Obamacare Application: At last, something shorter than the legislation

03/14/2013 12:41 AM |

After 1500 pages of legislation and 20 times the amount of regs, the obamacare application required to wait for a subsidy, is at 21 pages, is a work of brevity. And at least it's more coherent than Dennis Rodman. http://global.nationalreview.com/pdf/pdf_cms_2_031313.pdf   Read More & Comment...

Bloomie's Last Straw

03/12/2013 02:52 PM |

Mayor Bloomberg 's controversial ban on large, sugary sodas fell flat Monday when a judge shredded nearly every legal argument advanced by the mayor’s lawyers and tossed the regulation out.

 “Arbitrary and capricious” to be sure and, plainly speaking, trivial.

It’s important to put the situation, vis-à-vis sugar-sweetened beverages, into perspective.

Prohibition doesn’t work. How many times do we have to learn this lesson?  What works is personal responsibility and adherence to the Aristotelian Mean  (aka – moderation).

Sugar-sweetened beverages play a small and declining portion of the American diet – just 7 percent of total calories.  By nearly every measure, the contribution of calories from beverages to the diet is declining.  According to the CDC, added sugars consumed from soda is down 39 percent since 2000 and from 1999-2010, full-calorie soda sales have declined 12.5 percent.  Yet obesity rates are still rising.  We need to focus on real ideas that address the big picture.

It’s time to put tabloid headlines behind us and move on to addressing the real story.

In June the CDC reported that 20.5 percent of New York City high school students had no physical education classes -- compared with 14.4 percent a decade earlier.

New York City has not filed a physical education plan with the state since 1982. It’s time for Mayor Bloomberg to step down from the bully pulpit long enough to get our kids back into the gym.

It’s time for the Mayor to take a big gulp, stop talking about fizz and start focusing on phys ed.

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AMARC Angst

03/11/2013 08:19 AM |

Much brouhaha over the FDA’s Warning Letter to AMARC Enterprises.

The attention is due, in part, to pharma’s thirst for FDA guidance on the use of social media. Alas, while this particular FDA letter isn’t entirely ersatz, it isn’t entirely relevant to moving the agenda forward either. (Note: When asked about this letter, OPDP chief Tom Abrams passed the query along to CFSAN -- as dietary supplements are regulted as foods.) Nevertheless, there are some important lessons.

Here’s how the FDA letter begins:

This letter concerns your firm’s marketing of the products, Poly-MVA and Poly-MVA for Pets. The U.S. Food and Drug Administration (FDA) reviewed your websites, www.polymva.com and www.polymva.net, as well as literature included in the information packet which accompanied the sale and shipment of your product, “Poly MVA” on November 15 and has determined that “Poly MVA” is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The claims in the literature and on your websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act. 

Translation:  You are promoting a dietary supplement as a drug.

No news there. The letter continues:

In addition, we reviewed your websites at www.polymva4pets.com and www.polymvaforpets.com where you promote and sell your “Poly-MVA for Pets” veterinary product. We have determined that Poly-MVA for Pets is intended for use in the cure, mitigation, treatment, or prevention of disease in animals, or to affect the structure or function of the body of animals, which makes it a drug under section 201(g)(1) of the Act. [21 U.S.C. § 321(g)(1)]. Further, as discussed below, this product is an unapproved new animal drug as defined by the Act and your marketing of it therefore violates the law.  

Translation:  You are marketing a dietary supplement as an animal drug.

Okay – so this is your garden-variety structure/function violation. But here’s where it get’s interesting.

The FDA isn’t just dinging AMARC on a blasé structure/function claim. The agency is calling them out because those claims are about curing cancer!

The point to be taken here is that the agency cannot (obviously) go after every dietary supplement company making inappropriate structure/function claims. The FDA needs to prioritize, to deliver the biggest bang for the regulatory buck. And false cancer claims are right up there at the top of the list.

