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Pharmaceuticals can be a license to print money

By Pete Dolack | Systemic Disorder | October 11, 2107

It’s no secret that the United States suffers from by far the world’s highest costs for health care. As the most market-oriented health care system among advanced capitalist countries, this is no surprise. Health care in the U.S. is designed to deliver corporate profits, not health care.

On that score, the U.S. system is quite successful. Pharmaceutical companies are at the head of the class in this regard, frequently justifying the spiraling costs of medications by citing large research and development costs that include the costs for drugs that don’t make it to market. There are many drugs that fail to survive testing and become a cost that will never be compensated, that is true. But are these failures really so high to justify the extreme costs of successful drugs?

It would seem not. Firmer proof of that lack of justification has been published by the JAMA Internal Medicine journal, which found that revenue for cancer drugs far outstrips spending on research and development. The article, “Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval,” prepared by Drs. Vinay Prasad and Sham Mailankody, found that revenue from 10 drugs (one by each of 10 companies) exceed those companies’ total research and development costs by more than seven times.

The total revenue hauled in from these 10 drugs did vary considerably. Two of them earned more than US$20 billion after approval. Both of these high performers cost less than $500 million in research and development costs. The revenue from each of the 10, however, exceeded costs, with widely varied margins. Still profitable: The median revenue of these 10 drugs was $1.7 billion, more than double the median development cost of $648 million, the JAMA Internal Medicine authors report.

The authors write that the median cost to develop a cancer drug represents “a figure significantly lower than prior estimates,” adding that their analysis “provides a transparent estimate of R&D spending on cancer drugs and has implications for the current debate on drug pricing.”

To obtain these figures, the authors analyzed U.S. Securities and Exchange Commissions filings for pharmaceutical companies with no drugs on the U.S. market that received approval by the U.S. Food and Drug Administration for a cancer drug from January 1, 2006, through December 31, 2015. Cumulative R&D spending was estimated from initiation of drug development activity to date of approval. Earnings were tracked from the time of approval to March 2017.

The sky’s the limit for pharmaceutical prices

The increase in pharmaceutical prices (blue) versus the general increase in commodities prices (red).

Another way of looking at this would be to examine the increases in the cost of pharmaceuticals against other products. Here again the numbers stand out. Using data gathered by the St. Louis branch of the Federal Reserve Bank, the consumer price index for pharmaceutical preparation manufacturing for the first quarter of 2017 was 747.8, with January 1, 1980, as the benchmark of 100. In other words, the price of pharmaceuticals is seven and half times higher than they were at the start of 1980. (See graph above.)

How does that compare with inflation or other products? Quite well — for pharmaceutical companies. That more than sevenfold increase in drug prices is an increase nearly two and half times greater than inflation for the period, and nearly four times that of all commodities.

So, yes, unconscionable price-gouging is the cause here. By the industry as a whole, not simply individuals like “Pharma Bro” Martin Shkreli, who might be an outlier in his brazenness but not in his profit-generation plan.

Although not the entire picture, this snapshot of corporate extortion plays a significant role in why the cost of the United States not having a universal health care system is more than $1.4 trillion per year.

Among 19 broadly defined “major” industrial sectors in the U.S., health technology is again expected to be found the most profitable for 2016, with a profit margin of 21.6 percent. Higher even than finance at 17 percent. When narrowing to more specific, narrowly defined industry categories, generic pharmaceuticals sit at the top with an expected 30 percent profit margin for 2016. Major pharmaceuticals rank fourth at 25.5 percent on a list in which health products and finance claim nine of the top 10 spots.

The sky’s the limit for pharmaceutical profits

That’s a repeat of 2015, when health technology had the highest profit margin of 19 broadly defined industrial sectors, at 20.9 percent, topping even finance, the second highest. When a separate study broke down profit margins by more specific industry categories, health care-related industries comprised three of the six most profitable.

Nothing new there, either. A BBC report found that pharmaceuticals and banks tied for the highest average profit margin in 2013, with five pharmaceutical companies enjoying a profit margin of 20 percent or more — Pfizer, Hoffmann-La Roche, AbbVie, GlaxoSmithKline and Eli Lilly. The world’s 10 largest pharmaceutical corporations racked up a composite US$90 billion in profits for 2013, according to the BBC analysis. As to their expenses, these 10 firms spent far more on sales and marketing than they did on research and development.

If those facts and figures aren’t enough, here’s another way of looking at excessive profits — a 2015 study found that, of the 10 corporations that have the highest revenue per employee among the world’s biggest corporations, three are health care companies. Two of the three, Amerisourcebergen and McKesson, both distribute pharmaceuticals, and the other, Express Scrips, administers prescription drug benefits for tens of millions of health-plan members. Each of these primarily operates in the United States, the only advanced-capitalist country without universal health coverage.

The extra layers represented by those three companies demonstrate that there are ample opportunities for corporate profiteering that contribute to extraordinarily high health care costs in the U.S., beyond drug manufacturing and insurance.

And because corporations have the ear of politicians and other government officials, it’s no surprise that one of the primary ongoing goals of the U.S. government for so-called “free trade” agreements, such as the Trans-Pacific Partnership, is to impose rules that would weaken the national health care systems of other countries. This was done in TPP negotiations at the direct behest of U.S.-based pharmaceutical companies, incensed that countries like New Zealand make thousands of medicines, medical devices and related products available at subsidized costs.

By far the most expensive system while delivering among the worst outcomes and leaving tens of millions uninsured, where tens of thousands die from lack of health care annually. That is the high cost of private profit in health care. Or, to put it more bluntly, allowing the “market” to decide health outcomes instead of health care professionals.

