it probably includes every research university in the country as well as the entire federal government. According to Goldberg, the movement to expunge any potential “conflicts of interest” from scientific study is one with an ulterior motive: to squelch debate and take anyone who has worked with, near, or for pharma out of the game.
We can be thankful that Robert Goldberg and Paul Offit have repeatedly shown the courage to defend the integrity of the scientific process, often at personal and professional risk. These two experts have provided valuable insights into the fractured way our public debate is taking place and the grave potential consequences Internet and media irresponsibility can have for the public health.
Tevi Troy, senior fellow at the Hudson Institute, is the former deputy secretary of health and human services.
To paraphrase the late Dr. Martin Luther King, Jr., “There comes a time when people get tired … and we have no alternative but to protest.”
There has been a lot of moaning and groaning about the FDA’s continued delay in releasing social media guidance. As if it matters. Various DDMAC panjandrums have consistently said that what regulated industry marketers want most, predictable “how to” guidelines relative to specific platforms (FaceBook, YouTube, Twitter, etc.) is not on the docket nor is direction on adverse event discovery, reporting, or responsibility. Expecting a regulatory Holy Grail will only lead to disappointment and frustration. And blaming the FDA when that happens won’t make anything better or move the social media agenda ahead any further or faster.
Social media for regulated industry is a greenfield of opportunity. But to maximize the opportunity, we must accommodate the reality of a messier world. Social media, almost by definition, is messy – and the regulatory framework (or lack thereof) is equally so. And it’s not likely to get much better.
Embracing social media means embracing regulatory ambiguity. And that’s a paradigm shift for an industry that has (in a post-Vioxx world) been going in precisely the opposite direction. Social media (and its game-changing opportunities) demands a move away from the cautious tactics of the Vioxx Populi towards a better understanding of the digital Vox Populi.
Nobody said it was going to be easy. And marketers have to get used to it if regulated marketing is going to succeed and thrive in the 21st century. And that means more than sponsored Google links and branded FaceBook pages with the interactivity turned off. It means mixing it up with real people in real time. It’s not going to be easy, or risk-free, or inexpensive. And whatever social media “marketing models” companies build will have to be elastic – just like the media environment in which they are designed to operate.
The most constructive “podium policy” from the FDA (in this case from Jean-Ah King, special assistant to DDMAC Director Tom Abrams) has been, ““The bottom line is this is a regulated industry, and if you choose to do promotion in that area (social media) just make sure that at the end of the day what we’re looking at is in the best interest of public health.”
Obvious – but important to remember. And, in the words of Winston Churchill, “Ease is relative to the experience of the doer.”Here is the actual FDA statement on it’s pending social media guidance:
“It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or ‘Good Guidance Practices' (GGPs), which ensures that FDA's stakeholders are provided well vetted guidances articulating FDA's current thinking on a topic.”
And here is the much more amusing April Fool’s version from the creative minds over at Medical Marketing & Media Magazine:
DDMAC social media guidelines include "dislike" button for bad ads
The FDA surprised the industry by rolling out detailed social media marketing guidance and a beefed up “Bad Ad” program that will use crowdsourcing to inform federal formulary access decisions.
Just days after announcing it would miss a second deadline for the hotly anticipated draft guidance, the agency reversed course. At a hastily assembled press conference Friday morning, Division of Drug Marketing, Advertising and Communications director Tom Abrams outlined the new policy.
The theme of DDMAC's Good Guidance Practices, said Abrams, is "Back to the future."
"We believe that companies can best offer truthful, non-misleading and balanced information on regulated products through proven technology until those products are themselves proven," said DDMAC's Jean-Ah Kang. "Meaning that they've been on the market for, say, 13 years or so."
Accordingly, DDMAC will now require that all web pages for branded prescription pharmaceutical products be optimized for the Netscape Navigator browser. Pharmas, the agency said, may provide information about their products on Friendster, though not on Facebook, Twitter, YouTube, Orkut or even MySpace.
