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The closing speaker at least week’s PhRMA annual meeting (aka, the “Pharmitzvah”) was Renaissance Man Fareed Zakaria. He gave a wonderful view of the current global economic and political landscape and was in equal parts equally euphoric about the potential and brutally honest about the challenges.  Most interesting were his views on the changing nature and role of the nation state.

His was the only presentation that permitted audience participation and I was fortunate enough to ask the first question, “What is the role of the 21st century nation state when it comes to the future of healthcare?”

His answer was as dynamic as it was simple, “The x factor is innovation.”

Specifically, he believes that for a nation to be a global healthcare leader, said nation must invest its national treasure in innovation. He chose as exemplars Singapore, China, India and South Korea.  The percentage of public wealth invested by the United States doesn’t even begin to match up with that fearsome foursome.  Zakaria also pointed out that the difference between research facilities in Beijing and Cambridge isn’t quality … it’s cost.

In other words, not only are other nations investing more – they’re getting more bang for the investment yuan. All this at the same moment that President Obama disrespects pharmaceutical innovation by suggesting that we reduce the patent life of biologics from twelve years to seven.

In his closing remarks, PhRMA Chairman Chris Viehbacher summed it up nicely, “The question isn’t will our companies be successful? It’s will they continue to be successful in the United States?”

To be or not to be, that is the question. 

It certainly puts the slings and arrows into perspective.

Greetings from the 53rd annual PhRMA Annual Meeting in jaunty Jersey City. No beach. No golf. No swag.  Just a lot of content.

Some samplers from the Pharmitzvah bima:

PhRMA Chairman (and sanofi-aventis chief) Chris Viehbacher, “As I was walking up to the podium, I was asked if I needed anything.  I said, how about a President and Congress that understands the need for a research-based pharmaceutical industry.”

Quite germane and timely considering President Obama’s speech on Wednesday. (For more on that speech see here).

Viehbacher teed-up the meeting by calling on all present to embrace “the three t’s” of truth, trust and transparency.  He also mentioned that, alas, there is not (at least as of yet) “a billing code for prevention.” Amen Brother Chris.

Later on we heard a pretty dynamic speech from Governor Chris Christie who insisted that he is (and we should all be) about “results over politics.”  Amen Brother Chris.


Governor Christie was followed by our 42nd President, William Jefferson Clinton, who came on stage saying that he wanted to say something nice about the Governor, “but didn’t want to ruin his (Christie’s) reputation.” He then proceeded to give a rambling (by which I mean, charitably, eclectic) speech. Whatever he was paid it was too much -- unless he was paid by the word.

The luncheon speaker was Mike Krzyzewski (“Coach K”) who gave a very stirring and emotional talk, largely about his experience coaching the Olympic and World Championships basketball teams.  His philosophy of “standards not rules” resonated. (And his jibes about Kobe Bryant – who reneged on a promise to attend Duke after high school – were priceless.)

John Castellani, now eight months into his job as PhRMA President, captured the frustration of the crowd when, in commenting on the current political environment, quoted Oscar Wilde -- “A cynic knows the cost of everything and the value of nothing.” Nuff said. 

Amen Brother John.

Forbes Matthew Herper hones in how team Obama is tossing PhRMA and patients under the bus in an effort to preserve Obamacare. Given how government rationing and CER are used to deny patient access and shorten lives, the president's spin about 'winning the future' through medical research reaches a new post-modern level of deceit.
 

Why did President Obama declare war on healthcare innovation on Wednesday?

It’s hugely disappointing that the same man who (as a United States Senator) once said that …

Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."

… is now advocating a series of policies that would result in precisely the opposite.

That’s not class warfare – it’s no-class warfare. And it’s deleterious to the public health.

Exhibit A:  The Non-Interference Clause

The first question to ask is, what did Senators Tom Daschle and Ted Kennedy know that President Obama does not?  The answer is that allowing the Federal government to directly negotiate for Medicare drug prices is a bad idea.  That’s why they (Daschle and Kennedy) drafted the original language for the Non-Interference Clause.

Politics aside, consider the facts:

"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."

Stanford Business School's Alain Enthoven and Kyna Fong


And in the words of the American vox populi (aka, USA Today):


"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."


Many of the President’s men and women are ready with the following talking point, “Look at how successful direct Federal negotiation works for the Veteran’s Administration,” suggesting that allowing the feds to directly negotiate for Part D is no different from the current VA scenario. But suggesting that the Veteran’s Administration “negotiates” prices for prescription drugs is a false premise. 

