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From the good folks at Inside Health Policy

Senators Question FDA's Authority To Use 'Placeholder' Biosimilar Name

Senate health committee chair Lamar Alexander (R-TN) led a group of Republican senators in expressing anxiety about unresolved questions concerning FDA's implementation of the biosimilar pathway, saying the agency's “failure” to resolve fundamental questions -- such as naming -- before approving the first biosimilar last month “raises a number of serious concerns.” The senators especially take aim at FDA's authority around using a “placeholder” name for the first biosimilar approved in March.

 The lawmakers say: “FDA has not provided sufficient guidance on important issues relating to the review and approval of license applications for biosimilar products, such as naming, interchangeability, and production of patent information.”

 Alexander was joined by Republican Sens. Michael Enzi (WY), Richard Burr (NC), Johnny Isakson (GA), Mark Kirk (IL), Orrin Hatch (UT), Pat Roberts (KS) and Bill Cassidy (LA).

The lawmakers especially question FDA's use of a “placeholder” name for the first approved biosimilar -- Sandoz's filgrastim drug product, which carries the placeholder name filgrastim-sndz.

 “It is unclear to us what it means for a nonproprietary name to be a 'placeholder,' what authority FDA has to make such a designation, or what treatment a 'placeholder' name will receive once FDA formalizes a naming policy,” they say. “In addition, we are concerned that hospitals, consumers, patients, doctors, and others may be confused by a name that appears temporary or not fully approved.”

 The senators ask FDA a series of questions regarding its implementation of the Biologics Price Competition and Innovation Act, including questions for clarification around what a “placeholder” nonproprietary name is, what the process is for changing such a name and the estimated economic impact of such a change.

They further ask what guidelines FDA staff members have been following in reviewing biosimilar applications, and whether staff members have been instructed to either follow or not follow recommendation in any of the draft guidance documents that FDA has published.

 Additionally, the lawmakers inquire as to what circumstances FDA considers necessary for a biosimilar product to disclose in its labeling that it has or has not been found to be interchangeable with the reference product or other biosimilar products that share the same reference product. “Why did FDA (a) withdraw the draft guidance it published on this issue and (b) approve labeling for a biosimilar product that contains no such disclosure?” ask the senators.

 They ask FDA to list the guidance documents regarding biosimilar or interchangeable products FDA currently intends to publish and on what timeline. FDA's drug center guidance agenda includes five planned guidances for 2015, including: additional questions and answers regarding implementation of the BPCIA; considerations in demonstrating interchangeability; labeling for biosimilar biological products; nonproprietary naming for biological products; and statistical approaches to evaluation of analytical similarity data to support a demonstration of biosimilarity.

 The lawmakers also wonder why FDA has declined to provide guidance regarding whether the so-called patent dance provisions in the pathway are mandatory. A court decision out of the U.S. District Court for the Northern District of California last month ruled that the provisions were optional. The case is now on appeal and set to be heard June 3.

 Finally, the lawmakers what to know how FDA is communicating with and educating patients in regards to biosimilars, including issues such as biosimilarity, extrapolation and interchangeability.

 “We also urge FDA to prioritize the publication of final guidance on the issues identified above, and to improve the transparency of its biosimilar review and approval process going forward,” state the senators.

Per a report in BioCentury, the FDA has added to its agenda of new and revised draft guidances that its Center for Drug Evaluation and Research (CDER) intends to publish in 2015 an item titled "Nonproprietary naming for biological products," intended to clarify the agency's thinking on biosimilar naming.

Stay tuned.

FDA could approve drugs for new uses on less data: draft law

 (Reuters) - Draft U.S. legislation released on Wednesday could make it easier for drug companies to win Food and Drug Administration approval of products for new uses.

Currently a company with a drug approved for lung cancer must conduct additional studies if it wants to market it for breast cancer.

A bill drafted by the House Energy & Commerce Committee's health panel would eliminate the need for randomized, controlled clinical trials, the gold standard for assessing whether a product is safe and effective.