A "dislike" button, inspired by the agency's "Bad Ad" program, will be required for all content deemed promotional, and the data generated will inform the Independent Payment Advisory Board's recommendations for Medicare coverage. Search ads for regulated products will be required to carry a tag in flashing red script reading "WARNING! This site may harm your computer!"
In keeping with that guidance, the agency unveiled a revamped website with what Abrams hailed as a "cool retro-'90s look." A polka band played a cover of Nirvana's "Smells Like Teen Spirit" as Abrams fiddled with Powerpoint slides of the site.
Abrams fired a warning shot to marketers looking to imitate the behavior of “today's youth” in their digital communications. “Regulated industries should refrain from ‘sexting,' whatever that is,” he declared. “It just sounds nasty. Don't do it."
As predicted by MM&M back in February, Abrams named former Propecia marketer and viral videotrepreneur Kevin Nalty to lead a new division dedicated to policing online marketing.
"The Internet is great for porn, toilet humor and cute pictures of small, furry animals," said Nalty, "but disseminating information about prescription drugs? People, trust me -- stick to fart jokes and we'll all get along just fine."
From the pages of BioCentury:
Republican bill seeks to ban comparative effectiveness
Sens. Jon Kyl (R-Ariz.) and Mitch McConnell (R-Ky.) introduced a bill that would prohibit the U.S. government from using comparative effectiveness research to deny or delay coverage of healthcare treatment to a patient based on cost. The Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2011 (S. 660) was referred to the Committee on Health, Education, Labor and Pensions. The bill was co-sponsored by Sens. John Barrasso (R-Wyo.), Tom Coburn (R-Okla.), Mike Crapo (R-Idaho) and Pat Roberts (R-Kan.).
And from the “I'm shocked, shocked to find that gambling is going on in here” department:
WASHINGTON (AP) -- AARP lobbied for the new health care law and now it stands to profit, Republican lawmakers charged Wednesday as they called for the IRS to investigate whether the powerful interest group representing millions of older Americans should be stripped of its federal tax exemption.
Three veteran GOP representatives released a report that estimates the seniors lobby could make an additional $1 billion over 10 years on health insurance plans whose sales are expected to pick up under the new law. They also questioned seven-figure compensation for some AARP executives.
The report found that insurance sales are AARP's single largest source of revenue. AARP-brand offerings are the market leaders for Medicare prescription coverage, private Medicare Advantage insurance plans, and Medigap coverage that fills in benefit gaps for people with traditional Medicare.
UnitedHealthcare, which operates the AARP plans, paid the organization $427 million in 2009, according to the report.
The Ways and Means Committee has scheduled a hearing Friday on AARP's structure and finances.
According to a report in the Washington Post, “Medicaid, the joint federal-state health program for the poor, spent $329 million extra in 2009 purchasing 20 brand-name drugs instead of available generic copies, according to an American Enterprise Institute report.”
The spending numbers are iffy. The word “extra” is wrong. And words matter. A lot.
The Post writes, “The study included contraceptives, respiratory medicines and antibiotics. Risperdal, New Brunswick, N.J.-based Johnson & Johnson’s antipsychotic, prescribed in generic form exclusively would have saved $60 million in 2009, the report released Monday found.” It’s important to note (and is mentioned in the Post story) that Teva (the world’s largest generic drugs company) makes a generic version of the drug.
Two things for starters. First, nowhere in the Post story (or, even more surprisingly, in the AEI paper) does it mention that the report’s author receives monetary support from Teva. Whatever happened to the urgency of transparency? That’s a big oops.
Secondly, and more importantly from a therapeutic perspective, generic substitution, while a good way to save payers money in the short term (including our nation’s largest payer – Uncle Sam), often has quite deleterious impact on patient care -- an issue that is well researched and quantified and entirely absent from both the AEI report and the Washington Post reportage.
And this is even more important when it comes to medicines that have a narrow therapeutic index – such as Risperdal.
According to the FDA, narrow therapeutic index means that "small changes in blood concentration have the potential to result in serious therapeutic failures and/or serious adverse drug reactions." The AEI paper not only ignores this issue, but openly shills for more aggressive therapeutic substitution (as a way to save money) without ever once mentioning the very real such a policy would have on patient care.
