Fertile ground for Medicaid pitch- The Washington Post

Pharmaceutical corporations need to stop free-riding on publicly-funded research | TheHill

Pharmaceutical corporations need to stop free-riding on publicly-funded research | TheHill: “The White House’s report suggests that it costs an estimated $2.6 billion to develop a new drug today, though they’re basing this on a single, non-transparent pharmaceutical industry-supported study with problematic methodology.

In reality, companies receive substantial publicly-funded support from the government. A recent study found that all 210 drugs approved in the U.S. between 2010 and 2016 benefitted from publicly-funded research, either directly or indirectly.

Taxpayers contribute through public university research, grants, subsidies, and other incentives. This means people are often paying twice for their medicines: through their tax dollars and at the pharmacy.

At Doctors Without Borders/Médecins Sans Frontières (MSF), we see each and every day the human suffering caused in the places we work and many countries outside the U.S. by treatments being rationed or people being denied essential medical care due to high drug and vaccines prices.”

‘via Blog this’

The Role Of Sales Representatives In Driving Physicians’ Off-Label Prescription Habits – Health Affairs Blog

Off-label prescribing is widespread in Canada and the United States. One in nine prescriptions for Canadian adults are for off-label uses with the highest percentages coming from anticonvulsants (66.6 percent), antipsychotics (43.8 percent), and antidepressants (33.4 percent). Overall, 79 percent of the off-label prescriptions lacked strong scientific evidence for their use.

For 160 drugs commonly prescribed to U.S. adults and children, 21 percent were for off-label indications totaling 150 million prescriptions. In this case, 73 percent had little to no scientific backing and once again psychoactive drugs such as gabapentin had the highest level of off-label use.

Moreover, doctors do not seem to know what are and are not approved FDA use for many of the drugs that they prescribe. Now an article published in the June issue of Health Affairs by Ian Larkin and colleagues points to active promotion by sales representatives as one reason for the widespread off-label use of antipsychotics and antidepressants in children.

The Role Of Sales Representatives In Driving Physicians’ Off-Label Prescription Habits – Health Affairs Blog

The Myth of the Medical-Device Tax – NYTimes.com

Not only can the medical-device industry easily afford the tax without compromising innovation, but the industry’s enormous profits are a result of anticompetitive practices that themselves drive up medical-device costs unnecessarily. The tax is a distraction from reforms to the industry that are urgently needed to lower health care costs.

The medical-device industry faces virtually no price competition. Because of confidentiality agreements that manufacturers require hospitals to sign, the prices of the devices are cloaked in secrecy. This lack of transparency impedes hospitals from sharing price information and thus knowing whether they are getting a good deal.

Even worse, manufacturers often maintain personal relationships (sometimes involving financial payments like consulting fees) with physicians who choose the medical devices that their hospitals purchase, creating a conflict of interest. Physicians often don’t even know the costs of the devices, and individual physicians often choose devices on their own, which weakens a hospital’s ability to bargain for volume discounts.

Such anticompetitive practices help generate a wide variation in the prices of medical devices — and contribute to higher prices in general. For example, the Government Accountability Office found that prices for cardiac implantable medical devices in the United States vary by several thousand dollars. And even the lowest-priced devices in the United States are expensive compared with those in other developed countries. According to the consulting firm McKinsey & Company, the United States spends about 50 percent more than expected on the top five medical devices, compared with Europe and Japan. McKinsey calculates that this amounts to $26 billion in excessive spending each year. Medicare, private health insurers and patients end up paying these inflated prices.

Excessive prices fuel enormous profits — profits that dwarf both the medical-device tax and the industry’s investments in research and development. Consider the device division of Johnson & Johnson, which in 2012 had an operating profit of $7.2 billion. By the company’s own estimate, the device tax would amount to at most $300 million, and its investment in research and development amounts to only $1.7 billion.

The Myth of the Medical-Device Tax – NYTimes.com

Excise Tax on Medical Devices Should Not Be Repealed — Center on Budget and Policy Priorities

By Paul N. Van de Water

Updated May 31, 2012

The House will soon consider legislation to repeal the excise tax on medical devices that was enacted to help pay for health reform. The provision is sound, however, and the industry lobbying campaign aimed at repealing it is based on misinformation and exaggeration.