It’s also important to note that, of the many promotional infractions, the issue of social media is at the bottom (literally) of the letter.  This is not a letter about social media infractions, it’s a letter about promotional infractions of which social media is one dimension.

But what the FDA does write about social media is instructive:

We also note claims made on your Facebook account accessible at: https://www.facebook.com/poly.mva, which includes a link to your website at www.polymva.com. The following are examples of the claims:

            In a March 10, 2011 post which was “liked” by “Poly Mva”:

•  “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation…Thank you AMARC”

In a May 5, 2010 post you provide a link to the blog post titled, “Children with Cancer Often Use Alternative Approaches” which can be found on your website at www.polymva.com/blog-news/218/children-with-cancer-often-use-alternative-approaches. At the end of the post is the following statement and a link to the website, www.facr.org:

• “For information on how palladium lipoic complexes can nutritionally support the body during cancer and cancer therapy, visit the Foundation for Advancement in Cancer Research’s website.”

Folks – it’s not the platform that is non-compliant, it is the content. Why does everyone get weak-in-the-knees whenever the FDA mentions a contextual violation on social media? When the agency sends out warning letters on sales materials, do we jump up and down and say, “Jumpin' Jehosaphat, we can’t create sales materials!” (Or TV commercials. Or convention booth displays.)

Or websites.

Here’s what the FDA said about the AMARC website:

Examples of claims in the form of testimonials, on your websites, www.polymva.com and www.polymva.net, on the webpage titled, “Customer Experiences” include:

• “I want everyone to know that I am now 3 years clear of lung cancer!! When I was told I had a mass in my lung, the first thing I did when I returned home was to call AMARC Enterprises – the PolyMVA people. PolyMVA helped save my life. I began a regimen of PolyMVA…After 3 months, the Stage 2 cancer was down to Stage 1. And here I am, 3 years later…the PET Scan is as clear as a bell. Thank you again and again for the support that PolyMVA gave my body in my fight against cancer!”

• “...I said “No” Chemotherapy!...I became quite ill and was diagnosed with stage 3 ovarian cancer…I had surgery to remove a very large tumor and was scheduled to begin an aggressive chemotherapy regimen as the cancer had spread. Even with chemotherapy I was aware that the prognosis was not encouraging…One of the supplements that my naturopath highly recommended was Poly MVA…In my opinion anyone in my situation involving cancer could be greatly improved by using Poly MVA…”

It’s useful to look back at the FDA’s “most recent” missive on social media, the December 27, 2011 Draft Guidance, “Responding to Unsolicited Requests

For Off‐Label Information About Prescription Drugs and Medical Devices.”

Statements that promote a drug or medical device for uses other than those approved or cleared by FDA may be used as evidence of a new intended use.

Translation:  It’s the content, not the platform.

Unsolicited requests are those initiated by persons or entities that are completely

independent of the relevant firm. (This may include many health care professionals, health care organizations, members of the academic community, and formulary committees, as well as consumers such as patients and caregivers). Requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests.

Translation:  “Liking” an off-label post or sharing it under the guise of a “customer testimonial” (whether solicited or not) is off-label promotion.

The value of the AMARC letter isn’t to divine FDA intent across social media. The value is to remember that violative is violative across platforms.

In other words, if you wouldn’t say it off-line, don’t say it online.

Take a breath.

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Tick Tock. Sue the Doc.

03/08/2013 08:43 AM |

During a Nevada Senate Judiciary Committee meeting on Wednesday, numerous physicians, alleging the prescription drug abuse measure (SB 75) would lead to a healthcare crisis, especially among the elderly, in the state, were joined in their opposition by drug manufacturers and industry groups, including the Chamber of Commerce. Even his Democratic colleagues found little in the measure to support during the first hearing on the proposed bill, which Committee Chair Tick Segerblom (D-Las Vegas) developed to make it easier for consumers to file suit against drug manufacturers and healthcare providers if patients becomes addicted to painkillers that were prescribed for them.

Who is Tick Segerblom?  A lawyer.  A lawyer who works on a contingency basis.