Instead companies could submit data from observational studies, in which researchers have no control over the experiment, ongoing surveillance studies and other clinical experience.

"Calling for the FDA to use this data is pretty revolutionary," said Peter Pitts, a former FDA associate commissioner for external relations and co-founder of the industry-funded Center for Medicine in the Public Interest. "In the past this kind of data was not considered gold standard."

If included in the final version of the bill, known as 21st Century Cures, "it really would allow the FDA to have a broader view of how the drugs work in the real world," he added.

In addition, the FDA would be allowed to approve new indications based on a review of clinical data summaries, rather than full packages, potentially speeding up the approval time.

The bill would also require the agency to consider using real world experience as opposed to randomized trials to support or satisfy requirements for post-market studies.

The FDA frequently approves drugs based on "surrogate" endpoints that are expected to reflect clinical benefits. If a drug causes a tumor to shrink there is an expectation it could also delay progression of the disease or prolong life.

But companies are required to conduct additional trials to confirm that the expected benefit actually materializes. The bill would reduce the need for such trials.

It would also make it easier for companies to provide economic analyses to insurance companies and others involved in reimbursement. A company with a high-priced drug might want to show why it is more economical than others in the long run.

A prior version of the bill was circulated for discussion earlier this year. A parallel bill is being developed in the Senate.

The second iteration of the 21st Century Cures discussion draft comes with some added attractions – most specifically a bi-partisan authorship.

Hill chatter made it clear that Rep. Frank Pallone was holding back any “D” support until the draft called for additional NIH funding. And, lo and behold, that language is now Title I -- front and center. Whether or not that’s a boondoggle is another discussion (for another time).

As to the actual updated discussion draft, it’s better than its predecessor in many ways, not the least of which is its recognition of the FDA as part of the solution rather than part of the problem -- and that real world data should play a role in informing agency decisions. Efficacy and effectiveness.

Some items of particular interest:

Section 1121: Clinical Trial Data System

This section would create a third party scientific research sharing system for trials solely funded by the federal government in order to allow the use and analysis of data beyond each individual research project.

Section 1141: Council for 21st Century Cures

This section would establish a public-private partnership to accelerate the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients.

Section 2001: Development and Use of Patient-Experience Data to Enhance Structured Risk-Benefit Assessment Framework

Because no one understands a particular condition or disease better than patients living with it, this section would require FDA to establish a structured framework for the meaningful incorporation of patient experience data into the regulatory decision-making process, including the assessment of desired benefits and tolerable risks associated with new treatments.

Section 2062: Utilizing Evidence From Clinical Experience

This section would require FDA to establish a program to evaluate the potential use of evidence from clinical experience to help support the approval of a new indication for a drug and to help support or satisfy post-approval study requirements. In parallel, FDA would identify and execute pilot demonstrations to extend existing use of the Sentinel System to support these efforts.

Section 2082-2083: Expanded Access

This sectionwould place transparency requirements on certain drug companies regarding their expanded access programs (programs for patients to access drugs before they are approved) and require FDA to finalize guidance regarding how it interprets and uses adverse drug event data resulting from drug use under such expanded access programs.

Section 2101: Facilitating Dissemination of Healthcare Economic Information

This section would add  clarity and facilitate dissemination of healthcare economic information, as defined in the section, to payers, formulary committees, or other similar entities.

Section 2263: Reagan Udall Foundation

This section would ensure that the Reagan Udall Foundation has access to the expertise and human capital it needs to fulfill its statutory mission of advancing FDA’s scientific priorities.

The full draft can be found here.

The section-by-section draft can be found here.

And the one-pager here.

Many items of interest – and the devil is in the details. Stay tuned.