Under rules set by Congress, to sell drugs to the VA, companies must offer each drug at a price that “represents the same discount off a drug’s list price that the manufacturer offers its most-favored nonfederal customer under comparable terms and conditions.” The medication must be offered “at a discount of at least 24 percent off [the] nonfederal average manufacturer price (NFAMP). An excess inflation rebate is also required, equal to the percentage by which the price increase for [the] drug has exceeded the consumer price index (CPI) in the prior period.” The manufacturer must make all of its drugs available through the Federal Service Schedule for any of its drugs to be eligible for reimbursement under the VA and Defense Department health systems, the Public Health Service (including the Indian Health Service), the Coast Guard, and the various state Medicaid programs.

A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA formulary’s drugs are more than eight years old and more than 40 percent are 16 years old or more. Just 19 percent of all prescription drugs approved by the FDA since 2000 are available to veterans; only 38 percent approved during the 1990s are.

There’s a big difference between negotiating and mandating – and it’s not a thin line.
My fear is that a government negotiated Part D plan is but the first step towards a more strident program of government price controls.


The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause. 

Consider:

* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.

Why?  Marketplace competition.


* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.

* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.

Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.

We shouldn’t interfere with success.

By revoking the Non-Interference clause, Uncle Sam will be able to "negotiate" prices for Part D drugs.  That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head.  There's also the potential for Uncle to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.

“Direct negotiations” means price controls.  And price controls = choice controls.


Exhibit B:  Biosimilars

The President wants to reduce the number of years of patent exclusivity for biologics. After speaking (during the State of the Union and a widely quoted op-ed in the Wall Street Journal) about the need for America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.

The President’s now seeks to hasten availability of biosimilars by cutting the market exclusivity of innovators from 12 years to seven.

Bad idea since a longer period of exclusivity funds an innovator company’s research and development efforts.
If the President’s proposal becomes law, the US would provide less data protection for innovative biologics than Europe.

12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.


What’s next – an executive order instructing the FDA to approve biosimilars without clinical trials?  Alas – this is unfortunately not a far-fetched idea considering the tone and substance of President’s speech on Wednesday. 

If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”


Exhibit C:  IPAB

And then there’s the President’s idea that Congress should lower the threshold for the Independent Payment Advisory Board (IPAB) to make Medicare cost-cutting proposals, which could include containing drug costs. As BioCentury correctly explains, “Under PPACA, the board's recommendations would automatically be adopted unless Congress enacted alternative cuts of the same size. Under the law, the board will only act if Medicare growth per beneficiary exceeded GDP per capita by at least 1%, a rate of increase that the Congressional Budget Office recently said is not likely to occur. The White House wants to lower the threshold to GDP plus 0.5%”

There’s already the very real risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the boardroom, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs. The President’s proposal makes this twice as bad.

Well – at least the President didn’t trot out drug importation. Well – at least not yet.

For the record, the solution is innovation.

We have to embrace innovative technologies for medical records and prescribing.  We need innovative clinical trial designs and molecular diagnostics so that we can develop better, more personalized medicines faster and for far less then the current $1 billion plus delivery charge.  We need innovation in access and reimbursement policies that rewards speed-to-best-treatment rather than more lower-cost patients per hour.

So we’d all better start taking innovation – of both the incremental and discontinuous varieties – seriously.  And that means both spending more on harder developmental R&D (with concomitant higher investment risks).

There’s lip service to the need for more robust comparative effectiveness – although this is a battle yet to be either defined (comparative effectiveness or cost effectiveness or clinical effectiveness?) or fought (do we need a U.S. version of NICE?).

L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning. Let’s keep our eye on the prize.  No, not the 2012 elections – the real prize: better access to healthcare for all Americans.  Innovation that focuses on creating a chronic healthcare culture that embraces prevention and prophylactic care.  Rather than wasting time on spin, let’s redouble our efforts on innovation.  Then, when we succeed through brainpower and teamwork (and, hopefully some civil bipartisanship), the circus surrounding the President’s budget proposal will be but a footnote in the history of American healthcare.

Tom Sullivan, founder of Rockpointe, Inc., has written an excellent piece on the grossly misguided policies that continue to restrict physician collaboration with industry:
 
As the number of restrictions on physicians working with industry continue to grow, and the places where policies prohibit physicians from collaborating with industry expand, close examination of the reasons supporting these policies is necessary.

The current trend of academic medical centers (AMCs), professional organizations, and States that have begun adopting policies that restrict permissible interactions and activities between industry and physicians dawned shortly after a set of recommendations proposed by Brennan and colleagues in 2006. Examples of the proposed policies placed restrictions on faculty, residents, students, and staff, which prohibited gifts, samples, and several other activities.