(Currently, the "sameness" of a brand product and a generic version is evaluated based on two-treatment crossover study to prove bioequivalence, the aim being to show that the 90 percent confidence intervals of the geometric mean test/reference ratios for both maximum plasma concentration and the area under the plasma concentration-time curve fall within a range of 80 percent to 125 percent.)
In fact, this is such an important issue, that at recent meeting of the Generic Pharmaceutical Association, CDER Director Janet Woodcock said that the FDA is discussing tightening the equivalence limits of generic medicines "so there is less variability. And the agency’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee concluded (in an 11-2 vote) that current bioequivalence standards are not sufficient for narrow therapeutic index drugs.
Mention of this in the AEI report? Zero. Mention of “millions of dollars in potential savings? Multiple. Mention of author’s financial relationship with the world’s largest generics manufacturer? None.
The Post reports that, “the top-20 list of drugs Medicaid overspent on in 2009 includes five anticonvulsants.” And that the “estimated waste” cited by the report on the five treatments totals $169 million. The Post finally admits that these medicines “are under Food and Drug Administration scrutiny because of patient and provider concerns that generic versions don’t work as well to treat epilepsy as their brand-name counterparts.”
Thank you. On a personal note, my eldest son has epilepsy – so this issue is both professional and personal for me.
How’s that for transparency?
The report’s author, per the Post, “said he couldn’t comment on whether generics should be substituted for anticonvulsants. “We have to leave it to the FDA to determine what’s interchangeable.”
Alas – that too is lacking from the pages of the report.
The major point of discussion was: Why did the media fail so miserably in covering the vaccine-autism link and why was it willing to give junk and pseudo science a platform?
No one answer was provided. However it is clear that the motivations and approach of journalists that perpetuated this false narrative is alive and well. The participants made the following points:
1. Health care journalists limit their focus on conflicts to specific industries and give those ‘experts’ who raise questions about the integrity of companies, who claim links between chemicals and disease and who identify the profit motive as inherently evil are free pass. Here are one recent example: FDA Probes Link Between Food Dyes, Kids' Behavior
2. Health care journalists ignore all ‘conflicts of interest’ except when it comes to medical product companies. For instance, a story in Reuters claiming if doctors prescribed more generic drugs there would be more compliance and less spent on medications. It was based on a study conducted by CVS and Harvard professors who claimed no financial interest. The authors are: an executive of CVSCaremark, a doctor running CVS Caremark Harvard Partnership for Improving Medication Adherence and another making money doing academic detailing. The authors did not disclose this association or were not required to. Even health care journalists are guilty of this deliberate oversight: Joanne Kenen’s bio on the Health Journalism blog leaves out her long affiliation with the left-leaning New America Foundation.
3. Health care journalists continue to ignore the body of science in covering a study. The Reuters article is a case in point: The totality of evidence regarding the impact of generic drugs in improving adherence is unclear at best because most studies do not measure the impact of switching to a generic on compliance. Such studies, with rare exception, fail to look at total treatment costs in specific therapeutic areas. Finally, there is a body of evidence demonstrating that “allowing people to use only generic drugs would increase total treatment costs, not reduce them, and would lead to worse outcomes.”
More here.
Similarly, coverage of the food color-ADHD ‘connection’ has ignored several large studies and a European Food Safety Agency review harshly criticizing the small ‘studies’ for the same reasons Wakefield’s MMR-autism ‘research’ was trashed.
More here.
The following blog post shows how an unbiased journalist would critically cover this story.
All of which leads me to conclude that health care journalists need to be more vigilant in correcting those in the field. There is nothing wrong and indeed much to admire in reporting or coverage with a strong point of view or bias. I don’t think journalists should be penalized for having a particular bent or expressing opinions on most subjects. At the same time it is wrong to apply a double standard on conflicts, (which will be the subject of another post) fail to do a 5 minute search of well-designed studies that have clear endpoints or subject a medical or scientific claims about risks to the scrutiny of clear, replicable evidence. Finally, journalists and headline writers have to stop framing possible associations as causation.
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.