Just sayin’.

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Nevada Craps Out

03/07/2013 06:36 AM |

Nevada Senate Bill 75, if passed as written, it would make the manufacturer of a controlled substance criminally liability if a patient develops an addiction upon using that controlled substance. Prescribers are also on the line.

This bill provides that a person who suffers injuries as a result of an addiction to a prescription drug may bring a civil action against: (1) the manufacturer of the prescription drug; and (2) the provider of medical care who prescribed the prescription drug, if the provider of medical care knew or should have known of the person’s addiction to the prescription drug.

Patients would be able to recover both actual and punitive damages, without any limitation. The bill also has a provision that states that this liability is, “notwithstanding any other provision of law”. This means that, even if there were laws that would otherwise thwart the patient’s case, they won’t apply.  The criminal laws that say one cannot illegally obtain and take prescription drugs - irrelevant.  A law that bans a patient from “doctor shopping” – doesn’t matter.  The fact that a manufacturer followed the law and disclosed all addictive information regarding a drug – immaterial.

The text of SB-75 bill can be found here.

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Interchangability -- It's more than just biosimilars

03/06/2013 08:16 AM |

In case you think the issue of interchangability is only relevant to the biosimilars debate, have a look at this story from the New York Times.

The tort bar is watching -- and salivating.

And patient care is suffering.  Read More & Comment...

Will Risk/Benefit Assessment Bite the Sequestration Dust?

03/06/2013 07:55 AM |

FDA plans to implement during FY14-FY15 a new structured benefit-risk assessment framework to review new molecular entity (NME) NDAs and original BLAs, according to a five-year draft plan released by the agency. The new framework was one of FDA's commitments under PDUFA V. FDA said it plans to implement the framework when reviewing efficacy supplements for new/expanded indications by FY16, and for all NDAs by FY17. FDA said it will publish completed frameworks for newly approved products on its website.

PDUFA V is part of the FDA Safety and Innovation Act, which was enacted in June 2012 and took effect with the start of the fiscal year in October. The law's new set of rules on the review of applications to market NMEs provide for a longer, more interactive review process between FDA and sponsors.

The draft plan is worthwhile reading – but will it gather dust during sequestration?

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Amylin's chagrin, spin, and original sin

03/05/2013 06:45 AM |

“The fact that FDA did not require you to conduct a tQT for exenatide to support the safety of Bydureon did not relieve you of your obligation to submit those data once they became available.”

So wrote FDA’s John Jenkins (Director, CDER’s Office of New Drugs) in May of 2011.

FDA documents detailing its review of the diabetes drug Bydureon exenatide indicate the agency delayed approval by a year and a half after concluding the drug’s sponsor, Amylin Pharmaceuticals Inc., had intentionally and deceptively withheld data from a QT study that agency officials believed raised serious concerns about the product’s safety.

In fairness to Amylin, they have a different perspective on the situation. (A solid review of the story is in BioCentury and is worth a read.)

Many issues arise from this situation. One is clearly related to the current imbroglio over the call from Ben Goldacre, et al. for complete clinical trial transparency. A key take-away from the Amylin story is – you can run but you can’t hide. Or, perhaps more precisely, you can’t hide for long.

More importantly, the Amylin situation points out yet another reason why the FDA needs more funding – vigilance counts.

And costs.

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Non-Interference Incoherence

03/04/2013 07:21 AM |

Congressman John Conyers just introduced a bill that, if passed, would create government-run health care here in the United States. This same proposal for a "single-payer" system has been put forth in every Congress since 2003, and like all of those previous bills, Conyers’ legislation is destined to die an unceremonious death.

Almost simultaneously, Senator Richard Durbin (D-Ill.) and Rep. Jan Schakowsky (D-Ill.) introduced into the U.S. Senate and House of Representatives versions of a bill that would require the HHS secretary to negotiate Medicare Part D drug prices with pharmaceutical manufacturers. The Medicare Prescription Drug Savings and Choice Act of 2013 would offer one or more Medicare-administered prescription drug plans to compete with the privately administered prescription drug plans currently offered under Medicare Part D. Durbin and Schakowsky have introduced versions of the bill in Congress at least three times since Part D came into effect in 2006.

