Latest Drugwonks' Blog

Wither "the Deal?"

  • 07.17.2012

From the fine  folks at the DIA …

Supreme Court's Health Care Decision was Announced, Now What Does it Mean for the Biopharmaceutical Industry?



To cure your headache over the sometimes confusing decision and more confusing commentary about the Affordable Care Act Supreme Court decision, hear three veteran health law and policy experts explain what to expect in the wake of the decision. They will detail what the case decided, what changed and what didn’t, then explore how it may affect biopharma companies, as well as the political implications and what Capitol Hill might do next as health reform evolves.

Join us on July 26 from 11:00 AM-12:30 PM ET for the Will the PhRMA Deal Stand and What Happens Next? What the Biopharmaceutical Industry Needs to Know in the Wake of the Supreme Court Decision Upholding the Affordable Care Act webinar where you'll hear experts cut through the hype to consider the real effects of the Supreme Court's decision on the drug, device and biopharma industries.

Moderator:
 John F. Kamp, JD, PhD 
Executive Director
, Coalition for Healthcare Communication

Presenters:
 Peter J. Pitts, Former FDA Associate Commissioner 
President, Center for Medicine in the Public Interest

Arnold I. Friede, Former FDA Associate Chief Counsel, Principal, Arnold I. Friede & Associates

Richard Manning, PhD 
Partner
, Bates White Economic Consulting

Agenda and Event Details
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1-215.442.6199
Ellen.Diegel@diahome.org

Balm's Away

  • 07.16.2012

Is there no balm in Gilead?  Is there no physician there?
-- Jeremiah, viii. 22

Remember when the President said that, under his healthcare reform plan, “If you like your doctor, you can keep your doctor”? Well, that turned out to mean – “If your doctor accepts your new insurance plan, you can keep your doctor.” As my grandmother used to say, “A half truth is a whole lie.”

Now, we must grapple with an even more serious attack on the doctor/patient relationship – essential health benefits. Under the law, insurance policies sold to individuals and small businesses must cover 10 so-called “essential health benefits,” including hospitalization, maternity care and prescription drugs. (See the complete list of benefits here.) But each state will determine how insurance companies cover those benefits in that state.

Or will they?

Representatives Henry Waxman (D-Calif.), Sander Levin (D-Mich.) and George Miller (D-Calif.), ranking members, respectively, on the House Energy and Commerce, Ways and Means and Education and the Workforce Committees, sent a letter to HHS Secretary Kathleen Sebelius (PDF) about the essential health benefits bulletin. The lawmakers contend that when they wrote the Patient Protection and Affordable Care Act, the essential health benefits package was intended as a federal decision, and that one of the primary goals of the healthcare reform law was to create a consistent and comprehensive level of coverage for Americans nationwide.

So, according to these lawmakers, it’s Washington that’s going to decide what’s essential and what’s not – further disempowering a physician’s ability to practice medicine. It’s another step towards one-size-fits-all medicine – the polar opposite of personalized medicine.

This issue of essential health benefits – what they are and who calls the shots – is at the crux of the battle against government-run healthcare.

Late last week, according to BioCentury, a group of 28 Representatives sent a letter to HHS expressing concern about a CMS proposal that may allow insurers to cover only one drug per therapeutic class under the Affordable Care Act's essential health benefits (EHB) plans. The group said a requirement that insurers cover only one drug per therapeutic class would be "overly restrictive," adding that the policy ignores patients' clinical needs and would lead to poorer clinical outcomes and greater healthcare costs.

The group urged HHS to require the plans to cover "all or substantially all" drugs for six therapeutic classes: antidepressants, antipsychotics, anticonvulsants, antiretrovirals, antineoplastics and immunosuppressants. The group noted that products in these classes are not clinically interchangeable, and that the products often have a high discontinuation rate because of lack of efficacy or side effects, requiring patient access to and coverage for multiple products in the same therapeutic class. CMS implemented the same requirement for Medicare Part D in 2006.

While “what” is defined as “essential” is, of course, crucial – the issue of “who” is paramount.

Do you really want Henry Waxman telling your doctor how to practice medicine?

Here is the FDA's statement on it's monitoring of certain employee computers:

The FDA takes very seriously our responsibility to safeguard the confidential information we receive each year from the industries we regulate as well ensuring the ability of employees to voice their concerns.

Shortly after learning that confidential information had been released outside the agency, the FDA initiated monitoring of a small number of FDA employees for whom the agency had evidence suggesting that they might be responsible for the unauthorized disclosure of proprietary information.

