Latest Drugwonks' Blog
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
Mistakes are the portals of discovery.
James Joyce
In a wise reversal, the FDA will now allow two hours of open public testimony during the first day of the (June 28-29) Avastin hearing.Smart.
In further news, ODAC will vote on the fate of Avastin's breast cancer indication at the agency's hearing on the proposed withdrawal of the claim, marking the third time in four years that the panel has been formally polled on whether the VEGF inhibitor should be used in this population. It voted against approval the previous times.
The announcement that ODAC will have a voting role contrasts with CDER’s original expectation that committee members would be asked to provide advice and recommendations but not vote.
Karen Midthun explains that since this is an administrative hearing, procedures will differ from those of a typical advisory committee meeting and may bear more resemblance to a court case.
According to Karen, "It may help to think of this as, in some ways, like a trial." Representative and will lead the meeting. Panel members will have an opportunity to question witnesses appearing on behalf of Genentech and CDER.
"As with a typical advisory committee meeting, we will ultimately ask you to vote as a committee on the issues that are the subject of the hearing," the letter states. "There will not be an immediate decision by FDA at the hearing. Instead, as with an advisory committee meeting, FDA will consider the committee's input and will announce its own ultimate decision at a later date."
The Pink Sheet opines that, “The decision to give ODAC a voting role would seem to bode ill for Genentech in light of the panel's previous negative reviews of bevacizumab for MBC.”
But there’s a third option other than yea or nay. FDA is leaving an opening for Genentech to hold on to Avastin's metastatic breast cancer indication even if Commissioner Margaret Hamburg determines existing evidence has not demonstrated bevacizumab's efficacy or safety for this use.
Commissioner Hamburg can decide to retain bevacizumab's accelerated approval in first-line MBC while the company conducts additional studies to confirm clinical benefit even after determining that the grounds for withdrawing the claim have been met.
The Pink Sheet reports that Roche/Genentech is seeking a broad label in metastatic melanoma for the just-filed oral BRAF inhibitor vemurafenib (formerly PLX4032) and priority review, which could possibly enable a U.S. launch at the end of 2011.
It's geared as a treatment for the roughly half of metastatic melanoma patients who test positive for the BRAF V600 mutation. A companion diagnostic to test for the mutation has been developed by Roche Molecular Systems, and has also been submitted for approval.
As a personalized therapy for the tough-to-treat disease, the drug has been widely described as a game-changer in melanoma.
Drug companies should not let overeager sales representatives make do-it-yourself Web videos and post them online without review by compliance experts.
Duh.
Warner Chilcott received for a notice of violation letter for a sales-rep-created-and-produced YouTube video promoting its new osteoporosis drug Atelvia (risedronate delayed-release), which featured a female sales representative talking about the drug to an enthusiastic staff member in a physician's office.
The letter was generated by a "Bad Ad" program complaint, and FDA noted that the video was never submitted via a FDA Form 2253 as required.
Oops.
According to the May 5 NOV letter to Warner Chilcott, which was posted to the FDA Web site May 9, "The video was posted by the sales representative on the website YouTube.com under the direction of a Warner Chilcott district manager."
Please note that this does not mean that YouTube is out of bounds. It's not the channel that's non-compliant, it's the content.
Sins of omission are seldom fun.
Reporters interested in scheduling an interview with the authors of the report should contact CMPI Vice President Bob Goldberg at robert.goldberg@cmpi.org
From the Forest from the trees department, The Wall Street Journal reports:
A federal trial judge on Tuesday acquitted a former GlaxoSmithKline PLC lawyer in a high-profile corporate misconduct case, dealing a blow to the government's effort to target individuals in probes of the pharmaceutical industry.
U.S. District Court Judge Roger Titus in Maryland took the rare move of acquitting former Glaxo lawyer Lauren Stevens without sending the case to the jury.
Judge Titus called his summary move to acquit Ms. Stevens a first in his seven-and-a-half years on the federal bench. "The defendant in this case should never have been prosecuted and she should be permitted to resume her career," he said.
Prosecutors had alleged Ms. Stevens obstructed a Food and Drug Administration investigation into whether Glaxo had improperly promoted the antidepressant Wellbutrin for weight loss, a use not approved by the FDA.
The government's defeat points to the difficulty of prosecuting individuals over alleged wrongdoing at large corporations, where teams of people may be involved in a matter and it is hard to show that executives intended to break the law.
Despite calls for prosecution of top Wall Street figures in the wake of the 2008 financial crisis, the Justice Department has brought only a handful of cases against individuals, and lost some prominent cases.
Ms. Stevens's sudden acquittal could hurt other government efforts, including the long-running investigation of Glaxo for marketing issues related to several drugs, said defense attorneys. They said the Justice Department and the Department of Health and Human Services may have to review their larger strategy of targeting executives and lawyers at pharmaceutical companies.
The Justice Department cannot appeal Tuesday's acquittal. "We believe these charges were well-founded and that the jury should have been allowed to deliberate and decide this case," a department spokesman said.
Pharmaceutical companies have paid billions of dollars to settle various marketing-related charges with the government, but only a few executives have pleaded guilty to any crimes.
Government officials have said they decided to go after more individuals to create a stronger deterrent and prevent companies from viewing fines as merely "a cost of doing business."
Prosecutors alleged Ms. Stevens falsely denied that the company had promoted Wellbutrin for unapproved or "off-label" uses, despite knowing that the company had sponsored programs with doctors' groups involving Wellbutrin. Companies are barred from off-label marketing but doctors can generally prescribe an FDA-approved drug for any condition.