But just because such brazen attempts at socialized medicine are doomed to fail doesn’t mean the threat of government-run healthcare isn’t real. In fact, the current push to allow federal price controls in the Medicare drug benefit, Part D, is a first step towards a single-payer system.

While Medicare as a whole is a fiscal basket case -- due to run out of money in 2024 -- Part D has been the very model of a well functioning federal program since its implementation in 2006.

The Congressional Budget Office (CBO) found that, between 2004 and 2013, Part D will cost an extraordinary 45 percent below what was initially estimated. Premiums for the program, meanwhile, are roughly half of the government’s original projections. Part D enrollees pay, on average, $30 a month -- a rate that has remained essentially unchanged for years.

It’s no wonder that beneficiaries are so pleased with the program. In fact, 96 percent of those enrolled in Part D say that their coverage works well.

These unprecedented results are largely due to Part D’s market-based structure. Beneficiaries are free to choose from a slate of private drug coverage plans, forcing insurers to compete to offer the best options to American seniors. It’s hardly surprising that the program has led to low prices and satisfied customers.

Of course, anywhere there are market principles at work creating value for consumers, there are liberals eager to meddle -- and Part D is no exception. First, President Obama promised to dismantle Part D in the State of the Union with his proposal to “reduce taxpayer subsidies to prescription drug companies.” This was his coded way of saying that he intends to ruin one of the best market-based government programs in history.

And now, Minnesota Senator Amy Klobuchar has introduced a bill that makes good on the president’s promise. The legislation would allow the Department of Health and Human Services to negotiate directly with drug companies in order to set prices under Part D. The bill would repeal Part D's “non-interference clause” that was included in the law specifically to stop HHS from distorting the market by strong-arming drug companies.

It’s hard to see Klobuchar’s bill as anything but a federal power grab. Unhappy that a single-payer system is a political loser, the president and his fellow liberals are content to takeover the health sector one reform at a time. After all, despite the Democrats’ false promises of cost-savings, there’s no reason to revoke the non-interference clause.

Through their own negotiations with drugmakers, private insurance plans that operate under Part D have already had great success in keeping pharmaceutical prices down. In fact, the CBO has observed that Part D plans have “secured rebates somewhat larger than the average rebates observed in commercial health plans.”

What’s more, the CBO has said time and again that doing away with the non-interference clause “would have a negligible effect on federal spending.” In a report from 2009, they reiterated this view, explaining that such a reform would “have little, if any, effect on [drug] prices.”

In fact, allowing the feds to negotiate drug prices under Part D would likely have a negative effect on the program. The CBO predicts that, when HHS forces pharmaceutical firms to lower the cost of a particular drug, this tactic brings with it “the threat of not allowing that drug to be prescribed.”

In other words, Democrats want to take a program that provides affordable medicine for millions of seniors, and reform it in a way that limits drug access without saving money or addressing any of the systemic problems that afflict Medicare.

As Mr. Conyers’ bill demonstrates, Democrats will never succeed in creating a single-payer system by passing one, all-encompassing bill. Instead, liberals in Washington will have to take over the health sector bit by bit. The push to impose Part D price controls is the latest attempt to grab a little more power for the federal government. Those who support a healthcare system that benefits from choice and competition have a lot to be concerned about.

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Oh Canada

02/27/2013 04:45 AM |

From the L.A. Times:

You’re more likely to get a doctor’s appointment in Canada if you’re rich than if you’re poor, even though the government pays the bills, according to a new study.

In the spring and summer of 2011, a team of Canadian researchers posing as prospective patients cold-called 375 doctors offices in Ontario to schedule a check-up.

The researchers posed in each call as one of four types: a wealthy banker in good health, a wealthy banker with diabetes and back problems, a welfare recipient in good health, or a welfare recipient with diabetes and back problems.