The medical device industry is not being singled out. The excise tax is one of several new levies on sectors that will gain business due to health reform. The expansion of health coverage will increase the demand for medical devices and could offset the effect of the tax.

The tax will not cause manufacturers to shift production overseas. The tax applies equally to imported and domestically produced devices, and devices produced in the United States for export are tax-exempt.

The tax will have little effect on innovation in the medical device industry. To the contrary, health reform may well spur medical device innovation by promoting more cost-effective ways of delivering care.

The Joint Committee on Taxation estimates that repealing the excise tax would cost $29 billion over the 2013-2022 period.[1] Repealing the tax would undercut health reform in at least two ways. Pay-as-you-go procedures would require Congress to offset the cost of repeal by increasing other taxes or reducing spending; one likely target would be the provisions of the Affordable Care Act (ACA) that expand health coverage to 33 million more Americans. Also, repealing the tax would encourage efforts to repeal other revenue-raising provisions of the ACA, which in turn would either require still more painful offsets or increase the budget deficit (if Congress failed to offset the cost).

Excise Tax on Medical Devices Should Not Be Repealed — Center on Budget and Policy Priorities

Bill Moyers: Foul Play in the Senate

The Times story described how Amgen got a huge hidden gift from unnamed members of Congress and their staffers. They slipped an eleventh hour loophole into the New Year’s Eve deal that kept the government from going over the fiscal cliff. When the sun rose in the morning, there it was, a richly embroidered loophole for Amgen that will cost taxpayers a cool half a billion dollars.

Amgen is the world’s largest biotechnology firm, a drug maker that sells a variety of medications. The little clause secretly sneaked into the fiscal cliff bill gives the company two more years of relief from Medicare cost controls for certain drugs used by patients who are on kidney dialysis, including a pill called Sensipar, manufactured by Amgen.

The provision didn’t mention Amgen by name, but according to reporters Lipton and Sack, the news that it had been tucked into the fiscal cliff deal “was so welcome, that the company’s chief executive quickly relayed it to investment analysts.” Tipping them off, it would seem, to a jackpot in the making.

Amgen has 74 lobbyists on its team in Washington and lobbied hard for that loophole, currying favor with friends at the White House and on Capitol Hill. The Times reporters traced its “deep financial and political ties” to Baucus, McConnell and Hatch, “who hold heavy sway over Medicare payment policy.”

All three have received hefty campaign donations from the company whose bottom line mysteriously just got padded at taxpayer expense. Since 2007, Amgen employees and its political action committee have contributed nearly $68,000 to Senator Baucus, $73,000 to Senator McConnell’s campaigns, and $59,000 to Senator Hatch.

And lo and behold, among those 74 Amgen lobbyists are the former chief of staff to Senator Baucus and the former chief of staff to Senator McConnell. You get the picture: Two guys nurtured at public expense, paid as public servants, disappear through the gold-plated revolving door of Congress and presto, return as money changers in the temple of crony capitalism.

What if Medicare’s drug benefit was more like the VA’s? | The Incidental Economist

Medicare’s inability to negotiate program-wide prices and tighten plan formularies is in stark contrast to the VA, which negotiates directly with drug manufacturers and is not bound by the same formulary rules as Part D plans. That’s why the VA has been able to implement a national formulary more restrictive than those of Medicare plans and obtains lower drug prices. If Medicare plans could implement VA-like formularies and obtain commensurately lower prices, our paper shows that enough could be saved to compensate beneficiaries for the loss of choice, with savings to spare.

To repeat, the key findings are:

The VA pays 40% less than Medicare plans for prescription drugs.
Medicare plans cover about 85% of the most popular 200 drugs on average (ranging from a low of 68% to a high of 93%).
The VA’s national formulary includes 59% of the most popular 200 drugs.
If Medicare obtained the same drug prices as the VA, it would save $510 per beneficiary per year or a total of $14 billion per year (2009 prices).
If Medicare plans tightened formularies to the level of generosity available from the VA (59% of top 200 drugs covered), beneficiaries would lose $405 of value per year associated with the loss of choice of drugs. (The right way to interpret this is that the average beneficiary would be precisely indifferent between the loss of drug choice and $405 dollars in cash.)
Because the savings ($510 per beneficiary) exceeds the loss of value to beneficiaries ($405), they could, in principle, be made whole with $105 left over (= $510 – $405).

“Transparency Reports” on Industry Payments to Physicians and Teaching Hospitals – — JAMA

“Transparency Reports” on Industry Payments to Physicians and Teaching Hospitals – — JAMA:

Thanks, again, Affordable Care Act…

Public awareness of industry payments to physicians and teaching hospitals in the United States is about to markedly increase. As required by the “Sunshine” provisions of the Patient Protection and Affordable Care Act, by September 2013 the Centers for Medicare & Medicaid Services (CMS) is to publish “transparency reports” that disclose these industry payments on a public website; the information must be “searchable,” “clear and understandable,” and “able to be easily aggregated and downloaded.”1 Unlike most disclosures of physician-industry relationships to date, the reports will include the amounts of payments or other “transfers of value.” Payments large and small should be revealed, including the drug or device that the payment was related to.

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Despite the hype, some new drugs aren’t effective for patients – Healthy Living

Despite the hype, some new drugs aren’t effective for patients – Healthy Living:

For years, I frustrated the Tekturna representative who came to my office. I refused to write even one prescription. Our conversations each week were identical. I would argue that there are generic high blood pressure medicines that are cheaper and just as effective, but much more importantly, I would argue that Tekturna did not have any proof that it was truly beneficial.

To this claim, the representative was astounded that I did not agree with the glossy graphs that showed how much blood pressures were lowered for people on the drug. For me and my patients, though, lowering blood pressure is not nearly enough; we need to know that the drug protects against the problems, such as strokes, that are linked to high blood pressure.

Despite showing that Tekturna lowered blood pressures, no research trial ever documented that it reduces the risk of heart disease, stroke and death.

We treat high blood pressure to reduce the risk for heart attacks and strokes. Period. Lowering the numbers we see on the blood pressure cuff is nice, but stopping a stroke is what counts.

Dozens of generic blood pressure medicines reduce the risk of stroke, heart attack and death, but Tekturna had no such research evidence.

A FULLER PICTURE

In the past, there have been many instances of drugs that move numbers (like blood pressure), but that can worsen clinical outcomes. Alpha-blockers, for example, were shown decades ago to cause increased numbers of deaths in heart failure patients despite powerfully lowering blood pressures.

Last month, a clinical trial of Tekturna (the ALTITUDE trial) was stopped before it was completed. In trying to measure if Tekturna reduced the risk for heart attack and stroke, researchers discovered that Tekturna significantly increased the risk of stroke, kidney complications and problems with blood potassium levels.

The drug actually caused patients harm in comparison with generic alternatives, so the manufacturer recently stopped marketing it.

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Anti-Open Access Rises Again | The Scientist

Anti-Open Access Rises Again | The Scientist:

US Representatives Darrel Issa (R-CA) and Carolyn Maloney (D-NY) introduced a bill into the House of Representatives in mid-December that would roll back the National Institutes of Health Public Access Policy, which mandates that any published research that was funded by the federal science agency be submitted to the publically accessible digital archive PubMed Central upon acceptance for publication in journals. The bill, H.R. 3699, would also make it illegal for other federal agencies to adopt similar open-access policies.

Making your tax dollars go farther?

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Like it or not, Obamacare forces drug company disclosure – News – ReviewJournal.com

Like it or not, Obamacare forces drug company disclosure – News – ReviewJournal.com:

The New York Times and the Wall Street Journal have taken the lead in writing about potential conflicts of interest between doctors and medical manufacturers. Although philosophically on opposite sides, both newspapers have raised questions in chilling stories about doctors taking money from drug and device manufacturers.

The Times’ reported that some doctors practice medicine differently if they take money and are more willing to prescribe drugs in risky and unapproved ways.

In the regulations being finalized, executives at the top would be responsible for the accuracy for that disclosure. The information would be on a searchable website so the public can check it out. About 1,100 companies would have to file reports.

Every transaction may not be dubious, but when more than one out of four doctors are paid for consulting, lectures or enrolling patients in clinical trials, you deserve to know if your doctor might have a financial interest in a particular company.

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