The monitoring was limited and intended to determine whether confidential commercial information had been inappropriately released to the public. The agency's monitoring was limited to the government-owned computers of five employees and was only intended to identify the source of the unauthorized disclosures, if possible and to identify any further unauthorized disclosures. These steps were taken because FDA, in order to serve the public health of the American people and respect the proprietary interests of the manufacturers, is statutorily required to protect commercial confidential information and trade secrets. The FDA is legally prohibited from releasing this information without legal authorization.

FDA did not monitor the employees’ use of non-government-owned computers at any time. Neither members of Congress nor their staffs were the focus of monitoring. At no point in time did FDA attempt to impede or delay any communication between these individuals and Congress. Employees have appropriate routes to voice their concerns without disclosing confidential information to the public, and FDA has policies in place to ensure employees are aware of their rights and options.

The FDA's ability to protect and promote public health in the U.S. is tied to our ability to protect confidential information. This allows us to work with industry to ensure the quality of FDA-regulated products and also encourages outside stakeholders to provide us with information that would allow the agency to identify any wrongdoing. 

News from FDA:

The Office of Pharmaceutical Science (OPS) is proud to announce the selection of Gregory P. Geba, M.D., M.P.H., as Director of the Office of Generic Drugs (OGD) effective July 15, 2012.

Dr. Geba has served in senior-level clinical/managerial positions in the pharmaceutical industry for the past 15 years. He most recently served as Deputy Chief Medical Officer for Sanofi US, where he provided medical and scientific leadership and managerial direction to a staff of approximately 500 multidisciplinary scientific and regulatory professionals engaged in drug development activities across all therapeutic areas, as well as to the company’s field medical group.

He has contributed to the registration of more than 20 currently marketed drugs or devices across multiple therapeutic areas. In so doing, he successfully employed his working knowledge and demonstrated practical application of drug manufacturing processes, current quality and risk management processes, and standards relevant to FDA’s laws and regulations. He brings extensive clinical research experience, including leading or serving as the key point in filing new drug applications, biologic license applications, and promotional studies comparing efficacy and effectiveness of novel biopharmaceuticals versus standard of care (including regimens containing branded or generic drugs), and has provided or supervised key safety updates and presentations to FDA Advisory Committees. Dr. Geba’s experience also includes leading medical affairs activities while serving in a variety of senior-level positions. His scope of responsibility in those activities included contribution to the design of experimental protocols and assessment of data from pre-clinical, animal, and first-in-human studies; design, implementation, analysis, and interpretation of phase 2a proof-of-concept and 2b dose ranging studies; and production of important comparative effectiveness and safety data when assessing benefit-risk relationships during phase 3, phase 3b, and phase 4 studies.

Dr. Geba received his medical degree from the University of Navarre and his M.P.H. from the Johns Hopkins Bloomberg School of Public Health. He joins OGD at an opportune time to lead our expanding generic program into a reorganization of both structure and process to improve coordination, communication, and efficiency, as well as enhance the Office’s ability to ensure that all generic drugs—which make up nearly 80 percent of prescriptions filled in the United States—are safe, effective, of high quality, and interchangeable with the brand name drug product/reference listed drug.

The Pre-Sub Club

  • 07.13.2012

Medical technologists -- welcome to the world of "non-binding advice."

The U.S. Food and Drug Administration plans to provide medical device makers feedback before they apply for marketing approval to help companies identify regulatory requirements early in the device development process.

The new program, called "Pre-Sub," is in response to a MDUFMA that increases fees in return for more meetings.

"FDA's early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process," said Christy Foreman, director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health (CDRH).

The FDA is seeking public comment on the Pre-Sub draft guidance.

Consider how Lilly’s social media presence grows.

Riding the success of its LillyPad blog and broader social media identity, Eli Lilly & Co. is branching out from the U.S. and Canada to Europe and south of the border in Mexico.

Lilly launched its LillyPad blog (http://lillypad.lilly.com) less than two years ago as a platform to discuss healthcare innovation and policy. On Twitter, the company tweets under the LillyPad handle about similar issues and has nearly 9,000 followers. Like most social media networkers in pharma, Lilly stays away from product-oriented issues and devotes attention to broader subjects in the healthcare realm.

With LillyPad branches in Europe and Mexico, the company can play by nation-specific rules and discuss off on the issues that are relevant to individual nations. Lilly also wants to give a tailored voice to specific business units. The company's clinical open innovation team, for example, has begun blogging and tweeting.