Overall, the callers were 50% more likely to be offered an appointment when they posed as bankers than when they posed as welfare recipients.
Canada has universal healthcare, and the researchers said they studied Ontario in particular because it has a single public insurer, and patient pay no copayments or deductibles for visiting a physician. In theory, therefore, general physicians in Ontario and their staffs would have no financial incentive to choose a rich patient over a poor one, according to the study, conducted by doctors at the Keenan Research Centre at the Li Ka Shing Knowledge Institute at St. Michael’s Hospital in Toronto.

Read the full piece here.



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Breaking Bad or Doing Right? NJ Signs Up For Medicaid Expansion

02/26/2013 06:36 PM |

To Chris Christie's critics (including those at CPAC that told him to stay home), his decision to accept Medicaid dollars to cover people up to 133 percent of the poverty level under Obamacare is another heretical or hypocritical act.

But I think in general states are going to have to accept the federal dollars to expand Medicaid.  It is the law of the land for better or worse and to say no to tax dollars that already being collected and not use them is a waste at any level.   

Is this how entitlements are created?  You bet.  Will Medicaid be faced with cost overruns and shortages of care and other bad stuff?  No doubt.  I could write the articles now and just add the numbers in later.   It will be up to those of us who would rather see a more rational market for medicine to change how dollars are spent.   To tell governors NOT to use Medicaid money to expand healthcare is like telling students not to get student loans for college.  Few of us have the income to match the courage of that conviction.   And any politician who does not take money to cover a new benefit is probably a politician that will not be re-elected.   People forget that Reagan expanded Medicaid coverage in California.   

From here on in -- or until there is one party Republican government -- Obamacare will be the law of the land.  The binary decision has been made.  The issues are no longer a matter of yes or no as much as they are "how much?" and "how?"

That's governing.  As James Madison wrote in the Federalist Papers: "in framing a government which is to be administered by men over men, the great difficulty lies in this: you must first enable the government to control the governed; and in the next place oblige it to control itself."

Somethings never change.  

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Obamacare's Silver Lining Playbook for Medicaid

02/26/2013 09:08 AM |

The rationale for shoving 18 million people into Medicaid was to give the appearance of a generous health plan at a price that kept Obamacare under the $1 trillion "cap."   At the time the administration told liberal advocacy groups that it would hold states accountable to preserving existing coverage even as it added more peope to Medicaid.   And the administration also refused to give states flexibility in using Medicaid dollars as Mitch Daniels did in Indiana to prevent a run on coverage and exodus of doctors.   Now that the Supreme Court ruled states can opt out of the Medicaid expansion, the administration has sent out a flare telling states it can cut payments to doctors and hospitals to save money.   Will that reduce access and increase waiting times?  Of course.  But Obamacare has always been about making more Americans depending upon government for their health care and nothing else.  The attitude is: let's get everyone 'covered' and we will ratchet down costs through price controls..  

This quote from an unnamed administrtation source  in the New York Times says it all:  “There is no general mandate under Medicaid to reimburse providers for all or substantially all of their costs,” the administration said.    Substantially.  As in ten cents on the dollar.  Maybe.   Anyone out there willing to increase their business by charging 75-90 percent less?  

States Can Cut Back on Medicaid Payments, Administration Says
By ROBERT PEAR
Published: February 25, 2013


WASHINGTON — The Obama administration said Monday that states could cut Medicaid payments to many doctors and other health care providers to hold down costs in the program, which insures 60 million low-income people and will soon cover many more under the new health care law.
Enlarge This Image

Manuel Balce Ceneta/Associated Press
Gov. Jerry Brown of California, center, on Monday during a National Governors Association meeting in Washington.
The administration’s position, set forth in a federal appeals court in California, has broad national implications as it comes as the White House is trying to persuade states to expand Medicaid as part of the new law.

The statement of federal policy infuriated health care providers and advocates for low-income people. But it may encourage wavering Republican governors to go along with the expansion because it gives them a tool to help control costs.

