Back genome again in Indiana

05/31/2013 06:59 AM |

Yesterday, Indiana Governor Mike Pence joined Indiana-based global life sciences and research university executives to unveil the Indiana Biosciences Research Institute, the first industry-led collaborative life sciences research institute in the country.

The Indiana Biosciences Research Institute is a statewide public-private partnership advanced by BioCrossroads and led by Indiana’s life sciences industry, with support from the State of Indiana and partnerships with Indiana’s research universities to discover, develop and deliver biosciences innovations in Indiana. The Institute will serve as the centerpiece project of the BioCrossroads public-private collaboration through its attraction of world-class scientific leaders and life sciences research dollars to Indiana, while focusing on human health solutions for improving the lives of Hoosiers and people around the world. 

“Indiana has built a life sciences ecosystem unlike any other state and faces a new season of opportunity as a result,” said Governor Pence. “The Institute will strengthen Indiana’s reputation as a global life sciences hub and produce breakthroughs that will attract new investment to our state and create good-paying jobs for Hoosiers.”

The Indiana Biosciences Research Institute is the result of leadership from industry executives from Eli Lilly and Company, Dow AgroSciences, Roche Diagnostics, Cook Medical, Indiana University Health and Biomet and the Governor of Indiana, with active support in initial development by BioCrossroads. Indiana’s research institutions, including Indiana University, Purdue University and the University of Notre Dame also are participating in the development process. 

“This Institute comes at a pivotal time in our state’s evolution as a global life sciences leader. With a bioscience sector that now contributes more than $50 billion a year to the Hoosier economy, Indiana is ranked by BIO and Battelle as one of the top five states in the nation in terms of our total number of life sciences companies and employees. Through the Institute, BioCrossroads believes we have found a bold way to raise our game in Indiana by building the platform that will truly take us to the next level of success,” said David Johnson, president and CEO of BioCrossroads, an organization focused on investment, development and advancement of the state’s signature life sciences strengths.

The Indiana Biosciences Research Institute is developing a novel operating model, with industry providing a major source of funding and defining the Institute’s research focus to optimize commercialization opportunities. The Institute also draws on a life sciences industry cluster that is one of the largest and most diverse in the nation, with global companies that are developing next-generation drugs and pharmaceuticals, diagnostics tests, medical devices, cell-based therapies, agricultural biotechnology and animal health and production solutions. This diversity of industry capabilities creates opportunities for Indiana-based life sciences companies to work in collaboration – not competition – toward common scientific discoveries. 

“The research institute will change the bio-landscape of our region,” said Bart Peterson, senior vice president at Eli Lilly and Company. “Indiana’s life sciences companies spend billions of dollars in research and development each year to advance health care innovations for improved human health. The Institute will help us nurture our partnerships across the country and develop more intellectual capital here in Indiana – allowing us to keep more research dollars in the state, attract more federal research funds, and draw top scientific minds to feed our research pipeline and local economies.” 

“Having the best talent and the best scientific minds is crucial for growing our life sciences industry cluster in Indiana,” said Steve Ferguson, chairman of Cook Group, which is celebrating its 50th anniversary this year. “World-class scientific talent at the industry and academic level is one of the state’s most powerful economic development tools. Just as companies like Lilly and Cook Medical started as small, entrepreneurial operations, we expect the Institute to draw the best and the brightest to Indiana to further deepen our life sciences industry roots and grow more business opportunities.”

As part of the Institute development process, industry leaders have defined common scientific interests for research and discovery. The Institute will initially focus on the most pressing global and local interrelated human health issues: cardiovascular disease, diabetes, obesity and nutrition. These interrelated metabolic disorders are a major economic burden and a leading cause of death in the United States. Risk factors, such as high blood pressure and insulin resistance, allow for early disease detection, and timely preventive actions, such as through improved nutrition, and early intervention can slow or prevent the onset of disease. This is an important scientific discovery subject for the approximately 35 percent of Americans who suffer from cardiovascular disease and metabolic disorders, and is a significant risk for Hoosiers who suffer disproportionally from these diseases. 