 Lilly’s emerging social media strategy appears to include establishing a wider presence in the global social media world while building targeted audiences based on factors such as geography and subject matter.  

New York Times Articles

I BEG TO DIFFER; The Fat Epidemic: He Says It's an Illusion

By GINA KOLATA
Published: June 08, 2004

 

Ask anyone: Americans are getting fatter and fatter. Advertising campaigns say they are. So do federal officials and the scientists they rely on.

But Dr. Jeffrey Friedman, an obesity researcher at Rockefeller University, argues that contrary to popular opinion, national data do not show Americans growing uniformly fatter.

Instead, he says, the statistics demonstrate clearly that while the very fat are getting fatter, thinner people have remained pretty much the same.

Let it be said that Dr. Friedman, a Howard Hughes Medical Institute investigator and the discoverer of the gene for leptin, a hormone released by fat cells, is not fat. He is tall and gangly, with the rumpled look of an academic scientist.

As an obesity researcher, he might be expected to endorse the prevailing view that obesity in this country is out of control. But Dr. Friedman said he was outraged by the acceptance of what he sees as a hurtful myth, one that encourages people to believe that if you are fat, it is your fault.


Dr. Friedman points to careful statistical analyses of the changes in Americans' body weights from 1991 to today by Dr. Katherine Flegal of the National Center for Health Statistics. At the lower end of the weight distribution, nothing has changed, not even by a few pounds. As you move up the scale, a few additional pounds start to show up, but even at midrange, people today are just 6 or 7 pounds heavier than they were in 1991. Only with the massively obese, the very top of the distribution, is there a substantial increase in weight, about 25 to 30 pounds, Dr. Flegal reported.

As a result, the curve of body weight has been pulled slightly to the right, with more people shifting up a few pounds to cross the line that experts use to divide normal from obese. In 1991, 23 percent of Americans fell into the obese category; now 31 percent do, a more than 30 percent increase. But the average weight of the population has increased by just 7 to 10 pounds since 1991.

Dr. Friedman gave an analogy: ''Imagine the average I.Q. was 100 and that 5 percent of the population had an I.Q. of 140 or greater and were considered to be geniuses. Now let's say that education improves and the average I.Q. increases to 107 and 10 percent of the population has an I.Q. of above 140.

''You could present the data in two ways,'' he said. ''You could say that the average I.Q. is up seven points or you could say that because of improved education the number of geniuses has doubled.''

He added, ''The whole obesity debate is equivalent to drawing conclusions about national education programs by saying that the number of geniuses has doubled.''

Not everyone agrees.

''It' s one thing to talk about statistics and another to talk about what's happening to individuals,'' said Dr. Marion Nestle, a professor of nutrition, food studies and public health at New York University. ''Everyone notices that there are more overweight people now.''

Dr. Friedman, however, begs to differ. The statistics let scientists get beyond impressions and focus on the evidence.

He is, in a way, an unexpected figure to insert himself into the highly charged politics of obesity. He left clinical medicine in 1980 after discovering that his true passion was the laboratory. By 1981, he had begun his scientific career, and within a few years he was taking on what seemed like an impossibly onerous task, finding a gene whose absence made mice grow massively obese.

He keeps mementos from those days. He still has the purchase order, from December 1986, for the first batch of mice he used for the experiment. Hanging on his office wall is a framed strip of white paper with black blotches, the data that on Sunday morning, May 8, 1994, revealed he had found the gene that he named leptin.

''To me, those data are as beautiful as the Mona Lisa,'' he said.

Over the years, Dr. Friedman says, he has watched the scientific data accumulate to show that body weight, in animals and humans, is not under conscious control. Body weight, he says, is genetically determined, as tightly regulated as height. Genes control not only how much you eat but also the metabolic rate at which you burn food. When it comes to eating, free will is an illusion.

''People can exert a level of control over their weight within a 10-, perhaps a 15-pound range,'' Dr. Friedman said. But expecting an obese person to decide to simply eat less and exercise more to get below the obesity range, below the overweight range? It virtually never happens, he said. Any weight that is lost almost invariably comes right back.

The same goes for gaining weight in general, Dr. Friedman argued. A person who has the genes to be thin is not going to get fat because portion sizes increase. It makes no scientific sense, he said.

But isn't it true that we can decide to eat or not, choosing to skip dinner, say, or pass up dessert? Isn't that free will? Not really, Dr. Friedman said. The control mechanisms for body weight operate over months, even years, not day to day or meal to meal.