United Health Takes Novel Approach To Controlling Access To New Medicines

From The Hill:

UnitedHealth to Congress: Let cancer patients eat gauze
By Jonathan Wilcox

Investors are cheering the news that UnitedHealth Group, the nation’s largest health insurer, reported first quarter 2015 revenues of almost $36 billion, a 13 percent increase from last year that “beat the street” by exceeding forecasts.  The company said revenues are expected to reach $143 billion this year, and specifically credited “more effective and more modern approaches” for the windfall.

What are UnitedHealth’s “more effective and more modern approaches”?  Stripped of the self-congratulatory press releases, this dividend translates into something more worrisome for the tens of thousands of cancer patients dealing with rising copays, restricted coverage and all too often, access denied completely.

That’s why cancer advocacy organizations are taking action, pressing Congress and state legislatures to cap co-pays on specialty medicines and ensure equality of access and insurance coverage for all anticancer regimens.  To date, 39 states have enacted oral chemotherapy access laws, while 15 states and the District of Columbia have either introduced or passed bills to limit what patients pay for specialty medicines. 
Ask patients where these actions are necessary and you’re likely to hear about the detested practice of health plans requiring patients to use medication after medication until their insurance company agrees to pay for the drug actually prescribed by their doctor.  Insurers have a benign term for this: “step therapy.”  But cancer advocacy organizations call it something else: “fail first.”

Not only is this practice unjust, multiple studies show it increases costs to the health care system – particularly for hospital and emergency-room care — while compromising patient treatment.

Another onerous strategy is placing newer medicines (especially biologics) into “specialty tiers” – another dressed-up code word for patients having to pay up to 50 percent of the total cost of these therapies.  This can cause patients to spend thousands of dollars for a single drug that is medically necessary, opt for less effective drugs or choose not to fill their prescriptions at all. 

Then, there is the ritual of insurers covering the costs of intravenous or injectable chemotherapy drugs when patients are treated in a physician’s office or hospital, but not a major portion of the costs when patients take oral cancer drugs at home.  The insurance preference for invasive infusions and harsher side effects is simply unfathomable to many patients.

According to the latest estimates, as much as 25 percent of oral anticancer medicine costs is shifted to patients in higher co-pays – as much as hundreds or thousands of dollars per month.  As a result, almost 10 percent of insured patients don’t fill their initial prescriptions for these medications.  They want to – they just can’t afford to.  

Ten percent of cancer patients denied access to treatments their doctors prescribe and they need is no rounding error – it’s a national crisis. 

Despite these facts, UnitedHealth and other insurers are blocking patients’ path to novel therapies because they say the price of new, targeted medicines is “not sustainable.”  This may make short-term sense for the bottom line and the stock price, but it is hurting patients and damaging the broader economy.

But there is a simple solution for UnitedHealth and other health plans to solve this crisis. According to an analysis released last month by the Millman financial consulting firm, capping copays for many plans would increase premiums by less than 0.5 percent. For other plans, there are market-based ways to offset costs by increasing the copays for doctor visits by just $5.

These solutions also pay back: According to one analysis, innovative treatments and breakthrough cancer medicines are associated with 50 million life years saved over the last 15 years.  The improved outcomes and increased survivability have reduced spending on hospital and physician care, amount to an economic gain of $1.2 million per person, and countless additional tax payments as employees live and work longer.   

Right now a patient revolution is going on in this country, but it need not be at war with the insurance industry.  By all means, let UnitedHealth grow its business and expand its bottom line.  We don’t want to take away the insurance industry’s profits – all we ask is that while doing very well from patient premiums, insurers do some good for patient access, too.

Wilcox is the Public Policy director of Vital Options International, a national non-profit organization focusing on improving the lives of all Americans living with cancer. He is a fellow with the University of Southern California’s Unruh Institute of Politics and was a speechwriter for California Gov. Pete Wilson (R).

FDA has released three final guidance documents on biosimilars but left for later its regulatory answers on requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics. 
FDA will address these issues in a separate draft guidance. The agency does not have an estimated timeline for when the document will be released.