“We have an opportunity to not only help millions of people around the world who are battling these metabolic disorders, but we can have significant impact on Hoosiers who suffer more than the average American from diabetes and who rank 8th in the nation in terms of obesity,” said Jack Phillips, president and CEO of Roche Diagnostics. “The Indiana Biosciences Research Institute will provide the platform to deliver significant scientific advancements that could improve Hoosier lives.”

“The ability to better understand metabolic disorders impacts the work of nearly every life sciences company in Indiana,” said Antonio Galindez, president and CEO of Dow AgroSciences. “Together, we can develop a deeper understanding of the pathways leading to metabolic disease and apply those discoveries to not only medical interventions, but also to greatly enhanced nutritional sources developed through advanced crop improvement technologies and other advancements in human health.” 

“Patients and clinicians have much to gain by the success of this critically important new venture,” said Daniel F. Evans Jr., president and CEO of Indiana University Health. “The discoveries and inventions generated by the Institute will be used by our physicians to care for patients. To accelerate the pace of innovation from lab bench to patient bedside, we are pleased to make our healthcare system available to researchers to test potential new treatments and therapies.”

The estimated $360-million Indiana Biosciences Research Institute is a non-profit entity that is anticipated to be supported largely by corporate and philanthropic funding with oversight from a largely donor-based board of directors representing the life sciences industry, the state of Indiana, academia and nonprofit donors. The State of Indiana has appropriated $25 million for the biennium for start-up costs. An additional $25 million in start-up funding is being sought from industry and philanthropic sources, which will be used in part to recruit a nationally recognized CEO and research fellows. The remaining capital funding will be sought from corporate and philanthropic sources, and ongoing operating costs will be funded through Institute endowment proceeds, industry-sponsored research and federally funded research.

The Indiana Biosciences Research Institute will attract local and national scientific leaders beginning with the CEO and the recruitment of research “Indiana Fellows.” These research fellows will lead teams of scientists and partner with industry and universities on research projects. These teams will consist of experts across a spectrum of competencies, including bioengineering, bioinformatics, nanotechnology and agriculture. These cross-functional teams will share resources and research laboratories at the Indiana Biosciences Research Institute and will work onsite at industry and research university labs with academic and industry scientists.

“As the scientific discovery process increases in complexity, more companies are looking outside their own walls for multi-disciplined team members to help move innovation forward, at a faster rate, in order to remain competitive in an increasingly global marketplace,” said Jon Serbousek, president, Biomet Biologics.  “A cross-industry, statewide partnership focused on commercially translatable innovation on the cutting edge of basic and clinical science will help the state’s life sciences industry move to the next level.”

“The Indiana Biosciences Research Institute provides a new and exciting opportunity for our research universities to work with our statewide life sciences industry,” said Bill Stephan, vice president for engagement at Indiana University. “The Institute will bolster our ongoing efforts to recruit highly regarded local and national researchers and graduate students. We envision the dynamic of researchers from the Indiana Biosciences Research Institute working alongside researchers in industry or university labs, strengthening long-term collaborative research and funding opportunities.”

More information about the Indiana Biosciences Research Institute can be found at www.indianabiosciences.org.

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Reality Bytes

05/30/2013 07:19 AM |

Thinking personalized medicine?  Think outcomes.

The Pink Sheet reports on a new study by IMS Health shows payers globally are making more drug reimbursement decisions based on real-world evidence - including 25% of more than 100 identified case studies using biopharma industry-generated data.

IMS Health Inc. has developed a report concluding the data is increasingly influencing how payers are covering pharmaceutical products on a global basis.

The report lists more than 100 non-safety cases from around the world where real-world evidence (RWE) informed payer coverage decisions and notes that while "payers are a powerful stakeholder in setting the RWE agenda, proactive pharma engagement matters: manufacturer-generated RWE influenced over 25% of observed decisions."

The report ranks 10 countries based on their supply of real-world evidence, the demand for it and how RWE is applied. On a scoring scale with a maximum of 20, the leading country - the U.K. - scored only an 11, which reflects that "no country has ideal conditions for RWE use in a scalable manner" and "highlights RWE's infancy," the authors state. "Lower scores indicate that RWE is relatively less available or more costly to generate with less consistent or transparent use in decision making. But even in markets with lower scores, RWE is still relevant."