Byron J. Gross, a lawyer at the National Health Law Program, an advocacy group for low-income people, said: “The federal government is trying to bend over backward to show flexibility and accommodate states as much as it can. California is an example of that.”

In a brief filed with the United States Court of Appeals for the Ninth Circuit, in San Francisco, federal officials defended a decision by California to cut Medicaid payments to many providers by 10 percent.

Kathleen Sebelius, the secretary of health and human services, approved the cuts in October 2011 after finding that beneficiaries would still have “adequate access” to the wide range of services covered by Medicaid.

The Obama administration urged judges to uphold those cuts, which are being challenged by patients, doctors, dentists, hospitals, pharmacists and other health care providers in California.

AARP, the lobby for older Americans, joined the health law advocacy group and more than a dozen consumer groups in opposing the cuts, which they said would reduce access to care for millions of current and future beneficiaries.

In an interview, Gov. Jerry Brown of California, a Democrat, said the Medicaid cuts were essential to his efforts to dig the state out of a budget hole.

“California has a great record of providing more benefits, expanding to more people, doing more of everything,” said Mr. Brown, who was here for the winter meeting of the National Governors Association. “But I believe in balancing our budget, living within our means.”

“We like the president’s commitment to extend health care to as many Americans as possible, and we can be powerful partners,” Mr. Brown said. “But we need more authority than we now have. I want to emphasize that — more authority than we have now to manage the Affordable Care Act and the expansion of Medicaid.”

Medicaid is one of the fastest-growing items in state budgets. Cutting payment rates saves money for states and for the federal government, which will pay most of the costs for people who become eligible for Medicaid under the new law.

Health care providers said California’s payment rates were inadequate even before the cuts. They pointed to a federal study that said, “California stands out because of its very low Medicaid payment levels.”

In an interview, Dr. Paul R. Phinney, president of the California Medical Association, a plaintiff in one of the court cases, said: “Two-thirds of doctors in California cannot afford to participate in Medicaid because the rates are so low. The problem will only get worse if rates are cut as we move more and more people into Medicaid.”

The cuts were supposed to take effect in 2011 but have been held up, pending the outcome of litigation.

Health care providers said California was cutting Medicaid payment rates for “purely budgetary reasons.”

In court papers, the Obama administration said, “It is entirely appropriate for a state to review its Medicaid plan to determine whether it can continue to satisfy its statutory obligations at lower payment rates.” Indeed, the administration said, states should conduct such reviews “to avoid the perpetuation of payment rates that are unnecessarily high.”

Federal law says Medicaid rates must be “sufficient to enlist enough providers” so that Medicaid beneficiaries have access to care at least to the same extent as the general population in the same geographic area.

The Obama administration said California officials had agreed to monitor beneficiaries’ access to care and to “take prompt action if any problems are indicated.”

Moreover, the administration said, Congress gave states “wide discretion” to set Medicaid rates, and courts should not second-guess decisions by Secretary Sebelius on the adequacy of rates.

“There is no general mandate under Medicaid to reimburse providers for all or substantially all of their costs,” the administration said.  Read More & Comment...

Anti-Infective Invective

02/25/2013 07:03 AM |

Is the concept of “limited use” approvals falling victim to concerns that the could become a tool for the agency to narrow approved indications and to bar off-label prescribing.”

Janet Woodcock calls it like she sees it, “Given that there is skepticism and controversy, to pick an area where there is a compelling need might be a reasonable thing to do.”

It seems likely that limited use will be limited (at least initially) to anti-infective drugs.

As BioCentury points out, “Restricting the pathway to anti-infectives would allow FDA to address a public health crisis and test drive the concept, but would disappoint patient advocacy organizations and emerging biotech companies that hope the regulatory tool could speed development and approval of new drugs for a variety of conditions.”

And the pathway would be voluntary. Woodcock, “The pathway would be voluntary,” said Woodcock, and would be used to help companies tailor highly streamlined development programs to meet urgent public health needs.