The agency released final guidances covering scientific and quality considerations in demonstrating biosimilarity. The document on scientific considerations includes additional information on study design, endpoint selection and appropriate patient populations for a comparative clinical trial. 
The guidance also clarifies what factors to consider when assessing whether products are highly similar, including expression system, manufacturing process, impurities, reference product and reference standards.

The agency also issued a guidance providing questions and answers on biosimilars, which explain how sponsors can justify extrapolation from a single indication to support approval for additional indications on a reference product's label. The document indicates that sponsors should avoid extrapolation from indications for which the reference product has obtained accelerated approval but has not yet demonstrated clinical benefit in post-marketing trials. 

The Q&A also includes FDA's expectations for the submission of pediatric study plans and outlines justification that should be provided by a sponsor to use comparative data with a non-U.S.-licensed product to support an application to FDA.


Yesterday, CDER Director Dr. Janet Woodcock suggested to the Senate health committee hearing on the Innovation for Healthier Americans Initiative that developing new biomarkers and clinical trial networks, among other strategies, could help improve the drug development process.

“There are other areas in which we hope to work with you as well, including modernizing drug manufacturing, encouraging the development of new antibiotics, and improving the processes for FDA review of drug/device combination products,” said Woodcock in her testimony. She also said drug development could be improved by harnessing evidence from clinical experience, such as through FDA’s Sentinel Initiative, and strengthening patient engagement.

Absent from Woodcock's testimony were controversial measures, included in the first draft of the House Cures bill, that would dramatically revamp current clinical trial design and provide new market exclusivity incentives to a broad swath of drug products. These proposals have been sharply criticized by consumer advocates and some congressional Democrats. “As we say in medicine: First do no harm,” Woodcock said. She also warned lawmakers that giving the agency’s drug center a “large number of unfunded mandates” would cause review performance to suffer.

Woodcock suggested using clinical trial networks and master protocols as a way to reduce clinical trial costs. She said: “First, the cost of clinical trials continues to grow and is the greatest source of cost increases in medical product development. Today, developers of a new medicine spend many millions of dollars planning a clinical trial, developing an elaborate trial infrastructure, finding and enlisting investigators, conducting the trials, and managing the trial data. Each time a new drug is tested, the process is repeated, at great expense, only to dismantle the infrastructure when the study is completed.”

She also advocated improving the science of biomarkers, which are used as indicators of health or disease, or in assessing the response to a therapeutic intervention. Biomarkers have many uses in drug development, according to Woodcock, such as performing safety monitoring, selecting appropriate patients for clinical trials, and selecting therapy for treating specific patients. “However, biomarkers based on new scientific understanding have been slow to come into clinical use, largely because the evidence supporting their validity has been lacking.”

Senate health committee chair Lamar Alexander (R/TN) told Woodcock he welcomed her suggestions. “We would like to invite you to give the bipartisan working group that [Sen. Patty Murray (D/WA)] and I have formed specific suggestions from your agencies about what we can do to enable you to do your job. We don’t want to produce a bill that reduces your productivity, we’d like to increase it,” he said, adding the timing for that feedback would be in the next few months. He also said that funding would be discussed by the Appropriations Committee and to some extent in the health committee.

Rocky Mountain High

  • 04.28.2015

Did Dr. Tim Byers (University of Colorado Cancer Center) present (at the April meeting of the American Association for Cancer Research) “new evidence” that some people get more cancer while on vitamins? On the face of it, this doesn’t sound like a tough question.

At a session entitled “Dietary Supplements and Cancer Risk and Prognosis” Dr. Byers presented information from his 2012 commentary in the Journal of the National Cancer Institute, Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms (May 2012). It’s an interesting and important read – but is it new?

Well, it seems that question depends on who you ask. According to CBS News, “new research finds…” and according to a leading British newspaper, the Daily Mail, “a new study has found …”

The media’s interest in Dr. Byers’ research came about via a standard (and accurate)  university press release. How does the University PR representative feel about the success of the story?