The U.S. is tied for third in the rankings, sharing a score of 8 with the Netherlands. Among the other countries analyzed, Sweden scored 10; France and Italy both scored 6; Denmark, 5; Canada, 4; Germany, 3 and Spain, 2.

The U.S. is unique from the other countries examined in the study in that owners of real-world data "share it without stipulating how it should be used beyond ensuring individual privacy." Most U.S. insurance companies and providers sell data and only use it to support specific analyses about their own populations," giving pharmaceutical companies broad data access that can be used all the way from clinical trial design to post-market commercial support.

But the U.S. market lacks a clear framework for sharing real-world evidence. "Successful U.S. strategies involve evidence platforms and tools that support multiple internal stakeholders. However, without clear frameworks, the channels for external engagement are more nuanced. Only selected payers engage readily on RWE, and FDA regulations on RWE dissemination are more restrictive than in [other] countries. A differentiated engagement approach is needed, requiring creative thought and investment."

In contrast, the report notes that the U.K., Sweden and the Netherlands "all have strong national [health technology assessment organizations], suggesting an impact from concentrated decision making." In these markets, "pharmaceutical companies should set high ambitions for RWE plans, demonstrating value and engaging stakeholders based on a variety of real-life views (e.g. disease, product, class, cross-care settings, long-term outcomes, payer-relevant quality of care indicators). They must fully exploit RWE beyond traditional evaluations to enable commercial strategy, leverage outcomes-based marketing and use innovative evidence tools with local health systems."

The report notes that countries such as France and Italy have significant demand for real-world data, but limited supply.

"France's bold vision includes using RWE for cost-effectiveness assessments and regular class reviews without detailing how extensive data in the health system can be accessed or levered," the authors observe. "In Italy, there is widespread use of pay-for-outcomes or coverage with evidence development (CED), but how these schemes inform coverage or pricing decisions based on the captured data remains unclear. While manufacturers can react to these limited demands for RWE, the more innovative ones might place a bet that the markets will expand RWE use over time. Pharmaceutical companies must develop some RWE capabilities for payer's current focus areas."

The four countries at the bottom of IMS' list - Denmark, Canada, Germany and Span - "may use RWE more in [the] future but face significant hurdles today," including strong data privacy rules and fragmented health care landscapes, the authors write. "In these markets, pharmaceutical companies benefit from engaging directly with selected stakeholders willing to lead on RWE. Given the limited resources of these stakeholders and the large number of manufacturers, developing a clear value proposition and local RWE capabilities are essential to becoming a preferred partner."

Outcomes talk.

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The (Social) Media is the Message

05/29/2013 08:55 AM |

The “Three Cs” of social media are content, context and channel. They are not severable.

The media remains the message.

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Dear Valued Prescriber

05/28/2013 08:45 AM |

As discussed previously (“Thug Regulation”), Walgreens is feeling the hot breath of the DEA on its neck. A new letter is designed to explain and assuage physician concerns over the chain's tighter restrictions for controlled substances – particularly opioids. (According to the California Medical Association, the Walgreens’ policy is in response to recent investigations and actions by the DEA.)

According to the Walgreens missive, “We realize that this process may generate questions and comments from both you and the patient and we will do our best to respond in a professional and courteous manner.  We recognize that sharing appropriate information with our pharmacists may require additional time from you or your office staff and we want to thank you in advance for partnering with us to provide the best care for patients.”

(The complete Walgreens letter can be found here.)

The issue goes beyond the DEA’s behind the scenes efforts to deputize pharmacists to better control controlled substances (and the important issue of access to pain medications). The bigger issue is re-inventing the role of the 21^st century pharmacist.

Some questions to consider:

What will the role of the 21^st century pharmacist be in improving drug safety and medication adherence via more proactive (and remunerated) patient education?

How can pharmacists become better integrated (beyond Med Guides) into the FDA’s Safe Use of Medicines initiative?

When will pharmacy synchronization programs really kick into gear, and how will states help to jump-start these important initiatives?

Stay tuned.

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Thug Regulation

05/24/2013 10:00 AM |

When some pharmacists refused to dispense Plan B (aka, “the morning after pill”) because of their personal moral beliefs, reproductive rights advocates and the media swooped down with all guns ablaze. “Denying access!” they cried. “Abusing their state licenses!” shouted others.