The basic concept is for FDA to allow extremely streamlined development programs for drugs for well-defined subpopulations for which benefits clearly outweigh risks, and to couple expedited approvals with measures intended to discourage inappropriate off-label prescribing.

What measures? And through what authority? BioCentury opines that, “The lack of specifics and distrust of the agency’s intentions have led some critics to assume FDA is seeking a broad expansion of its power over the practice of medicine, and others to accuse the agency of plotting to allow dangerous under-tested drugs on the market.”

There is little controversy about approving drugs based on relatively small studies that demonstrate high levels of efficacy in tightly targeted populations. But FDA’s suggestion that it could work with physicians and payers to limit use of a marketed drug in the absence of documented safety concerns is controversial.

Since the FDA is being attacked from almost every side -- it’s likely they are doing something right.

And anti-infectives are a good place to start.

  Read More & Comment...

Thank you sir, may I have another.

02/22/2013 08:52 AM |

The Washington Post reports that David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, "said he will support legislation requiring pharmacies that operate like drug manufacturers to register with the Food and Drug Administration and be subject to stricter standards enforced by the agency." The Post notes, "Miller and his 2,700-member group have traditionally argued that all pharmacies should fall under the purview of state pharmacy boards, not the FDA, and fought efforts in 2007 to shift primary oversight from the states to the federal government. On Thursday, Miller said he now wants to see FDA registration for what he describes as compounding manufacturers and supports giving the agency the power to enforce safety standards for these firms."

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"Essential" -- for the time being

02/21/2013 01:43 PM |

HHS issued a final rule on Wednesday that includes language that will increase the number of drugs eligible for reimbursement by insurers under the Affordable Care Act's essential health benefits requirements. Under the final rule, insurers must cover at least one drug per therapeutic area or the same number of drugs in each category and class as specified in the state benchmark plan, whichever is greater. The rule also states that a health plan "must have procedures in place that allow an enrollee to request and gain access to clinically appropriate drugs not covered by the health plan." The language on coverage requirements for drugs is virtually identical to that included in the proposed rule in November.

In response to comments expressing concerns about the cost of the requirement, HHS said it believes the policy "reflects drug coverage in a typical employer plan and will have a negligible effect on premiums." The agency added that the policy will be a "transition" for the first two plan or policy years starting in 2014 -- when ACA is slated to come into effect -- and that it "will study and take into considerations the effects this policy, if any, have on changing typical drug coverage in the market."

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Digital Health Reform

02/20/2013 06:31 AM |

If we want to change our national healthcare paradigm we must also change the way people learn, discuss and address healthcare issues. And that means social media.

Attention Pharmaceutical Industry: If you’re not at the table, you’re on the menu.

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Measuring REMS

02/19/2013 08:48 AM |

If you can't measure it, then it doesn't count.

The FDA plans to draft guidances on how companies should create goals for a REMS and on the other metrics needed to determine if those goals are successfully met and a guidance on methodologies for assessing REMS. (FDA agreed in the PDUFA V commitment letter to issue a draft assessment guidance by the end of September 2014.)

An OIG review of 49 REMS, and the FDA’s reviews of those assessments states the obvious, “If FDA does not have comprehensive data to monitor the performance of REMS, it cannot ensure that the public is provided maximum protection from a drug’s known or potential risks.”

But sometimes the obvious is important to state.

According to the Pink Sheet, “FDA currently possesses no way to force sponsors to provide the needed assessment data, so OIG recommends the agency seek enforcement authority from Congress. FDA agreed that this recommendation should be pursued if an opportunity arises. That opportunity could be the reauthorization of the Animal Drug User Fee Act, which is eyed as a means to gain approval of a track and trace system.”

We’ll see if that dog hunts.

