Why we should listen to Martin Shkreli

Why we should listen to Martin Shkreli

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The public already knows that the medicines we make can be enormously valuable. They just think we charge too much for them, and it is hard to find a good argument that we aren’t doing that. Take Sovaldi — Gilead launched a cure for the scourge of hepatitis C, something everyone wanted, priced it at what the market couldn’t refuse, and then faced the inevitable backlash.

In good years, innovation in the pharmaceutical industry amounts to 30 to 40 new products. Yet we’re charging the world for the 50,000 candidates that it took us to get to those 30 or 40. And that ratio is unlikely to change for as long as the market will bear the increasing cost. Unfortunately, there are signs that the market and public opinion have changed, and the lobbyists have chosen to ignore them.

The answer to fixing the pharmaceutical industry’s reputation doesn’t lie in vilifying Shkreli. He just supersized its business model, one that the lobbyists are defending at all costs.

Instead, we must choose to be different. We need to regain our ethical core and to be, once again, known as ethical pharma. And that’s where we need real leadership.

Health Affairs Web First: US Six-Month Drug Market Exclusivity Extensions Could Yield Nearly $100 Million

http://healthaffairs.org/blog/2017/01/18/health-affairs-web-first-us-six-month-drug-market-exclusivity-extensions-could-yield-nearly-100-million/

For the past few years, US lawmakers have considered legislation that would grant six additional months of market exclusivity for previously approved drugs that have been successfully tested and subsequently approved by the Food and Drug Administration (FDA) for treating rare diseases. This proposal is intended to incentivize pharmaceutical manufacturers to invest in rare disease research.

A new study, released by Health Affairs as a Web First, analyzed the thirteen supplemental applications approved by the FDA that earned rare disease status from 2005 through 2010 to estimate the costs of the clinical trials and potential economic gain arising from a six-month exclusivity extension. According to the authors, Aaron S. Kesselheim, Ben Rome, Ameet Sarpatwari, and Jerry Avorn, the median discounted financial gain for each drug would have been $94.6 million, with blockbuster drugs predictably enjoying the highest returns. The authors’ analysis also suggests that these manufacturers had spent a median of $29.8 million on trials that gained supplemental approval for rare disease indications.

“These results confirm that market exclusivity extensions can generate substantial returns to the manufacturers that are eligible for the incentive — sums that are generally much greater than the cost of performing the requisite clinical trials,” the authors conclude. As a result, “this solution could prove costly to the health care system.” They add, “Any proposal to extend market exclusivity protections in the US prescription drug market should undergo rigorous analysis that weighs the benefits of predicted investment in research against the costs of the incentives to governmental and private-sector payers.”

The authors are all affiliated with the Program on Regulation, Therapeutics, and Law (PORTAL) at the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School.

This study, which was supported by the Laura and John Arnold Foundation, will also appear in Health Affairs’ February issue.

Presidential candidates in fantasy land over health care

https://www.publicintegrity.org/2015/09/28/18071/presidential-candidates-fantasy-land-over-health-care

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The drug companies always win, which is why Americans pay far more than citizens of any other country for prescription medications. We pay exactly 100 percent more per capita for pharmaceuticals than the average paid by citizens of the 33 other developed countries that comprise the Organization for Economic Cooperation and Development (OECD).

Obama also once supported drug re-importation, as did Sen. John McCain, the Arizona Republican who lost to Obama in the 2008 presidential election. In 2012, two years after the passage of the Affordable Care Act, McCain teamed up with Sen. Sherrod Brown, (D-Ohio) in another attempt to get Congress to pass a drug re-importation bill.

When it became clear that his bill would not pass, McCain took to the floor to denounce the ability of well-financed special interests to control the federal government.

“What you’re about to see is the reason for the cynicism that the American people have about the way we do business in Washington. (The pharmaceutical industry)… will exert its influence again at the expense of low-income Americans who will again have to choose between medication and eating.”

Don’t expect that to change anytime soon. As long as interest groups can spend unlimited amounts of money to influence elections and can hire hundreds of lobbyists to do their bidding, millions of Americans will have to decide between health care and eating, while executives and shareholders get richer and richer.

21st Century Cures Act: 4 health industry impacts summarized

http://www.healthcaredive.com/news/21st-century-cures-act-explained/431491/

On Wednesday, the Senate voted 94-5 to pass the long-awaited 21st Century Cures Bill. As it has backing from the current White House administration, President Barack Obama is expected to sign the legislation into law.

The law has been called the “most important bill of the year” by Senator Lamar Alexander (R-TN), as Politico Pulse reported Tuesday. The bill, while bipartisan, is not without controversy. While the House version of the legislation passed swimmingly with a vote of 392-26, the bill did have its share of opponents in the Senate– including Sen. Elizabeth Warren (D-MA) and Sen. Bernie Sanders (I-VT) – who think the bill is too favorable to pharmaceutical companies. Both Sanders and Warren were among the five Senators to vote against the measure.

And as Modern Healthcare’s Merrill Goozner notes in an editorial, it’s likely the true impact of the bill won’t be known right away but will be realized as the years pass. “The final details of the 996-page legislation…weren’t known until five days before it passed,” Goozner wrote.

About three years of work and efforts from 1,400 lobbyists for 400 companies went into the making of this $6.3 billion package. It seeks to deliberately speed medical research and treatments. Because seemingly no healthcare legislation can be a reasonable length (it’s about 90 pages longer than the ACA) and because nothing in healthcare is simple, we’ve summarized some of the notable implications of the bill in four buckets: Health IT, mental health, FDA reform and research and care funding.