And, of course, there was litigation. In Washington, U.S. District Judge Ronald Leighton ruled the Evergreen State cannot force pharmacies to sell Plan B or other emergency contraceptives, saying the state's true goal was to suppress religious objections by druggists — not to promote timely access to the medicines for people who need them.

(Washington State – as do many states -- requires pharmacies to dispense any medication for which there is a community need and to stock a representative assortment of drugs needed by their patients.)

The state argued that the requirements are legal because they apply neutrally to all medicines and pharmacies, and that they promote a government interest — the timely delivery of medicine, including Plan B, which becomes less effective as time passes.

But Leighton ruled that the state allows all sorts of business exemptions to that rule. Pharmacies can decline to stock a drug, such as certain painkillers, if it's likely to increase the risk of theft, or if it requires an inordinate amount of paperwork, or if the drug is temporarily unavailable from suppliers, among other reasons.

Not surprisingly, today the issue of the dispensing of pain medicines is front and center.  The California Medical Association has received reports from physicians that Walgreens pharmacists are refusing to fill controlled substances prescriptions without additional information from the prescriber.

Physicians are being asked to provide information on diagnosis, ICD-9 codes, expected length of therapy and previous medications tried and failed. Walgreens has also sent letters to prescribers that provide an overview of its newly revised policy on good faith dispensing of controlled substances and cites a pharmacist’s corresponding responsibility to ensure that every prescription for controlled substances is “issued for a legitimate medical purpose.”



“Overreaching!” claim some. “Second-guessing physicians!” say others.

But, unlike the Plan B debate, this isn’t an issue over morality – it’s being driven by Drug Enforcement Agency thuggery. According to the California Medical Association, the Walgreens’ policy is in response to recent investigations and actions by the DEA.

It seems the DEA, frustrated that the FDA is taking too long to decide if hydrocodone combination products should be further restricted, has decided to take matters into its own hands, strong-arming pharmacists into submission.

And, it seems, they’re taking their cue from Congress. West Virginia Senators Manchin and Rockefeller sent a letter to FDA Commissioner Margaret Hamburg earlier this month complaining that the agency is dragging its feet on “upscheduling” drugs containing hydrocodone from Schedule III to Schedule II. Such a move would bring tighter restrictions on a variety of widely used opioid drugs.

Tighter restrictions, that is, for people that really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow FDA regulations.

When you have a hammer, every problem looks like a nail. The DEA sees opioid abuse and seeks to minimize access to them. That’s a law enforcement solution. They mean well – but are behaving like a bull in a china shop.

The FDA is already providing thoughtful solutions that address the problem of abuse without restricting appropriate access. Recent agency decisions such as its ban on generic forms of the non-abuse-deterrent formulation of Purdue Pharma’s OxyContin show the FDA is actively involved in the fight against addiction.

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Why DTC is good for you

05/23/2013 07:22 AM |

Here’s a good briefer from FDA News on the recent Journal of General Internal Medicine study on DTC. The “aha” (both missed and misinterpreted by mainstream media reporting) is that this research does not claim DTC advertising causes physicians to inappropriately prescribe medications.

The FDA’s own research, over many years, confirms that same diagnosis. It’s important. The simple fact of the matter (as opposed to the spin) is that statins are not being prescribed to patients who do not have high cholesterol.

DTC Marketing Study Implies Doctors Overprescribe Statins

A new study on direct-to-consumer (DTC) marketing of statin drugs suggests the prevalence of such ads promotes over-diagnosis in patients that may not be at risk for cardiac events. But the study incorrectly implies that physicians are to blame for inappropriate prescriptions, experts say.

A study of 106,000 adults published recently in the Journal of General Internal Medicine showed consumers exposed to advertisements about statins are 16 to 22 percent more likely to be prescribed the drugs, and 16 to 20 percent more likely to be diagnosed with high cholesterol.

These associations were driven almost exclusively by men and women at low risk for future cardiac events, the study states. Use of the popular cholesterol-lowering drugs may lead to an increased risk of Type 2 diabetes, memory loss or confusion, the FDA says.

But don’t blame physicians, Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and former agency staffer, said Tuesday.