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Social Media: Advise and Dissent

02/18/2013 09:20 AM |

When it comes to social media, the FDA wants companies to do what’s in the best interest of the physician and the patient (really!). But there’s an unfortunate disconnect – the regulatory go-forward proposition of many companies is to avoid any regulatory ambiguity. The result is a vast regulated healthcare speech  wasteland. Alas, when it comes to social media, “in compliance” and “in the best interest of the public health” are often viewed as mutually exclusive.

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PCORI and Epigenetics: Looking Backward and Looking Forward

02/15/2013 12:42 PM |

PCORI is being propped up by syncophants in the so-called stakeholder community.  Those who claim they are advocates for patient-centered medicine should spend less time publishing and promoting the "right way" to use CER.  Instead, they should be constantly educating and reminding people of how medical progress will make CER endlessly outdated.  As the example below demonstrates,  personal epigenetics will make real-time monitoring and treatment of prostate cancer widespread.  So why are we spending millions on 'empowering' patients to decide on watchful waiting vs active surveillance or three different types of treatment?   

Personal epigenetic 'signatures' found consistent in prostate cancer patients' metastases

Discovery may help distinguish indolent from lethal cancers

In a genome-wide analysis of 13 metastatic prostate cancers, scientists at the Johns Hopkins Kimmel Cancer Center found consistent epigenetic "signatures" across all metastatic tumors in each patient. The discovery of the stable, epigenetic "marks" that sit on the nuclear DNA of cancer cells and alter gene expression, defies a prevailing belief that the marks vary so much within each individual's widespread cancers that they have little or no value as targets for therapy or as biomarkers for treatment response and predicting disease severity.

A report of the discovery, published in the Jan. 23 issue of Science Translational Medicine, describes a genomic analysis of 13 men who died of metastatic prostate cancer and whose tissue samples were collected after a rapid autopsy.

Samples from three to six metastatic sites in each of the patients and one to three samples of their normal tissue were analyzed to determine the amount of molecular marks made up of methyl groups that attach to sites along the genome in a process known as DNA methylation. The process is part of an expanding target of scientific study called epigenetics, known to help drive cell processes by regulating when and how genes are activated. Mistakes in epigenetic processes also are known to trigger or fuel cancers.

"Knowing both the genetic and epigenetic changes that happen in lethal prostate cancers can eventually help us identify the most aggressive cancers earlier and develop new therapies that target those changes," says Srinivasan Yegnasubramanian, M.D., Ph.D., assistant professor of oncology at The Johns Hopkins University School of Medicine. "But there has been an open question of whether epigenetic changes are consistently maintained across all metastatic sites of an individual's cancer."

The research team found that while methylation patterns vary from one patient to another, many methylation patterns occur "very consistently" within different metastatic sites in an individual patient. They identified more than 1,000 regions of the genome where various types of DNA methylation were consistently maintained within their 13 subjects' genomes.

"As they evolve and grow, cancer cells acquire and maintain changes that enable them to continue thriving," says Yegnasubramanian. "We know that cancer cells maintain and pass along genetic changes in the nucleus of cells across metastatic sites, and our research now shows that epigenetic changes also are maintained to nearly the same degree."

The scientists say that the consistent methylation changes they found appear to represent so-called driver changes critical to the cancer's development and could be targets for treatment. By contrast, other methylation changes found only sporadically in the metastatic sites are more likely what are called passenger changes that occur by chance and are less promising as treatment targets or biomarkers than driver changes.

"Our study shows that for prostate cancer, at least, each person develops his own path to cancer and metastasis, and we can find a signature of that path in the epigenetic marks within their tumors," says Yegnasubramanian, who envisions that certain epigenetic changes can be grouped into clusters to be used as biomarkers signaling a lethal cancer.

Yegnasubramanian and his team also plan to study how each of the driver changes work and how they influence cancer metastasis.
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Honey I Shrunk The Medicare Drug Benefit

02/15/2013 12:34 PM |

Every once in a while there's a great piece summarizing how real progress in health care is achieved.  Here's one by Jim Capretta

http://www.economics21.org/commentary/incredible-lowering-medicare-drug-benefit-baseline
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