What happens when you don’t price-regulate drugs? Just look at the United States.

http://www.vox.com/science-and-health/2016/11/30/12945756/prescription-drug-prices-explained

Americans aren’t buying lots more drugs. We’re just spending more on the ones we do buy.

There isn’t much evidence that Americans use an inordinately high amount of prescription drugs. It’s just that when we buy prescription medications, we pay more for the exact same product.

The players who are set to influence Trump on health care

The players who are set to influence Trump on health care

It’s customary in the nation’s capital to hail members of the incoming administration by telling everyone in town how close you are to them. So many in conservative Washington lobbying circles and elsewhere are busy touting their relationships with President-elect Donald Trump and his advisers.

There’s a benefit to proximity to power, especially now. At a time when nobody really knows how the Trump administration will regulate drugs and medical devices, fund scientific research, or repeal or replace the Affordable Care Act, relationships with the newcomers are viewed as critical to getting one’s issues on the table.

Donations don’t hurt, either.

Trump’s transition team is a moving train, so influencers are likely to jump aboard fast. Here’s STAT’s look at people and organizations in health care and science who are likely to have influence with a Trump presidency — and who else might benefit.

Drug prices tug on the economy of healthcare

http://www.fiercehealthcare.com/finance/drug-prices-tug-economy-healthcare?mkt_tok=eyJpIjoiTmpjd1pURm1NR0ZqTlRWbSIsInQiOiI5MkdaMWJlaGV4dlppeWNkY1NqNTNtTFJ1MFlrcWtQQWxcL2hvYWVUK3lmNEJRT1lCVTJLQTFwdGFcL0dLWWlGMnBzbGNQbXhDdnFDVUdsdkthR3Y4UzJIVm5sT25iNHJmYWd2aGlFXC9ycVNDST0ifQ%3D%3D&mrkid=959610&utm_medium=nl&utm_source=internal

Money Pills

Drug prices continue to bedevil the economics of the U.S. healthcare system in a variety of ways.

Prescription drug prices rose 7 percent between September 2015 and September of this year, according to a new report (.pdf) from the Altarum Institute’s Center for Sustainable Healthcare Spending. No other category rose more than 2.9 percent. Hospital prices rose just 1.2 percent, although that’s up significantly from the 0.7 percent annual increase between September 2014 and September of last year.

Meanwhile, Altarum’s healthcare spending report (PDF) tells a slightly different story. Prescription drug spending rose only at a 4.5 percent annual rate between September 2015 and August of this year. That’s down from the 7.2 percent growth rate from September 2014 to 2015, and the 12.4 percent rate between August 2013 and 2014.

However, hospital spending grew at a 6.6 percent annual rate in September, up from 3.4 percent between September 2014 and 2015. That’s higher than the overall 5.5 percent growth rate.

That dovetails with forecasts that U.S. healthcare spending will reach 20 percent of the gross domestic product (GDP) by the middle of next decade. According to Altarum, it currently amounts to 18.2 percent of GDP. But another report suggested that the Affordable Care Act will actually cut healthcare spending over the long term by $2.6 trillion.

The report, which is closely read by many healthcare policy experts but gains little attention in most media circles, raised some concerns from advocacy groups.

Drug companies just scored a big election victory

https://www.washingtonpost.com/news/wonk/wp/2016/11/09/drug-companies-just-scored-a-big-election-victory/?utm_campaign=CHL%3A+Daily+Edition&utm_source=hs_email&utm_medium=email&utm_content=37396635&_hsenc=p2ANqtz-_W9hw9hWlg0AQFUq1cLUPfn0SXReW9k_cFDC9jbI6Zl4cBvWUVMRBRYn4CTOFOJ73ZuwJiGhF17XPX8efxYaSLMidFSA&_hsmi=37396635

California voters rejected a closely watched ballot initiative aimed at capping how much most state-funded health insurance programs pay for prescription drugs, a possible bellwether of the lack of political appetite for more widespread policies to tackle high drug prices.

State agencies would have been barred from paying more than the U.S. Department of Veterans Affairs does for prescription drugs. VA gets at least a 24 percent discount off the average manufacturer’s price of a drug and is insulated against price hikes larger than inflation.

Proposition 61 was losing with just 46 percent of the vote Wednesday morning, with more than 90 percent of precincts reporting.

The ballot measure was narrowly constructed and would have applied to an estimated 4.4 million people. Still, it had attracted national attention and $109 million in opposition funding, led by the pharmaceutical industry.

It was, in many ways, a test of Sen. Bernie Sanders’s (I-Vt.) sway and of the viability of a key piece of his agenda, which has involved repeated attacks on the pharmaceutical industry over drug pricing. He appeared at last-minute rallies in Sacramento and Los Angeles on Monday to support the measure, called Proposition 61.

POLITICO-Harvard poll: Americans blame drug companies for rising health costs

http://www.politico.com/story/2016/09/americans-blame-drug-companies-for-rising-health-cost-poll-228866?utm_campaign=KHN%3A+Daily+Health+Policy+Report&utm_source=hs_email&utm_medium=email&utm_content=35091656&_hsenc=p2ANqtz-8PbV9cRcxweGuejnRZArmy5BpOsVlplZlnpP5Tlh3Bb4D0hvTxsoCG-nghADRTV3uBXXBbgZHO8RPcxFGbLEAOLxGfVw&_hsmi=35091656

A pharmacist is pictured. | Getty

The poll found 43 percent of Americans are “very or somewhat” worried about medical costs in the coming year, and the top concern (31 percent) is their out-of-pocket costs.