“If you ask your doctor for [AstraZeneca’s] Crestor, they are likely to prescribe Crestor,” he said, adding that he believes the study’s dire conclusions are overblown.

“You either have high cholesterol or you don’t — it’s a simple blood test.”

While reluctant to trumpet brand pharma and its marketing practices, Pitts said anything that drives people to talk to their doctors about symptoms is a good thing and should be applauded.

Drugmakers’ DTC marketing is an ongoing concern at the FDA, with several studies on the issue planned or currently in process. The agency is in the early stages of a survey of healthcare providers about their thoughts on prescription drug advertising and marketing, specifically DTC marketing and how it affects or influences the prescribing of certain medicines.

Earlier this month, the agency launched two studies examining the use of composite score in DTC marketing.

 The Direct-To-Consumer Television Advertising Exposure, Diagnosis with High Cholesterol, and Statin Use study, can be found at www.ncbi.nlm.nih.gov/pubmed/23463454.

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Big D

05/22/2013 09:38 AM |

The American Journal of Managed Care Pharmacy has just published The Economic Impact of Medicare Part D on Congestive Heart Failure, a study looking at impact of pharmaceutical adherence to patient outcomes related to Congestive Heart Failure. Some headlines:

* Improved adherence as a result of the establishment of Part D will save Medicare $2.6 billion annually or $27 billion over ten years (2013-22).

* In addition, reaching recommended levels of adherence (80% or better), would generate Medicare savings of $2 billion annually, or $22 billion from 2013-2022. 

The findings are based on CBO’s new methodology for scoring the impact of increased medicine use.  These savings are a conservative estimate because there is a large amount of literature suggesting that the offsets from adherence in CHF patients would be higher than average.

Big issue. Big numbers. Big opportunity.

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Expanionist Regulatory Policy

05/21/2013 09:02 AM |

The FDA has released draft guidelines on how it intends to regulate expanded access to experimental drugs. The guidance on investigational new drug applications comes in a question-and-answer format; feedback is due by July 1.

Here’s a question -- How about FDA actually approving rare disease NDAs so patients have access for the long term. Giving medicines away for free is not a sustainable business model, nor allow development for the next generation of disease treatments.

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Game of Thrones: Michael Rawlins attacked for joining biotech board

05/20/2013 12:23 PM |

The sense of 'betrayal' over Sir Michael Rawlins appointment as a board member of a biotech firm is funny and sad.

Apparently people believe that Sir Michael, who chaired Britain's NICE organization, did so because he hated drug profits and drug companies.  

Sir Michael has been a pioneer in promoting personalized medicine and finding ways to reduce the time and cost of medical innovation as a way of making medicines more affordable.  

The failure of his critics to understand this is based in ignorance and ideology.   So is their belief that he was a leader in vanguard against commercialization.  


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Let the sun shine ... through?

05/20/2013 08:57 AM |

According to the Washington Post, Sunbathers headed to the beach this summer will find new sunscreen labels on store shelves that are designed to make the products more effective and easier to use. But despite those long-awaited changes, many sunscreens continue to carry SPF ratings that some experts consider misleading and potentially dangerous, according to a consumer watchdog group.

A survey of 1,400 sunscreen products by the Environmental Working Group finds that most products meet new federal requirements put in place last December. The rules from the Food and Drug Administration ban terms like “waterproof,” which regulators consider misleading, and require that sunscreens filter out both ultraviolet A and B rays. Previously some products only blocked UVB rays, which cause most sunburn, while providing little protection against UVA rays that pose the greatest risk of skin cancer and wrinkles.

“The high SPF numbers are just a gimmick,” says Marianne Berwick, professor of epidemiology at the University of New Mexico. “Most people really don’t need more than an SPF 30 and they should reapply it every couple of hours.” Berwick says sunscreen should be used in combination with hats, clothing and shade, which provide better protection against ultraviolet radiation.

Per the FDA, “Labeling a product with a specific SPF value higher than 50 would be misleading to the consumer.” At the time the agency proposed capping all SPF values at 50 because “there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users.”

More than 76,000 men and women in the U.S. will be diagnosed with melanoma this year and 9,480 are expected to die from the aggressive form of skin cancer, according to the National Cancer Institute. The disease, which is often linked to ultraviolet exposure, is usually curable when detected early.

