USA - FDA - Pharmaceutical Products: Eye drops recalled by FDA from Walmart and Walgreens

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https://chicago.suntimes.com/consumer-affairs/2019/7/7/20685310/eye-drops-recalled-walmart-walgreens-fda

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EU-US Relations: Trump Tariffs: EU to respond to any U.S. auto tariff move: by Mathieu Rosemain

The European Union will respond to any U.S. move to raise tariffs on cars made in the bloc, a senior European Commission official said, the latest comments in an escalating trade row.

U.S. President Donald Trump on Friday threatened to impose a 20 percent tariff on all imports of EU-assembled cars, a month after his administration launched an investigation into whether auto imports posed a national security threat.

“If they decide to raise their import tariffs, we’ll have no choice, again, but to react,” EU Commission Vice President Jyrki Katainen told French newspaper Le Monde.

“We don’t want to fight (over trade) in public via Twitter. We should end the escalation,” he said in the comments published on Saturday.

Trump told carmakers at a meeting in the White House on May 11 that he was planning to impose tariffs of 20 or 25 percent on some imported vehicles and sharply criticized Germany’s automotive trade surplus with the United States.

Note EU-Digest: Come on EU Commission, take your gloves off, and hit Trump where it hurts: medical equipment and supplies, weapons industry, NATO.

Read more: EU to respond to any U.S. auto tariff move: report | Reuters

Health Insurance:US Medical Care in Shambles - Europe and other countries have far better cost controls than US

US Health Care in shambles

 1. The United States, unlike many developed nations, does not have aggressive government-monitored cost-control regimes in providing healthcare.

2. This applies especially to the 49% of Americans who are insured via private employer-based healthcare plans
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3. The U.S. government does not use its demand-side/purchasing power to negotiate national prescription drug prices on behalf of consumers.

4. There is also no U.S. prohibition on TV advertising for drugs, unlike every other country in the world except New Zealand.

5. As a result, U.S. drug prices are often one-third higher, if not double and beyond, than in countries such as Canada, Germany, Turkey, The Netherlands or Australia.

6. Medicare, the U.S. single-payer public insurance system for seniors and the disabled, covering about 13% of the U.S. population, also has a largely non-negotiated pricing system that has been criticized for lack of transparency and inflated pricing.

7. Countries such as Germany manage to keep annual increases in health insurance costs limited, in contrast to the average increase of 5% registered in the United States over the past 10 years.

8. The 2010 U.S. health reform law included some (mild) new cost-control provisions. Private insurers must spend 80% of money gathered from premiums on providing actual healthcare services, rather than on overhead, marketing and executive compensation.

9. A proposal for a publicly-run health plan to provide market competition as a cost control method did not make it into the final 2010 law.

10. In 2012, the health sector spent about $270 million on Political campaign contributions and other campaign activities in the United States. The insurance sector spent tens of millions, too

11. The United States spends 16.4% of its national GDP – or $2.75 trillion – each year on healthcare costs (as of 2013).

12. Healthcare consumes a far greater share of national GDP in the United States than in any other OECD country – at least 50% more than in other comparable countries.

13. In Germany, healthcare consumed 11% of GDP in 2013. France spent 10.9% of GDP on it.


Where Are the Cost Controls? - The Globalist

Health: Study shows: Cancer is not just down to 'bad luck' - by Holly Ellyatt

Cancer is mostly a result of external, environmental risk factors rather than down to "bad luck," according to a new study published in Nature magazine, which challenges prominent research into the causes of cancer.

Research into the causes of the disease have prompted clashes between scientists in recent months, with one study published in the journal Science earlier this year suggesting that two thirds of cancers were caused by chance – just plain old "bad luck," the study said -- rather than environmental factors or inherited predispositions.

The study was controversial as it implied that cancer, put down to the malignant transformation of cells that multiply within the body, was largely unavoidable and that it came down to the number of times a cell divides (giving rise to the "bad luck" conclusion).

The latest study on cancer development in Nature challenged the "bad luck" hypothesis, however, concluding that cancer risk is "heavily influenced by extrinsic factors" with only 10-30 percent of cancers down to intrinsic risk factors such as mutations.

The study was conducted by a team of doctors, including Song Wu, Scott Powers, Wei Zhu and led by Yusuf Hannun, at Stony Brook University in New York.


They found that there was a "substantial contribution of external risk factors to cancer development" including environmental factors like ultraviolet (UV) radiation and carcinogens, such as smoking.

Summarizing their findings, they said the results were important for "strategizing cancer prevention, research and public health."

Both studies come at a time of increased spending on cancer treatments by national health bodies and drug research by pharmaceutical companies.

Total global spending on cancer medications reached the $100 billion threshold in 2014, according to a report by the U.S.-based IMS Institute for healthcare informatics released in May.

Growth in global spending on cancer drugs – measured using ex-manufacturer prices and not reflecting off-invoice discounts, rebates or patient access programs – increased at a compound annual growth rate of 6.5 percent on a constant-dollar basis during the past five years," the institute said in the report.

Spending on oncology - the study and treatment of cancers and tumors - remains concentrated among the U.S. and five largest European countries, which together account for 66 percent of the total market, it added.
Pharmaceutical companies are keen not to miss out on increased spending. U.K. pharmaceutical giant AstraZeneca announced on Thursday that it was to bolster its blood cancer treatment portfolio by buying a 55 percent stake in Acerta Pharma in a deal valued at $4 billion dollars.