One of the main reasons AMCs began to adopt these policies was an attempt to avoid financial conflicts of interest that compromise core values of altruism and fiduciary relationships. In their view, profit motives and financial gains unavoidably introduce bias in medical decision-making and violate public trust. However, there is number of reasons why the adoption of such policies by AMCs is problematic.

Accordingly, a recent editorial by Don K. Nakayama, M.D., M.B.A. Chairman of Department of Surgery at Mercer University School of Medicine, In Defense of Industry-Physician Relationships in the American Surgeon, identified the misperceptions and myths that have led some AMCs and organizations to adopt such restrictive policies on industry interactions.  In his editorial, Dr. Nakayama comes to the “defense of industry-physician relationships” by examining the economic, ethical, and legal foundations for conflict of interest restrictions between physicians and pharmaceutical and medical device industries (“industry”).

From the Pink Sheet ...

FDA is making the case for increased data-sharing and disclosure about drug development failures in the name of bolstering regulatory science.

In a speech to the Food and Drug Law Institute’s annual meeting on April 5, FDA Commissioner Margaret Hamburg said agency disclosure of reasons why a drug failed to win approval would strengthen the scientific underpinnings of drug development and regulatory review.

In addition, the agency is examining how it can mine its databases of submitted applications and approved products to help address scientific uncertainties in the development process.

 Hamburg used the FDLI speech to link two of her key initiatives since joining the agency in May 2009 – strengthening regulatory science and increasing transparency of agency actions.

Despite the agency’s stance that increased data-sharing and disclosure would speed the drug development process, such concepts are sure to see pushback from pharmaceutical companies concerned about protecting proprietary information.

Spurring Innovation …

Hamburg’s speech to FDLI focused on the theme of innovation and what she said was FDA’s responsibility “to take advantage of our unique position” to help deliver new, ground-breaking medical products.

“Innovative products that are truly transformative create unique scientific and regulatory challenges, so we’re rolling up our sleeves, developing FDA’s regulatory science and innovation initiative strategy and doing everything that we can to rise to the challenges and to ensure that FDA is a consistently powerful catalyst for innovation,” Hamburg said.

“Moving forward, we’ll focus our efforts on several distinct yet inter-related areas of activity, each of which must be addressed if we are to make a meaningful difference in supporting innovation.”

The first area she touched on is regulatory reform, saying, “We’ll continue to work hard to streamline and modernize regulatory pathways and make them more predictable and transparent.” She cited several examples of FDA action in this regard, including its ongoing implementation of the “21st Century Review Process,” also known as good review management practices, and encouraging a quality-by-design approach to drug manufacturing.

“In each of these cases regulatory reform involved changing practices but also developing and applying better scientific understanding and tools to the review process, which brings me to the second area, strengthening science and reducing scientific uncertainty,” Hamburg said.

Hamburg unveiled her regulatory science platform in October. Among the initiative’s goals are modernizing product development; improving the speed, efficiency and predictability of the development, application review and manufacturing process; and using informatics to enhance health and drug safety

FDA’s fiscal 2012 budget request seeks $48.7 million in new funding for the program

Regulatory uncertainty is rooted both in scientific uncertainty and the failure to capitalize on existing knowledge, she said.

“At FDA, we have all of the data for every medical product ever submitted and approved in the U.S. There are huge opportunities to mine this information for the benefit of everybody to learn how to more effectively design drugs, to learn more about why products fail and how to better predict failure, and perhaps how to repurpose certain … drugs as we learn more about how to better assess subpopulations of responders.”

Developing new ways to share data and enhance communications with companies, without compromising trade secrets and other important commercial confidential information, is an important priority for FDA and should be for industry as well, Hamburg said. “This is part of what I mean by changing systems. We need to replace what is outmoded or not working with stronger, more effective patterns of practices.”

…Instead Of Waiting For Failure

During the question-and-answer session following her speech, Hamburg was asked how the concept of data-sharing would work “on a nuts and bolts basis” given industry concerns with such a proposal.

“This is an area that we’re obviously looking at carefully and cautiously and any decisions going forward would be done in partnership … with our key stakeholders,” she said.

She noted that agency scientists already have begun looking at data-mining opportunities with external partners, and the agency’s Transparency Initiative is examining some of the issues pertaining to disclosure.