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Pelosi's quote of the week

05/16/2013 02:37 PM |

"The Affordable Care Act is bringing the cost of health care in our country down in both the public and private sector. And that is what is largely responsible for the deficit coming down."
 
-- House Minority Leader Nancy Pelosi

Meanwhile, Philip Klein reports on the new CBO cost projections for implementation of the health care law:

When President Obama was selling his health care legislation to Congress, he declared that “the plan I’m proposing will cost around $900 billion over 10 years.” But with the law’s major provisions set to kick in next year, a new analysis by the Congressional Budget Office projects that the law will cost double that, or $1.8 trillion.

What accounts for the dramatic difference? It’s true that at the time of passage, the CBO said the gross cost of the law’s provisions to expand insurance coverage would be $940 billion over a decade. But as many critics of the health care law pointed out at the time, this number was deceptive because it estimated spending from 2010 through 2019 even though the program's major spending provisions weren’t scheduled to go into effect until 2014. Effectively, the original estimate measured the cost of six years of Obamacare instead of 10.

Now, as implementation approaches, CBO has released projections for the 2014 to 2023 budget window — the first actual decade of Obamacare — and the gross cost projection is $1.8 trillion.



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Never Mind thecIRS...Making The Case ForvAn FDa Reboot

05/15/2013 06:46 PM |

In case you Mr. Scott Gottlieb and Peter Huber did a masterful job of presenting the case for accelerating medical innovation by rebooting the FDA http://www.npr.org/2013/05/09/182594801/debate-is-the-fdas-caution-hazardous-to-our-health  Read More & Comment...

The Designation Dilemma

05/15/2013 10:12 AM |

Question: Who is supposed to benefit from “breakthrough designations?”

(Breakthrough status was created in the 2012 FDA Safety and Innovation Act as a way of speeding development of products showing a dramatic improvement over existing therapies.)

Well, as is so often the case, where you stand on this question depends on where you sit.

If you sit in Congress or at the FDA, the first and most important answer is patients.

If you sit in a boardroom the first answer is likely to be stockholders.

Both answers are important -- but which is more important?

The question is, where lies the real value of a breakthrough designation? There can be more than one winner – but there must be a primary focus.

According to the Pink Sheet, As the number of sponsors holding breakthrough designations grows, so are the questions from analysts and investors about the value of the emerging program.

Several companies were questioned during their first quarter earnings calls about the value of the designation and its potential impact on the associated products. However, company officials did not have much to say about the effects it could have on a development program.

Merck & Co. Inc. announced it had received a breakthrough designation for its anti-PD1 antibody lambrolizumab (for treatment of advanced malignant melanoma) on April 24.

On May 2, Bernstein Research analyst Tim Anderson observed that Merck officials “did not provide clear answers” about what breakthrough means and “in our view, this designation does not actually mean much.”

To patients?  No. To investors. Now, to be fair, that’s their business. But it sounds awfully cold.

Leerink Swann analyst Seamus Fernandez, who also asked about the breakthrough program during the call, concluded that the designation has no real downstream value – stating that the Merck breakthrough announcement “on its own has no impact on our expectations for relative anti-PD1 market share across multiple tumor types.”

“Downstream value?” For who? A new therapy for advanced malignant melanoma has plenty of value … to patients.

The Pink Sheet: While the ultimate value of the designation has yet to be tested, some analysts are still seeing significance that the product was deemed a breakthrough aside from whether it will actually accelerate development.

Is this gaming the system?  It certainly could evolve that way. If just getting the designation helps to bump stock price, will companies apply for breakthrough status regardless of whether or not it seems therapeutically appropriate? One need only study the benighted history of “accelerated approval” to be somewhat dubious of motivation.

And wither "Special Medical Use?"

Kudos then to John Leonard, AbbVie senior VP and chief scientific officer, who downplays the hype surrounding breakthrough status. He reminded analysts on its quarterly call that “it doesn’t necessarily predict a regulatory outcome, however, or accelerate the review,” but does allow an opportunity for good planning.

Thank you, John

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Fine, and you?

05/14/2013 09:29 AM |

Indian generics manufacturer Ranbaxy pleaded guilty on Monday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the US department of justice.