Garth Sundem (University of Colorado media relations department) said he was surprised to see that his news release was “immediately and aggressively sensationalized” by the media, and described a “ripple effect, almost like a game of telephone tag, where news outlets, especially in the UK, seemed to give increasingly more sensational accounts of the study without ever going back to the original source.” He described Byers as being “just as horrified as you’d expect any academic researcher would be.”

Does this mean that the 2012 article is irrelevant? Certainly not, but in light of the recent news coverage over GNC’s manufacturing irregularities, the on-going debate over regulating dietary supplements as food, and marketing abuses (particularly online) of structure/function claims, it’s not surprising that the Fourth Estate jumped all over Dr. Byers’ findings branding them as “new” to enhance media value.

But that doesn’t make it so.

Sticking to the facts is what news organizations are supposed to do – making the facts more than they are isn’t journalism – it’s hype. And that serves neither the public nor the public health.

Most dangerous outcome here is that the media hype leads people to stop taking important vitamin supplements.

Facts do not need to be … supplemented.

Per Genervon, what is the position of the patient community?

The ALS Association, appreciates the statement that the FDA released today calling on Genervon “to release all the data from the company’s recently completed trial in order to allow a more informed discussion of the trial findings among ALS stakeholders.”

Stand by for more on this on-going debate.

Oz the World Turns

  • 04.27.2015

From the pages of the Kansas City Star …

Well-meaning but erroneous online medical advice can be deadly

The most famous recent source of bad advice, according to a group of prominent physicians, is Mehmet Oz. His critics recently called on Columbia University to drop the talk show host (who is also a cardiothoracic surgeon) from its medical faculty, slamming him for showing a “disdain for science and evidence-based medicine” and manifesting an “egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain.”

If a heart attack doesn’t kill you, advice on your Facebook page could.

An old, discredited email has found new life on social media, advising people who are alone during a heart attack to breathe deeply and cough vigorously as a way to save their lives. This supposedly increases oxygen levels and helps blood circulate.

While the advice is well-intentioned, it is wrong. Dead wrong.

Repeated hard coughing could turn a mild heart attack into a fatal one, said Tracy Stevens, a cardiologist at St. Luke’s Mid American Heart Institute. So-called “cough CPR” is only preferable in a hospital under expert supervision.

Better advice: Immediately call 911 and chew a regular-sized aspirin.

The coughing message is but one example of potentially dangerous medical misinformation spread online and through social media.

The most famous recent source of such bad advice, according to a group of prominent physicians, is Mehmet Oz. His critics recently called on Columbia University to drop the talk show host (who is also a cardiothoracic surgeon) from its medical faculty, slamming him for showing a “disdain for science and evidence-based medicine” and manifesting an “egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain.”

Specifically Oz has come under fire for hyping “miracle” weight-loss products that were later discredited, warning viewers about arsenic in certain brands of apple juice, announcing that his own children wouldn’t be vaccinated, and for suggesting the Ebola virus could become airborne.

He makes those claims on his syndicated TV show, and word spreads further through social media.

Oz fired back, characterizing the attacks as an ugly “smear campaign” by “rent-a-scientists” working for big corporations.

Regardless of who is the culprit, the problem is growing. Last year the World Economic Forum asked its 1,500 members to identify the main concerns spanning the globe. At No. 10: the rapid spread of misinformation online, with special emphasis on the role played by social media.

Peter Pitts, president of the Center for Medicine in the Public Interest, and a former FDA associate commissioner, called such quickly spreading quackery “insidious and dangerous and, in many ways, life-threatening.”

“I’m excited that more people are getting information about their health online, but I’m concerned that some think everything they read (there) is true,” he said in an interview. “There’s a famous quote by Mark Twain: ‘Be careful about reading health books. You might die of a misprint.’ But that was back when medical information traveled at the speed of cattle boats. Now it travels around the world in milliseconds, with absolutely no quality control.”