FDA’s Transparency Task Force issued draft recommendations in May aimed at increasing public disclosure about agency actions. These included disclosing the existence and contents of “complete response” and “refuse to file” letters for NDAs and BLAs, as well as summary safety and effectiveness information for investigational applications or pending marketing applications if doing so would benefit public health

Many of the disclosure proposals drew strong objections from the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization, which raised concerns about protecting trade secrets and the recommendations’ legality

However, Hamburg pointed to the benefits of disclosing information about why a drug was not approved.

“That can contain very, very important information to the R&D field more broadly,” she said, noting that there might be “multiple sponsors developing drugs following scientific pathways that, based on earlier work done, we know will fail. It’s not in the interest of those companies or the broader public good to just sit and watch them fail.”

Hamburg suggested that industry and individual companies would have to be on board with the disclosure concept. “A given company would have to be willing to say, ‘I understand there is a common good here … even though it might be demonstrating my dirty laundry just a little bit.’”

FDA is not alone among regulators in seeking to encourage such data-sharing and disclosure on drugs in development and clinical failures, she said.

“This is something that other regulatory authorities are also thinking about and working on as well because it’s an issue of really helping to build out the underlying science as we think about how can we make both the medical product development process as targeted and as effective and as efficient as possible, and how can we utilize the information that we have as regulators to support that process.”

Hamburg was asked whether FDA is discussing unilateral disclosure of information about drug development programs even if a sponsor objects. “It’s a discussion that we’re having, and I think it’s a partnership working with industry,” she said. “We need to move in directions that make sense, that will have value added, and where everyone understands the expectations and the opportunities.”

By Sue Sutter

Blurry Vision

  • 04.12.2011

Good feature in the April edition of Nature Biotechnology.  Penned by Jeff Fox, the atrticle is titled, "Mixed Messages from Washington."

How unusual!

Good parts about FOBs and FDA funding as well as other excellent bits.

One snippet, "PDUFA negotiations provide an excellent opportunity to lay it on the line honestly and explain to Congress why FDA needs to be funded robustly.  PDUFA, "gave industry better predictability and FDA more money, but it swerved off that path and promises were not kept.  Industry now wants to get back to those promises."

Who said that?  For the answer to that question and many others, see the complete article
here.

A BILL

To protect all patients by prohibiting the use of data obtained from comparative effectiveness research to deny or delay coverage of items or services under Federal health care programs and to ensure that comparative effectiveness research accounts for advancements in personalized medicine and differences in patient treatment response.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ‘Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2011’ or the ‘PATIENTS Act of 2011’.

SEC. 2. PROHIBITION ON CERTAIN USES OF DATA OBTAINED FROM COMPARATIVE EFFECTIVENESS RESEARCH; ACCOUNTING FOR PERSONALIZED MEDICINE AND DIFFERENCES IN PATIENT TREATMENT RESPONSE.

(a) In General- Notwithstanding any other provision of law, the Secretary of Health and Human Services--

    (1) shall not use data obtained from the conduct of comparative effectiveness research, including such research that is conducted or supported using funds appropriated under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5) or authorized or appropriated under the Patient Protection and Affordable Care Act (Public Law 111-148), to deny or delay coverage of an item or service under a Federal health care program (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a-7b(f))); and

    (2) shall ensure that comparative effectiveness research conducted or supported by the Federal Government accounts for factors contributing to differences in the treatment response and treatment preferences of patients, including patient-reported outcomes, genomics and personalized medicine, the unique needs of health disparity populations, and indirect patient benefits.

(b) Rule of Construction- Nothing in this section shall be construed as affecting the authority of the Commissioner of Food and Drugs under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

sun-sentinel.com/news/opinion/fl-nbcol-avastin-brochu-0407-20110407,0,5456672.column

South Florida Sun-Sentinel.com

Put Avastin, and the FDA, back on the fast track

Nicole Brochu

Sun Sentinel Columnist

April 7, 2011

Advertisement

The FDA's announced intention to revoke Avastin's approval as treatment for late-stage breast cancer continues to inflame debate, with most commentary I've seen resoundingly against the government's plans. Here, a patient advocate provides some insight on the FDA's flawed process for fast-track approval of drugs. Give it a read and tell us your thoughts in the comment section below. — Nicole Brochu

By Robert Goldberg

At a time when the approval of new cancer drugs is declining, why is the FDA making it even harder to keep existing treatments on the market? When the FDA in December announced plans to revoke Avastin's designation as a breast cancer treatment, many Americans received their first exposure to the FDA's dysfunctional fast-track approval program. And it's clear the FDA decision and others like it are partly to blame for the fact that less than 5 percent of all cancer drugs in development make it to patients.

Since it was approved for treating advanced breast cancer in 2008, Avastin has helped improve the quality of life for many women suffering from the disease. By working with chemotherapy drug Taxol, Avastin can slow the growth of tumors — or even shrink them in certain patients.

