Tag: "Pharmaceuticals"

To Control Drug Prices, Pursue Fraud, Not Manufacturers

prescription-bottle(A version of this Health Alert appeared in the Orange County Register.)

A Los Angeles-based nonprofit has gathered enough signatures to get two initiatives on the November statewide ballot. The one of greater interest to ordinary Californians would legislate that any prescription drug paid for with state money cost no more than the amount paid by the Veterans Administration. The California Drug Price Relief Act would have little, if any, short-term effect. There is a better way to control Medi-Cal’s escalating costs.

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What is Driving Health Prices Up?

The recent arrest of Martin Shkreli, former CEO of Turing Pharmaceuticals, for securities fraud, reminds us that high prescription drug prices are today’s whipping boy for the costs of health care. Hillary Clinton and other politicians have promised to impose federal controls on pharmaceutical prices.

However, prescription drugs have not been the fastest growing item in health care since the economy started to enter the Great Recession in 2007. That distinction belongs to health insurance (specifically, medical and hospital insurance, not workers’ compensation, income replacement, or long-term care). Table I shows price indices for various components of personal consumption expenditures, indexed such that 2007 equals 100.

PCE

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Trans-Pacific Partnership Deal Undercuts Biological Invention

vaccine-shot(A version of this Health Alert was published by the Washington Examiner.)

“For want of a nail the shoe was lost; for want of a shoe the horse was lost; for want of a horse the battle was lost; for the failure of battle the kingdom was lost — All for the want of a horse-shoe nail.”

That proverb reflects what could be the fate of the Trans-Pacific Partnership, the multilateral trade agreement the United States and 11 other Pacific Rim countries recently signed after seven years of negotiation. What all of the countries have in common is a commitment to overcome domestic political obstacles to expanding free trade. Unfortunately, what U.S. negotiators appear to have agreed to in October is a final draft that might not pass Congress.

An important part of the deal is protection of intellectual property — including copyright, trademarks and patents — which are necessary for commercial and scientific innovation. The biggest obstacle to congressional approval, however, appears to be the deal’s inadequate protection of intellectual property in “biologic” medicines.

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Hillary Clinton Profits from Big Pharma, Big Insurance

Chris Jacobs of the Conservative Review has an interesting review of Hillary Clinton’s business income from health insurers and pharmaceutical manufacturers:

At the end of this campaign’s first debate for Democratic presidential candidates, Hillary Clinton claimed that she counted the pharmaceutical and insurance industries as her enemies. Since that time, various reports have focused on the way in which her campaigns, as well as the Clinton Foundation, have profited from contributions by drug and insurance companies. However, few have reported how Bill and Hillary Clinton personally profited from insurance and drug company largesse.

To call it mere profit would be an understatement. As the below spreadsheet shows, financial disclosure records filed by the Clintons demonstrate that since Bill Clinton left office in January 2001, he and his wife have received more than $9.3 million in honoraria for speeches before groups associated with health care, and a whopping $3.4 million for speeches paid for by groups in the drug, device, and insurance industries (bolded in the spreadsheet).

(Readers can download the spreadsheet at Mr. Jacob’s article.)

My own conclusion is that the health insurers will get what they paid for, if Mrs. Clinton is elected President, whereas the drug-makers will be reminded of the old adage that “you cannot buy politicians; but only rent them.”

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Hillary Clinton Wrong on Prescription Drugs

Hillary(A version of this Health Alert was published by the Washington Examiner.)

With perfect timing, Hillary Clinton’s presidential campaign announced a proposal to impose federal price controls on prescription drugs the day after Turing Pharmaceuticals declared it was raising the price of Daraprim, a medicine to combat the “toxoplasmosis” parasite, from $13.50 to $750 per pill.

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Martin Shkreli A Creature of FDA Regulation, Not Pharma Industry’s Greed

HSA(A version of this Health Alert was published by Forbes.)

Perhaps it is just unfortunate coincidence, but Hillary Clinton’s proposal to impose federal controls on prescription drug prices was perfectly timed to ride the public outrage over a hedge-fund manager turned pharmaceutical executive, Martin Shkreli, who raised the price of a  decades-old drug drug from $13.50 per pill to $750.

Mrs. Clinton lumps all nominally expensive prescription drugs into the same category of so-called “specialty drugs.” However there is a world of difference between Mr. Shkreli’s Daraprim and specialty drugs like Sovaldi and Harvoni. The latter are newly invented medicines that required many years and huge amounts of capital investment to achieve therapeutic advances for patients suffering Hepatitis C that radically increase their quality of life. They comprise intellectual property protected by patents, which allow the drug makers to compete without fear that their innovations will be copied immediately by manufacturers who made no comparable investment in R&D.

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Hillary’s Tweet Crushes Hopes and Dreams

Hillary Clinton has tweeted a teaser for her forthcoming proposal to lower prescription drug prices. Here it is:

HRC Tweet

This short tweet immediately hit biotech stocks, according to Bloomberg:

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Cross-Over Investors Key Players in Health Deal Boom

SVB

(A version of this Health Alert was published by Forbes.)

Silicon Valley Bank has published its mid-year report on the state of financing in biotech, medical devices, and diagnostics. The key take-away is that both private financing and exits continue to be strong. One development in the structure of the market that has made deals easier to move through the pipeline is the rise of cross-over investors. These are mutual funds or hedge funds (usually investors in listed securities) which are increasingly investing in private health deals.

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British National Health Service Stops Paying for Lifesaving Drugs

Variety of Medicine in Pill BottlesBritain’s government-monopoly (single-payer) health plan, the National Health Service (NHS) has announced plans to stop paying for the most innovative, lifesaving drugs:

More than 5,000 cancer patients will be denied life-extending drugs under plans which charities say are a “dreadful” step backwards for the NHS.

Health officials have just announced sweeping restrictions on treatment, which will mean patients with breast, bowel, skin and pancreatic cancer will no longer be able to receive drugs funded by the NHS.

In total, 17 cancer drugs for 25 different indications will no longer be paid for in future.

Charities said the direction the health service was heading in could set progress back by centuries.

The Cancer Drugs Fund was launched in 2011, following a manifesto pledge by David Cameron, who said patients should no longer be denied drugs on cost grounds.

Drugs which will no longer be funded include Kadcyla for advanced breast cancer, Avastin for many bowel and breast cancer patients, Revlimid and Imnovid for multiple myeloma, and Abraxane, the first treatment for pancreatic cancer in 17 years.

(Laura Donnelly, “Thousands of Cancer Patients to be Denied Treatment,” The Telegraph, September 4, 2015)

This is the second round of cuts this year. All in all, reimbursement for 25 drugs used by about 8,000 patients has been cut off. Unfortunately, this is not surprising.

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Victory for Free Speech in Medicine

Variety of Medicine in Pill BottlesJudges are chipping away at government censorship of communications about prescription drugs. The Food and Drug Administration exerts great power over a medicine’s label, which describes the medicine’s therapeutic claims. Drug makers and the FDA sometimes spend years negotiating a label.

The FDA regulates both safety and “efficacy.” So, a drug maker has to prove its medicine works to the FDA before marketing it to doctors. However, the cost of clinical trials to prove claims is monumentally high, so drug makers will not always invest in clinical trials for every indication. Once a drug is used, doctors will find that it is effective for more claims than indicated on the label. The new indications are often supported by peer-reviewed, published research. However, the drug makers have not yet invested the time and money to negotiate with the FDA to get the new claims onto the label. The FDA says drug makers can’t talk about these off-label uses. A federal judge just decided they can.

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