People want to believe there are simple solutions to complex problems, he said.

“People like good news, and they all just know their doctor is wrong,” he said. “And since nature abhors a vacuum, there’s social media (and other platforms) with well-intentioned people with bad information.”

Experts urge people to search only at trustworthy sites.

“We tell everyone to go to MedlinePlus, which is produced by the National Library of Medicine,” said Linda Walton, president of the Medical Library Association. “The quality and correctness of the information has been reviewed by medical librarians and other experts.”

But checking responsible sites doesn’t always lead to a safe result. An Internet search for “Can coughing during a heart attack save your life when you’re alone?” returns the WebMD article “Coughing May Help During Heart Attack.”

Catherine Daniel, a WebMD spokesperson, noted that the Cough CPR article was datelined 2003 and clearly marked “WebMD News Archive.” She said the site had more up-to-date information that warned against the technique.

The problem, critics say, is that some readers may not go past the headline. And the article does not note that the advice is now discredited, and potentially deadly.

“That’s very misleading,” said Stevens, the St. Luke’s cardiologist.

These messages circulating in email and online contain more misleading and potentially harmful medical information.

 Myth: Various cancers can be cured by pureed asparagus. The message has been circulating online for years.

“There’s no human trials that any food cures cancer,” said Jeanne Drisko, professor and director of KU Integrative Medicine at the University of Kansas Medical Center, who tracks medical misinformation online.

It gets worse. Asparagus can interfere with a drug used to treat acute lymphoblastic leukemia, Drisko said, so eating asparagus actually could make some cancers worse.

 Myth: Cancer can be cured by ingesting small amounts of hydrogen peroxide mixed with water., a health and wellness website with more than 1.4 million likes on Facebook, makes this claim for “35 percent food grade” hydrogen peroxide.

“The ‘lame-stream’ mainstream media will tell you how ‘dangerous’ it is at 35 percent, but they won’t tell you that you can drip a couple drops in a glass of water each day and end cancer,” the site says. “Yes, it’s true.”

No it’s not, Drisko said.

“They are absolutely off base,” she said. “It cannot cure cancer.… And it can be very dangerous. You should never drink hydrogen peroxide. It can burn the stomach if the wrong form is consumed,” and kill in larger quantities. “That’s very bad advice.”

 Myth: Ticks can be easily removed with liquid soap and a cotton ball. This well-meaning piece of medical claptrap was supposedly shared by a school nurse:

“Apply a glob of liquid soap to a cotton ball. Cover the tick with the soap-soaked cotton ball and swab it for a few seconds (15-20). The tick will come out on its own, and be stuck to the cotton ball when you lift it away.”

Don’t do it, Drisko said. Such folk remedies — which also include painting the tick with nail polish or petroleum jelly, or using heat from a burned match head — not only don’t work, but can make matters worse by actually triggering salivary fluids from the tick, possibly leading to the transmission of disease-causing microbes.

“Your best bet is to not mess around, but to get that tick removed,” Drisko said. “Preferably in the first 24 hours.”

Experts recommend using tweezers to grasp the tick as close to its head and mouth as possible and pull slowly but firmly. If the head remains after removal, seek medical attention.

The challenge of policing medical misinformation is monumental, said Pitts of the Center for Medicine in the Public Interest. “You can’t limit a well-meaning person who wants to share their beliefs.”

That puts the onus on the health consumer. While the Internet has many reputable sites, such as the Food and Drug Administration and the Centers for Disease Control and Prevention, Pitts said, the information they provide is not always written in a way consumers can understand.

“In the U.S. our health literacy is very low,” he said. “The way to increase it is not by throwing textbooks at people. What I say is call your doctor, or talk to your pharmacist.”

Even better, he said: Get more doctors on Facebook and Twitter.

“How many physicians are on social media?” he asked. “Not many. They may be on for personal reasons, but we live in the 21st century, and that’s got to change.”


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.

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