Now the FDA has changed its mind about Avastin after a subsequent study — one required under the fast-track approval program — suggested it did not sufficiently prolong the average life expectancy of breast cancer patients. But extending average lifespan was not why Avastin was approved in the first place. Sometime between approving the drug and evaluating the follow-up study, the FDA moved the goalposts.

Such follow-up studies are both the heart and the Achilles heel of the fast-track approval program. In exchange for speedy approval of lifesaving cancer drugs, pharmaceutical companies must promise to conduct follow-up studies proving that the drugs can get the job done. Unfortunately, those studies have proven difficult to complete, with some taking more than six years, according to the FDA. Even when the studies are completed, the drug makers' only reward is sometimes the revocation of its approved status.

Why do these follow-up studies pose such a challenge for drug manufacturers? The FDA was wondering the same thing and grilled representatives from GlaxoSmithKline, Eli Lilly and Amgen about the delays at a February advisory committee meeting.

The drug companies offered a range of defenses. For drugs approved for rare forms of cancer, like GlaxoSmithKline's Bexxar, it can be tough to find enough patients to generate reliable results. Other trials can't go forward because by the time drug makers get around to doing them, the protocols have grown outdated — a point the FDA conceded.

The FDA is now making a show of how seriously it takes these studies. "These confirmatory trials are as important — if not more important — than the initial trials leading to the accelerated approval," FDA cancer chief Richard Pazdur told the assembled companies. But if the agency really wants to see them completed, it should support real-world studies to identify which patients respond best to specific drugs. And a good place to start would be to encourage the development of new medications with that focus.

As it stands now, the FDA's hurdles for cancer drugs are increasing. Avastin was approved for late-stage breast cancer more than two years ago because of its effects on tumor growth, which helped many patients live longer and more comfortably. But the new standard that the FDA used to evaluate the follow-up study last summer is called "overall median survival," which measures how long the average patient lives because of the drug.

Unfortunately, Avastin doesn't fare well under that standard because the bulk of its benefit falls on a key set of "super responders" who live significantly longer. For the average patient, however, Avastin only improves the quality of life rather than significantly extends it.

This would not be the first time a fast-tracked drug has been stripped of its designation because of a follow-up study. When AstraZeneca turned in follow-up data on lung cancer drug Iressa in 2005, the FDA pulled that approval as well, though the drug has gained new life from genetic screening. Four other drugs have met a similar fate. If the FDA allowed companies to keep drugs on the market while studying them — as they do with HIV drugs — everyone would have learned more faster.

Genentech is appealing the FDA's decision on Avastin, and concerned breast cancer patients have asked Congress to intervene. Many believe that the FDA was influenced by Avastin's high cost, even though the agency is only supposed to consider safety and efficacy. If the ruling is allowed to stand, a good drug will once again fall victim to bad policy, and countless women could miss out on months or even years of life gained from taking Avastin.

Drugs are granted fast-track approval to further study. If the FDA wants to see those studies completed quickly and competently, it needs to stop skewing the outcomes by changing the rules of research. Such behavior contributes to a decline in new cancer drugs being approved. We must reverse course. Correcting the Avastin decision is a good place to start.

Dr. Robert Goldberg is vice president of the Center for Medicine in the Public Interest. He is also author of "Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit" (Kaplan, December 2010).

Please sir, I want some more … of my medicine.

According to the Daily Telegraph:

Cash-strapped health authorities are doubling the effective cost of medicines for some patients with long-term conditions. They are urging GPs to reduce the number of pills on a given prescription, which now cost £7.40 a time in England. In some cases the number of pills per prescription has halved.

While health authorities say the guidance is to help reduce the NHS bill for wasted medicines - estimated at up to £300 million a year - there is suspicion that health authorities are increasingly resorting to the measure for financial reasons.

Health care trusts have been asked to changed their guidance to GPs in order to get them to issue shorter prescriptions for some patients.

Our friend and colleague David Taylor, professor of pharmaceutical policy at the University of London, warned that shorter prescriptions for those who were "well established" on medications could actually increase costs because of higher dispensing fees.

He said: "You need a flexible approach and not a rigid rule."

David Stout, chief executive of the PCT Network (one of the largest health care trusts), emphasized the prescription rationing idea was to save money through cutting waste, rather than increasing prescription charge revenue.

Further, study after study demonstrates that the more frequently a patient has to refill a prescription, the more likely that patient is not to refill that prescription.

Non-compliance is a bad strategy for cost-containment.

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.

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