The settlement is its largest-ever with a generic drugmaker over drug safety, according to the US government. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims.

Ranbaxy USA pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations that did not meet safety standards and to four counts of making material false statements.

In 2008, the FDA banned the company from selling about 30 drugs in the United States after it found manufacturing deficiencies at facilities in India. In 2009, the FDA had accused the company of falsifying data and test results in drug applications and halted reviews of drugs made at a plant in northern India.

The company has since grappled with other manufacturing problems. In November 2012 it recalled some generic Lipitor, known as atorvastatin, in the United States after certain batches were found to contain glass particles. It has since resumed manufacturing the widely used cholesterol lowering medicine.

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Where there's smoke there's ire

05/14/2013 09:19 AM |

Yesterday Republicans on the House Energy and Commerce Committee sent a letter to Food and Drug Administration Commissioner Dr. Margaret Hamburg asking for the agency to provide information on former Johnson & Johnson executive Dr. Leona Brenner-Gati's role at the agency and the circumstances surrounding her resignation on May 3rd.

The letter points out a number of discrepancies, including that despite the fact that between February and April, Dr. Brenner-Gati was listed as the FDA's Acting Deputy Commissioner for Medical Products and Tobacco on the agency's public calendar, she was not scheduled for any significant meetings. Moreover, although Brenner-Gati's name remained on the public calendar into April, and the FDA's Office of Medical Products and Tobacco website still listed her as acting deputy commissioner when it was updated on March 22, the agency's organizational chart began listing the position as vacant on March 4, according to the letter. Reuters adds that FDA spokesperson Erica Jefferson declined to provide comment on the letter.

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Are iPads the new Vioxx?

05/10/2013 09:40 AM |

Gianna Chien is somewhat different from all the other researchers reporting on their work today to more than 8,000 doctors at the Heart Rhythm Society meeting.

Chien's study found that Apple Inc.’s iPad2 can, in some cases, interfere with life-saving heart devices because of the magnets inside. Source: Gianna Chien

Chien is 14, and her study -- which found that Apple Inc. (AAPL)’s iPad2 can, in some cases, interfere with life-saving heart devices because of the magnets inside -- is based on a science-fair project that didn’t even win her first place.

The research offers a valuable warning for people with implanted defibrillators, which deliver an electric shock to restart a stopped heart, said John Day, head of heart-rhythm services at Intermountain Medical Center in Murray, Utah, and chairman of the panel that reviews scientific papers to be presented at the Denver meeting.

If a person falls asleep with the iPad2 on the chest, the magnets in the cover can “accidentally turn off” the heart device, said Chien, a high school freshman in Stockton, California, whose father is a doctor. “I definitely think people should be aware. That’s why I’m presenting the study.”

Trudy Muller, an Apple spokeswoman, declined to comment on the study in an e-mail, referring questions about the iPad2’s safety to its online product guide. The guide cautions users about radio frequency interference, suggests that patients with pacemakers keep the iPad at least six inches away and says they should be turned off in health-care facilities when instructed by staff or posted signs.

Medtronic Inc. (MDT), the leading manufacturer of defibrillators, said its testing hasn’t found any risks from iPad technology when used according to the manufacturer’s instructions. The Minneapolis-based company does tell patients to avoid placing any magnets near the area where their devices are implanted.

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The ins and outs of drug disposal

05/09/2013 09:36 AM |

Via the Huffington Post …

The Wrong Way to Dispose of Drugs

In late April, towns across the country participated in National Prescription Drug Take-Back Day -- a nationwide event organized by the federal Drug Enforcement Agency. Local law enforcement personnel and community groups were on hand to collect and dispose of unneeded and expired prescription drugs.

Most of us don't think about the old pill bottles cluttering up our medicine cabinets. But there are actually some important safety, privacy and environmental issues surrounding the disposal of unused prescription drugs. In this respect, take-back events are worthy endeavors. But some lawmakers want to go farther and make take-back programs mandatory.

Alameda County, California, recently passed an ordinance that would do just that. The county's new law requires pharmaceutical companies to develop, manage and pay for a new local drug take-back program.

There's good reason to believe very few people will participate in this program. It is also likely to result in higher drug prices and will produce few environmental benefits.

The driving force behind the take-back programs is concern for the environment. But less than 10 percent of pharmaceutical contamination is the result of improper disposal of unused medications. The vast majority of pharmaceutical contamination results from drugs being excreted by humans into waste water -- a problem take-back programs obviously can't address.

Encouraging proper household disposal is a superior approach to tackling this problem. Trash collected from homes is usually incinerated or put into double-lined municipal landfills equipped with collection systems that keep medicines from leaching into the ground.

Consumers do need to be educated about the risks of drug disposal. For instance, some people still improperly dispose of drugs in the sink or flush them down the toilet. In general, unneeded prescription drugs should be crushed, put in bags with sawdust, kitty litter or other fillers that make them unappealing to pets and children, and then thrown out in the trash. For privacy, bottle labels should be removed and destroyed before disposal.

Home disposal also avoids the dangerous "concentration" of pharmaceuticals. When many drugs are collected all at once, there's a greater risk they will be stolen or otherwise improperly used.

Alameda's law explicitly prohibits drug makers from charging any extra fees to pay for the program. But the simple fact is that consumers across the country will pay higher prices to cover the cost of the Alameda program.

And very few people are expected to actually participate. Vancouver, B.C.'s take-back program is often cited as a model, but a decade after its launch in 1997, a survey found that only 21 percent of respondents had made use of the program -- hardly justifying the cost and new bureaucracy.

Well-publicized, one-time take-back programs like the one in late April are a good way to raise awareness and encourage people to go through their medicine cabinets and dispose of unwanted pills. But the best "next step" is to educate consumers about proper and safe household disposal. There's no justification for the kind of permanent and mandatory take-back program that Alameda County is proposing.

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.

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Intellectual Dishonesty

05/08/2013 09:14 AM |

U.S. District Judge Edward Korman, asked by the government on Tuesday to freeze his plan giving teenage girls broader access to morning-after birth control, instead seized the chance to accuse health officials of taking steps that would end up hurting poor people and improve their chances of prevailing in a protracted legal fight with reproductive rights advocates.

At a hearing in federal court in Brooklyn, Korman told an assistant U.S. attorney that the FDA ruling was a cynical attempt to "sugarcoat this appeal of yours."

Korman said he would issue a ruling before the end of the week on the request to stay his order. But he left little doubt about where he stood, accusing the Justice Department lawyer of "intellectual dishonesty" and calling further delays in the 12-year-old case "a charade."

"The poor, the young and African-Americans are going to be put in the position of not having access to this drug," he said. Making the same point earlier, he asked, "Is that the policy of the Obama administration?"

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Medical Innovation Is Driving Down Health Care Spending

05/07/2013 01:00 PM |

A new set of articles in Health Affairs about the declining rate of health care spending increases debate whether it's the recession or a slow down in the use of new technology.  The authors conclude "that a host of fundamental changes—including less rapid development of imaging technology and new pharmaceuticals, increased patient cost sharing, and greater provider efficiency—were responsible for the majority of the slowdown in spending growth."

It is just the opposite.  

The continuing decline since 2000 is the result of people living longer healthier lives due in large part to new devices and medicines for previously untreatable diseases.  In particular, the decline in the spending rates correlates strongly with steep declines in morbidity and mortality from cancer.   If you reduce the amount of people dying and being treated from a leading cause of death and illness you are going to slow the climb in health care spending.  

Consider the following:
 

• Over the past 20 years, cancer deaths in the United States have dropped 30 percent, faster than in any time in history.
• The percentage of cancer patients who have to be hospitalized has been cut in half.  The number of cancer survivors has more than doubled from about 6.8 million to 14 million today.  
• That translates into 43 million additional life years worth $4.2 trillion in income. 

Finally, as Frank Lichtenberg's recently updated paper on the contribution of new cancer therapies to longer life and greater value notes that "the cost of new cancer drugs is less than 1% of the value of the mortality reduction they yielded."

We need to reboot the way we pay for health care to capitalize on and encourage even more innovation.  That, not a slowdown in the adoption of such technologies, will continue to make health care more affordable. 

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What would Anthony Weiner do?

05/07/2013 08:49 AM |

Viagra. Web sales.

Discuss.  Read More & Comment...