Defense lawyers for Ms. Stevens said she provided legitimate and zealous representation of Glaxo and relied in good faith on the advice she received from an outside law firm.
The judge agreed, saying it would be a "miscarriage of justice" to let the case get to the jury.
"We did not have a bad five minutes in that courtroom; if it had been a prize fight, they would have stopped it," said Ms. Stevens's lawyer, Reid Weingarten, who has represented Cabinet secretaries and corporate chiefs.
It is rare for the government to charge a lawyer over advice given to a client, because such conversations are generally protected unless the lawyer is helping the client commit a crime.
Judge Titus's ruling is likely to make such prosecutions rarer still. "There is an enormous potential for abuse in allowing prosecution of an attorney for the giving of legal advice," the judge said.
The government has long been investigating Glaxo over various allegations related to sales of antidepressants Paxil and Wellbutrin, as well as its former popular diabetes drug Avandia. Glaxo hasn't been charged with wrongdoing in these cases, but the investigation is continuing, according to people familiar with the matter.
Its outside counsel, King & Spalding LLP, didn't return calls requesting comment.
The government hasn't said whether the prosecution of Ms. Stevens was part of an effort to push Glaxo into a plea deal. It said in court documents in December that the Stevens case was part of an "ongoing underlying health-care fraud investigation" looking at her and "potential criminal activity by others."
The company has declined to comment on the cases, and it hasn't said under what terms Ms. Stevens left the company last year.
It said Tuesday that it was "pleased" with her vindication.
"The acquittal certainly strengthens Glaxo's hand in negotiations with the government about a corporate resolution of their case," said John Fleder, a defense attorney with Hyman, Phelps & McNamara PC who wasn't involved in the case.
FDA officials and the inspector general of the Department of Health and Human Services have said that the government wants to make more use of an administrative option to punish executives by excluding pharmaceutical company leaders from the industry. That option may look more attractive after the failure of the criminal case against Ms. Stevens.
Companies that employ an "excluded" executive can be prevented from selling products to the U.S. government—which almost all pharmaceutical firms do. In essence, the step can force a company to dump its chief in order to do business with Medicare or the Veterans Administration.
In April, the HHS inspector general created a firestorm in the drug industry when the agency said it intends to exclude the longtime chief executive of Forest Laboratories Inc, Howard Solomon. The company has protested the move and said Mr. Solomon had nothing to do with marketing violations for which the company agreed to pay more than $300 million in civil and criminal fines.
Gary Schwitzer's HealthNewsReview Blog (fully funded by the for profit HealthDialog, a point I raise only because Schwitzer makes a federal case about pharma funding of researchers) runs healthnewsreview.org. He has never found a new drug or treatment worth paying for. Which raises the question of whether or not he would accept the state of medicine in 1980.
Given the guest blog by "Harold DeMonaco, director of the Innovation Support Center at the Massachusetts General Hospital and one of Schwitzer's most active expert story reviewers on HealthNewsReview.org, my guess is he would be delighted to have stopped progress in it's track in 1980. DeMarco said: "Can we afford to continue to pay for treatments that provide what many would call a marginal benefit? Can we afford not to? Although the increase in survival was only 4 months (from 21 months to 25 months), some men survived longer."I am shocked at how uninformed the rant against Provenge and other medical breakthroughs was. In 1980 the average cost for treating colon cancer was $20K, about $42K in 2010. In 1980 the average five year survival rate for colorectal cancer was 50 percent for people age 45 and over among patients whose cancer had spread to lymph nodes Today the average cost of colon cancer therapy is $40K with a 5 year survival rate at a similar stage is 70 percent. The age-adjusted death rate was 17.6 per 100,000 men and women per year. These rates are based on patients who died in 2003-2007 in the US.
Advances in interceding years provided, as you described Provenge (which has extended the life expectancy of end stage prostate cancer patients by 2 years) marginal benefit. That’s on top of a decline in mortality rates from previous treatments and increase screening.
David Cutler noted that “age-adjusted cancer mortality increased by 8 percent between 1971 and 1990, twice the increase from 1950 through 1971. However, between 1990 and 2004, age-adjusted cancer mortality fell by 13 percent. This drop translates into an increase in life expectancy at birth of half a year--roughly a quarter of the two-year increase in life expectancy over this time period and a third of the increase in life expectancy at age 45.” Similarly, Murphy and Topel estimate that a 1 percent reduction in cancer mortality would be worth $500 billion. Since the death rate from prostate cancer has decline by 37 percent since 1992, the worth of that reduction is $18 trillion.
So would you not have spent more money on increasingly more expensive drugs because at that point in time the benefits were marginal.
That begs the question: would he forfeit the gains in health derived by increased screening and better drugs over the past 30 years to buy more of the kind of cancer care we had in 1980. Or his just willing to forfeit gains going forward.
I will let Fox News' Jim Pinkerton who also runs the Serious Medicine Strategy blog introduce our new paper on the human cost of comparative effectiveness research:
Editor's Note: This is an important piece on Comparative Effectiveness Research from the Center for Medicine in the Public Interest, a leading voice in the struggle to improve our national health through the expansion of personal freedom and the advancement of Serious Medicine."
seriousmedicinestrategy.blogspot.com/
Our thanks to Jim Pinkerton for taking our research so..seriously!
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.