Read more: Cancer is not just down to 'bad luck': Study

Drugs and Medicine Costs: Doctors Say Cancer Drug Prices Unaffordable by Diane Archer

Last month, in an article for Mayo Clinic Proceedings, a group of 118 distinguished doctors united to question the pricing of cancer drugs, which is "unsustainable," and to call for a new pricing method. As this 60 Minutes report reveals, the drug companies set the price of cancer drugs as high as they can. And because of their market power, cancer drug prices have risen an average of $8,500 a year for the last 15 years, a five to ten-fold increase in the price of new cancer drugs over that period.

One in three Americans will have some form of cancer. And, even with insurance, they typically will end up bearing 20 to 30 percent of the cost of their cancer drugs. Insurers have no ability to rein in prices so insurers simply shift more drug costs to their members.  People who need a new cancer drug easily could end up with out-of-pocket annual costs of $30,000 just for their cancer medication. Worse still, they might have to forego needed treatment. In 2014, the least expensive new cancer drug approved cost more than $120,000 a year.

American households have an average gross income of $52,000. And half of people over 65 have incomes under $23,500. Most Americans will need to sell assets or take out loans to pay for the drugs.

Not surprisingly, as many as one in five cancer patients today are not taking their cancer treatments or taking less than the amount they need. They and their families are suffering and some are needlessly dying. The doctors argue that something has to change.

The doctors offer several possible solutions, including Medicare drug price negotiation, which is the top policy priority for Americans. They also suggest legislation that would prevent pharmaceutical companies from paying generic drug companies to delay putting generic drugs in the market at lower prices and/or that would allow Americans to import drugs from abroad at lower prices. Click here to read their other proposed solutions.

Read more: Doctors Say Cancer Drug Prices Unaffordable | Diane Archer

Pharmaceutical Industry: Do free samples influence the way doctors prescribe drugs?

A new study from Stanford University's School of Medicine found that doctors who are allowed to hand out free samples of expensive drugs prescribe those drugs more often than doctors who don’t have access to free samples. Dr. Alfred Lane, senior author of the report, talks with Hari Sreenivasan about the implications of the findings.

See more: Video: Do free samples influence the way doctors prescribe drugs? | Watch PBS NewsHour Online | PBS Video

Canada-EU trade deal puts profit before the public good - by Paul Most and Maude Barlow

There is little wonder left why the Harper government has been so secretive about the details of its ongoing “trade” negotiations with the European Union. The more we hear and see about the Comprehensive Economic and Trade Agreement (CETA), the less there is to like.

After the recent leak of CETA documents, there is quite a bit to see. In fact, we have a good sense of where the trade-offs lie, and what the municipal and provincial governments will have to give up so Mr. Harper can have his highly imbalanced deal.

According to the leaks, Canada has tied a single issue – market access for agricultural goods like beef and pork – to the EU’s most important demands, including patent extensions for pharmaceuticals (contained in a broader intellectual property chapter), procurement and dairy supply management.

Mr. Harper’s message is clear: let more Canadian meat into your borders and we will give you most of what you want in these other areas. Even if this means more expensive health care, and our municipalities giving up the right to “buy local” when spending public money.

The EU is asking Canada to change its pharmaceutical patent regime to extend protections to brand name drug companies at the expense of generic competition. Delaying generic drugs by even a year or two will have huge financial consequences for our public health care system, and Canadians in need of affordable prescription drugs.

Read more: Canada-EU trade deal puts profit before the public good - The Globe and Mail

New EU regulations on herbal medicines come into force

New European Union rules have come into force banning hundreds of traditional herbal remedies. The EU law aims to protect consumers from possible damaging side-effects of over-the-counter herbal medicines.

For the first time, new regulations will allow only long-established and quality-controlled medicines to be sold.

For more: BBC News - New EU regulations on herbal medicines come into force

Livemint.com: Shipments seizure of Pharmaceuticals: India’s drug makers may avoid EU route - by Lison Joseph

For the complete report from livemint.com click on this link

Shipments seizure of Pharmaceuticals: India’s drug makers may avoid EU route - by Lison Joseph

A new battleground seems to have opened up over shipments of India’s drug exporters meant for Latin America that are being seized in transit by European Union (EU) countries. In the last one month alone, Chandigarh-based Ind-Swift Laboratories Ltd and several other Mumbai-based bulk drug makers—all of them small- and medium-sized firms—have had their shipments seized at EU ports, according to the Pharmaceuticals Export Promotion Council (Pharmexcil), an agency set up by India’s commerce ministry.

“In the last couple of months, we have been receiving an increasing number of reports from pharma exporters about their consignments being seized in European Union countries including Germany, France, the UK and the Netherlands,” said Pharmexcil executive director P.V. Appaji.Munjal and Pharmexcil said the reason EU authorities have given for the seizures was that these drug consignments violated intellectual property rights and were, therefore, counterfeit. Pharmexcil, on its part, says the seized products—meant for largely unregulated Latin American markets—are genuine and legal.

“These are not substandard or in anyway of compromised quality. Besides, they are not meant for the European market but are just using EU ports while in transit to markets in Latin America, where they do not violate any laws,” Appaji claimed.