''People live in the moment,'' he said. ''They lose weight over the short term and say that they have exercised willpower,'' but over the long term, the body's intrinsic controls win out. And just as willpower cannot make fat people thin, a lack of it does not make thin people fat.

No one, he says, can consciously calibrate their food intake as precisely as the body does naturally. Most people's weights remain steady, within about 10 pounds, year in and year out. But when people count calories, they typically err by about 10 percent. For someone who eats 750,000 calories in a year, that 10 percent error would add up to 75,000 calories, or about 25 pounds.

Obesity, Dr. Friedman says, is a problem; fat people are derided and they have health risks like diabetes and heart disease. But it does no one any good to exaggerate the extent of obesity or to blame the obese for being fat.

''Before calling it an epidemic, people really need to understand what the numbers do and don't say,'' he said.

 

Fizz Ed

  • 07.11.2012

Obesity is largely a question of calories in and calories out.

So why is Mayor Bloomberg only concerned about the “calories in” part?

Is the Mayor’s focus on Big Gulp Disease a sleight of hand to divert attention from the city’s inability (or is it unwillingness) to address the “calories out” part of the equation?

In its biennial survey of high school students across the nation, the CDC reported in June that nearly half said they had no physical education classes in an average week. In New York City, that number was 20.5 percent, compared with 14.4 percent a decade earlier.

That echoed findings by New York City’s comptroller, in October, of inadequate physical education at each of the elementary schools that auditors visited.

New York City has not filed a physical education plan with the state since 1982, though state officials recommend a new one every seven years. A spokeswoman for the city schools says one will be presented in September.

It’s time for Mayor Bloomberg to step down from the bully pulpit long enough to get our kids back into the gym.

Morning Joe

  • 07.10.2012

Kudos to the behind-the-scenes work of the FDA and the industry’s Opioids Working Group (OWG).

The FDA has approved a final class-wide REMS for extended-release and long-acting opioids that requires companies to make educational programs available to prescribers at no or nominal cost. The REMS does not require prescribers to participate in the training programs, though FDA said it is working with Congress to explore legislation to mandate prescriber training, including a prescriber education requirement as a condition of obtaining registration with the Drug Enforcement Agency.

The required educational programs must cover the content of an FDA-developed blueprint, which includes the dangers of misuse and abuse, directions for patient selection and how to recognize evidence of misuse and abuse. FDA expects the first educational program will be offered by March 2013. Companies will be required to track the number of prescribers completing the program and whether the program is adversely affecting patient access to medications.

In other news, the President signed PDUFA. The law reauthorizes both PDUFA and MDUFA and creates new user fee programs for biosimilars and generics along with a slew of other important codicils.

Strange that the White House is silent on this important piece of bi-partisan legislation. As Veep Biden once said, "It's a big, f--king deal."


Did you know that a recent study found " that most children and youth who consume soft drinks and other sweetened beverages, such as fruit punch and lemonade, are not at any higher risk for obesity than their peers who drink healthy beverages."

Or that a long term study tracking low income children (The Bogalusa Heart Study) that started in 1973 found a "positive association between diet beverage consumption and overweight resulted from the consumption of diet beverages and non-sweetened beverages. "   

Probably not.   Like me, you were too busy fixating on the proposed ban on soft drink servings over 16 oz in NYC.  

The Bogalusa Heart Study team also concluded  "eating patterns were associated with overweight in young adults. However, the eating patterns explained only 1–2% of the variance in BMI. Thus, 97% of the variance is unexplained. More studies are needed to better understand how eating patterns in combination are associated with overweight before policy changes are made. Targeting single eating patterns in obesity intervention programs may not be the best approach. This is possibly reflected in the modest-to no-effect being observed with this approachIn this study, eating patterns were associated with overweight in young adults. "

So why are lobbying organizations and interest groups and the CDC and NYC attacking soft drinks if it is -- at best -- only a sliver of that 1-2 percent explaining BMI variance?   

In part it's because attacking the eating habits of the poor -- especially the rural and minority poor -- is fair game.   But the more important reason is the belief that obesity is the underlying cause of every chronic disease and the cost of health care.   So under the guise of controlling health care costs it is now becoming legitimate to have governments tell people what to eat and drink.    You would  never know that around the world, people are living longer and healthier lives, a trend that has boosted income and prosperity over the last half century.   

Worse, a campaign is under way to claim that sugar -- or drinking soda -- is as deadly to humans as tobacco is.    That's not science.  That's the sort of fear mongering that has made people afraid of vaccinating their kids.   
CMPI

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.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog