FDA’s Impact on Pharmaceutical Innovation:
A lecture by Neil Flanzraich

Tuesday, April 14, 2015 12:00 PM
Lectures and Panels
2014-2015
Griswold Hall, 110
Harvard Law School, Cambridge, MA

The Petrie-Flom Center will host a lecture by Neil Flanzraich, who graduated from HLS in 1968 and was appointed by Dean Martha Minow…

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Health Law Workshop: Rachel Sachs

Monday, April 13, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Presentation Title: "Prescription Drug Reimbursement as Innovation Incentive" Rachel Sachs is an Academic Fellow at the Petrie-Flom Center. She earned her…

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RESCHEDULED: Health Law Workshop: Liran Einav

Monday, March 23, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Download the Presentation: "The Response of Drug Expenditure to Non-Linear Contract Design: Evidence from Medicare Part D" (co-authors, Amy Finkelstein and…

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Medical scope now tied to Wisconsin superbug outbreak:

Al Jazeera America, March 4, 2015
by Karen Foshay

LOS ANGELES – A medical device called a duodenoscope that's been linked to recent deadly superbug infections across the country was also connected to a 2013 outbreak at a Wisconsin medical facility…

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McDonald’s Moving to Limit Antibiotic Use in Chickens

New York Times, March 4, 2015
by Stephanie Strom

McDonald’s said on Wednesday that it would begin using chickens that are not raised with antibiotics used to treat humans, a move likely to put pressure on competitors of the fast-food chain, which now…

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Heroin overdose death rates quadrupled since 2000, says CDC:

Al Jazeera America, March 4, 2014
by Marisa Taylor

Concern over the U.S. drug epidemic has focused on the growing abuse of prescription painkillers like oxycodone. But if overdose deaths are any indication, heroin may still be a bigger…

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Execution of Georgia Woman Is Postponed Indefinitely

New York Times, March 3, 2015
by Alan Blinder

ATLANTA — The state of Georgia on Monday night indefinitely delayed the execution of the only woman on its death row after officials noticed that the drug to be used…

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Vermont Tackles Heroin, With Progress in Baby Steps

New York Times, February 25, 2015
by Katherine Q. Seelye

[...] Officials here say they have made strides against addiction, a nationwide scourge that is particularly acute across New England. About 40 percent more Vermonters are seeking treatment for addiction…

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A Faster Way to Try Many Drugs on Many Cancers

New York Times, February 25, 2015
by Gina Kolata

[...] The studies of this new method, called basket studies because they lump together different kinds of cancer, are revolutionary, much smaller than the usual studies, and without control groups…

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Malaria in Widening Area Resists Drug, Study Finds

New York Times, February 19, 2015
by Thomas Fuller

BANGKOK — The world’s best drug for treating malaria, a medicine that is the key to saving millions of lives in Africa and beyond, is losing its efficacy in a much…

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Blood transfusions show early promise as possible Ebola cure:

Al Jazeera America, February 16, 2015
by Amy Maxmen

[...] With the trials coming a year after the start of the outbreak in Guinea, blood treatments will not make much of a dent in the overall death toll, which…

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Female Libido Pill Fires Up Debate About Women And Sex

NPR, February 16, 2015
by Rob Stein

[...] Women like Price, who see their decreasing sex drive as a problem, are at the center of an intense, emotional debate that's been raging for years over whether the Food…

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Academic Fellow Rachel Sachs Presents at 2015 Works-in-Progress in Intellectual Property Colloquium

Petrie-Flom Center, February 7, 2015

Petrie-Flom Academic Fellow Rachel Sachs presented her paper, "Innovation Law and Policy: Preserving the Future of Personalized Medicine," at the 2015 Works-in-Progress in Intellectual Property (WIPIP) Colloquium.  Held this year…

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Third Annual Health Law Year in P/Review collaborative blogging with Health Affairs

Petrie-Flom, February 5, 2015

The Third Annual Health Law Year in P/Review was a big success!  Video will be posted on our website shortly, but our presenters will be posting on their respective topics…

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Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions,

Petrie-Flom Center, February 5, 2015

On January 19 - 21, 2015, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Regulatory Foundations, Ethics, and Law Program of Harvard…

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Americans are ignoring the science and spending billions on dietary supplements

Washington Post, February 4, 2015
by Jason Millman

Dietary supplement fans got a big "buyer beware" warning this week when the New York attorney general's office ordered GNC, Target, Walgreens and Wal-Mart to pull a number of store-brand products from their shelves,…

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To Protect His Son, A Father Asks School To Bar Unvaccinated Children

Kaiser Health News, February 3, 2015
by Lisa Aliferis

[...] Krawitt is taking action of his own. His son attends Reed Elementary in Tiburon, a school with a 7 percent personal belief exemption rate. (The statewide average in California…

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Gov. Chris Christie, Sen. Rand Paul Jump Into Vaccine Debate

NPR, February 2, 2015
by Eyder Peralta

As the country deals with what the Centers for Disease Control and Prevention is calling a record number of measles cases, New Jersey Gov. Chris Christie, a rumored 2016 presidential contender,…

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Ebola Drug Trial Is Halted for Lack of Patients

New York Times, February 1, 2015
by Andrew Pollack

A clinical trial in Liberia of a drug to treat Ebola has been halted because of a sharp decline in the number of people infected with the virus, and studies…

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Third Annual Health Law Year in P/Review

Friday, January 30, 2015 7:45 AM - 5:00 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Couldn't make it in person? Check out the individual sessions in the videos linked above! The Third Annual Health Law…

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Dying to Be Free:

HuffPost, January 28, 2015
by Jason Cherkis

[...] At Recovery Works, Patrick’s former treatment facility, his name and photo were added to a memory wall in a common room — another fatal overdose in a system full…

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Obama to Unveil Research Initiative to Develop Tailored Medical Treatments

New York Times, January 30, 2015
by Robert Pear

WASHINGTON — President Obama on Friday will announce a major biomedical research initiative, including plans to collect genetic data on one million Americans so that scientists can develop drugs and…

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Elizabeth Warren’s bill to deter pharma wrongdoing may be a flawed fix:

Al Jazeera America, January 29, 2015
by Elijah Wolfson

[...]  Sen. Elizabeth Warren, D-Mass., is expected to introduce in Congress the Medical Innovation Act, designed to funnel additional funds toward the NIH. The mechanism is straightforward: Every time a pharmaceutical…

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Program Manager

Program Manager
Harvard Multi-Regional Clinical Trials Center

Deadline: Open until filled.

The mission of the MRCT Center at Harvard is to improve the design, conduct, and oversight of multi-regional clinical trials, especially trials sited in or involving the developing world; to simplify research through the use…

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Academic Fellow Rachel Sachs Guest Lecturing in Reading Group at Harvard Law School

Petrie-Flom Center, January 22, 2015

Petrie-Flom Academic Fellow Rachel E. Sachs will be a regular guest lecturer in a reading group at Harvard Law School, co-taught by with Professors Terry Fisher and Mark Wu in Spring 2015, on…

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Supreme Court Rules in Favor of Teva Over Patent for Multiple Sclerosis Drug

New York Times, January 20, 2015
by Reuters

WASHINGTON — The Supreme Court on Tuesday ruled that Teva Pharmaceutical Industries could still benefit from patent protection for a multiple sclerosis drug, dealing a blow to makers of generic…

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Rocketing vaccine cost warning:

BBC News, January 20, 2015
by James Gallagher

A report by the charity says there has been a 68-fold increase in prices between 2001 and 2014. It accused the pharmaceutical industry of overcharging and highlighted cases where rich…

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Gilead’s India Patent Snag May Spur More Low-Cost Sovaldi Copies

Bloomberg, January 15, 2015
by Ketaki Gokhale

The Indian patent office’s rejection of a key patent for Gilead Sciences Inc. (GILD)’s Hepatitis C treatment Sovaldi may pave the way for more low-cost copies in the country, potentially aiding…

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Johnson & Johnson Will Make Clinical Data Available to Outside Researchers

New York Times, January 14, 2015
by Katie Thomas

The health care giant Johnson & Johnson has agreed to make detailed clinical trial data on its medical devices and diagnostic tests available to outside researchers through a collaboration with Yale University, making…

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U.S. Funding of Health Research Stalls As Other Nations Rev Up

NPR, January 13, 2015
by Richard Harris

Though the United States is still leading the world in research related to diseases, it is rapidly losing its edge, according to an analysis in the American Medical Association's flagship journal JAMA. If…

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First biosimilar drug set to enter US market:

Nature, January 13, 2015
by Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The FDA is expected to make a final decision by May. But even as Sandoz prepares to sell its drug in the United States, it is embroiled in a…

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In Africa, a Decline in New Ebola Cases Complicates Vaccine Development

New York Times, January 9, 2015
by Andrew Pollack

As authorities and drug companies hurriedly prepare to begin testing Ebola vaccines in West Africa, they are starting to contemplate a new challenge: whether an ebbing of the outbreak could make it…

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Why is it easier to study heroin than marijuana?

Al Jazeera America, January 9, 2015
by Jacob Ward

An enormous number of people are using marijuana. Nearly 20 million people say they've used it in the prior month, according to the 2012 National Survey on Drug Use and Health, making…

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FDA Advisory Panel Backs First Potential ‘Copycat’ Drug

Kaiser Health News, January 8, 2015

KHN Morning Briefing: Summaries of health policy coverage from major news organizations. If the government accepts the recommendation, it could mean millions in savings for consumers who need expensive drugs.…

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Antibiotics:

BBC News, January 7, 2015
by James Gallagher

The decades-long drought in antibiotic discovery could be over after a breakthrough by US scientists. Their novel method for growing bacteria has yielded 25 new antibiotics, with one deemed "very…

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India’s deadly medicine:

Al Jazeera America, January 6, 2015

India has seen a dangerous surge in the abuse of prescription drugs. Pharmacies are selling cocktails of medical-grade drugs to addicts for up to a tenth of the cost of…

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Drug-resistant tuberculosis patients face dwindling treatment options:

Al Jazeera America, December 29, 2014
by Katya Cengel

[...] Once the leading cause of death in the United States, tuberculosis rates in the U.S. have been in decline for decades. Effective drug treatments in the 1940s all but…

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Group Sues Aetna, Claiming Discrimination Against H.I.V. Patients

New York Times, December 22, 2014
by Katie Thomas

A consumer group has sued the health insurer Aetna, claiming that it discriminated against patients with H.I.V. when it required them to obtain medications exclusively through its own mail-order pharmacy. The lawsuit, filed…

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Charges in pharmacy case indicate US sees crime ring:

Boston Globe, December 18, 2014
by Milton J. Valencia

Federal prosecutors allege that the pharmacists who ran the New England Compounding Center essentially ran the company like a criminal enterprise, engaging in a conspiracy to defraud customers with shoddy…

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Even With Coverage Expansion, Access To Mental Health Services Poses Challenges

Kaiser Health News, December 18, 2014
by Lisa Gillespie

Even though more Americans have access to health insurance because of the health law, getting access to mental health services can still be challenging. A new report concludes that despite the 2008…

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Houston doctor sued for trading prescriptions for sex

Houston Chronicle, December 12, 2014
by St. John Barned-Smith, quoting I. Glenn Cohen (Faculty Director)

[...] Legal experts who specialize in medical ethics said the allegations and actions captured on film were "egregious." Medical standards prohibit doctors from engaging in sexual relationships with patients. "This…

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Drastic drop in global malaria deaths:

Al Jazeera America, December 9, 2014

Malaria deaths have dropped dramatically since 2000 and cases are falling steadily thanks to more people being diagnosed and treated, the World Health Organization (WHO) said on Tuesday. Yet progress…

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Nursing Homes Rarely Penalized For Oversedating Patients

NPR, December 9, 2014
by Ina Jaffe

Antipsychotic drugs have helped many people with serious mental illnesses like schizophrenia or bipolar disorder. But for older people with Alzheimer's or other forms of dementia, they can be deadly.…

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‘Superbugs’ Kill India’s Babies and Pose an Overseas Threat

New York Times, December 3, 2014
by Gardiner Harris

AMRAVATI, India — A deadly epidemic that could have global implications is quietly sweeping India, and among its many victims are tens of thousands of newborns dying because once-miraculous cures no…

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Costly Hepatitis C Treatments Help Drive 12 Percent Drug Spending Jump

Kaiser Health News, November 20, 2014
by Roni Caryn Rabin

After several years of modest increases, American spending on medications is projected to shoot up by 12 percent this year, pushing the nation’s drug bill to between $375 billion and…

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Gilead Buys Shortcut For FDA Drug Review For $125 Million

NPR, November 19, 2014
by Scott Hensley

[...] Duke health economist David Ridley, one of the intellectual architects behind the voucher law, told Shots that he "was delighted" by the sale. "I think we're much closer to…

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Laws Spreading That Allow Terminal Patients Access To Experimental Drugs

Kaiser Health News, November 18, 2014
by Michelle Andrews

Earlier this month, Arizona voters approved a referendum that allows terminally ill patients to receive experimental drugs and devices. It’s the fifth state to approve a “right-to-try” law this year. Supporters say…

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Obamacare May Mean High Drug Costs For Floridians With HIV

Miami Herald, October 31, 2014
by Nicholas Nehamas

[...] Last spring, two nonprofit groups filed a federal civil rights complaint alleging that some Florida insurers were discriminating against people with HIV by charging “inordinately high” rates for HIV…

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In a First, Mass. Town May Prohibit Tobacco Sales

Boston Globe, October 28, 2014
by Kay Lazar

The Central Massachusetts town of Westminster would become the first community in the state, and perhaps the nation, to ban all tobacco sales under a proposal made public Monday that regulators…

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Ebola Vaccine, Ready for Test, Sat on the Shelf

New York Times , October 23, 2014
by Denise Grady

Almost a decade ago, scientists from Canada and the United States reported that they had created a vaccine that was 100 percent effective in protecting monkeys against the Ebola virus. The results…

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