October 15, 2017 Posted by | Corruption, Deception, Economics, Malthusian Ideology, Phony Scarcity | , , , , , | 2 Comments

Suppressed Memo: Eli Lilly Hid Increase in Suicidal Thoughts and Aggression with Prozac for Years

By Aaron and Melissa Dykes | Truthstream Media | October 27, 2015

It would seem that every time there is a mass shooting in this country, the shooter has either been taking psychotropic medications, usually in the form of antidepressants, or the shooter has recently quit taking antidepressants.

It is well known that these medications can cause suicidal thoughts, especially in young people up to around age 24. If a medicine can cause suicidal thoughts, it would only follow that it can possibly cause violent or homicidal thoughts as well.

A multitude of studies have linked antidepressants to everything from birth defects (including a very serious birth defect called persistent pulmonary hypertension of the newborn, causing the Food and Drug Administration to place a black box warning on them) to increased suicidal tendencies (causing the FDA to update the initial black box warning to include an additional suicidal tendencies warning).

Eli Lilly, the pharmaceutical giant that brought us Prozac, knew this from its own trials as far back as 1984, but the company kept it from the public and the FDA for years, long after the drug was approved in 1988. This information only came to light through a highly controversial litigation.

What do these documents, which the company reportedly worked to keep hidden, reveal about the potential dangers of Prozac (fluoxetine)?

The “confidential” report opens by stating that:

“Fluoxetine [Prozac] may produce both activation (nervousness, anxiety, agitation, insomnia) and sedation (somnolence, asthenia). Approximately 19% of patients might be expected to report activation during acute therapy with fluoxetine which was not present prior to therapy and which could be attributed to fluoxetine (in trials, 38% fluoxetine-treated patients reported new activation but 19% of placebo-treated patients also reported new activation yielding a difference of 19% attributable to fluoxetine).”

It is worth noting, however, that the control used in trials was apparently also a psychotropic drug, trazodone, a serotonin antagonist reuptake inhibitor (SARI) that carries “activation” risks of its own, including suicidal and violent behavior. Therefore, the true effects may have been downplayed through semantics and parameters set by the study.

At any rate, Lilly’s own internal report on clinical trials matches up incidence reports for fluoxetine against trazodone (an SARI), amitriptyline and desipramine (both tricyclic antidepressants), as well as maprotiline (a tetracyclic antidepressant). It shows a dramatically higher rate of suicide attempts, psychotic depression, hostility and intentional injury for fluoxetine-based Prozac than any of the other antidepressants used in the company’s own trials.

While suicide attempts represented 3.7% of total reports for fluoxetine in trials, it accounted for only 0.2% of the incidents in trazodone, 0.8% in amitryptyline, 0.3% in desipramine and 0.0% for maprotiline. While Lilly attempted to explain away six of the 12 suicide attempts which occurred during its trials of Prozac, but even if you buy their maneuvering, that’s still a 6:1 ratio of suicides potentially induced by Prozac verses controls.

Similarly, psychotic depression reports spiked in fluoxtine at 2.3% while they represented <1% in the other drugs; fluoxetine was two-and-a-half to four times more likely to cause hostility than other drugs tested, and at least eight times more likely to trigger episodes of intentional injury.

fluoxetine-suicide-attempts

Those results show enough risk and red flags it should give any doctor pause before prescribing them to anyone. The 1984 memo even describes ways to explain these findings away to doctors, stating, “Several suggestions may be helpful in presenting this information to physicians” including emphasis on positives like lower discontinuation rates and encouraging physicians to understand “the meaningfulness of subtracting the placebo rate from the drug associated rate” to “point out these values are relatively low”. (Does history show that, just by the way? Obviously not.)

However, with these studies suppressed, Prozac became the “star drug” for depression and Eli Lilly’s blockbuster.

But at what cost, not only to patients, but to legal protections and a right-to-know for the general public, many of whom may be taking, or could be prescribed Prozac?

According to his report on the documents, Dr. Peter R. Breggin, M.D. was responsible for uncovering several concealed internal Lilly memos during the discovery process as a scientific expert in litigation in the early 1990s – and Lilly certainly did not want them to come to light.

Dr. Breggin explains the bizarre and utterly concerning case this way:

I am familiar with these documents because I initially found them in the early 1990s while searching through mountains of paper produced by the drug company in the discovery process. At the time I was the scientific expert for the combined Prozac suits and one of my tasks was to evaluate Eli Lilly’s discovery materials for all the initial cases…

[…]

Paul Smith, the attorney for the plaintiffs, secretly settled the case during the trial and then denied the fact to presiding Judge John W. Potter. The plaintiffs agreed to water down their presentation of the case to the jury in return for a large secret settlement. After Eli Lilly seemed to win the trial by a 9-3 vote, Judge Potter found out that the trial was a sham aimed at exonerating the drug company.

The Supreme Court of Kentucky declared that Eli Lilly may have committed “fraud” and that the drug company had “manipulated” the judicial system. The judge voided the jury verdict and changed it to “settled with prejudice” by Eli Lilly. Although the initial “victory” by Eli Lilly was widely covered in the press, the change in the verdict was largely ignored.

Consumer protection and medical malpractice hangs in the balance of a very determined legal and marketing team in the modern day world of Big Pharma corporate dominance.

The Indianapolis Star, based in the hometown of Eli Lilly, reported on the legal cunning of the Prozac makers in deflecting liability through “secret deals” and “hardball tactics”:

Critics charge Lilly became adept at lawsuit-quashing through aggressive and sometimes unethical legal tactics. They earned the rebuke of three courts, spurred at least three separate lawsuits and gave rise to charges of trial-fixing, conspiracy and document-hiding.

[…]

The deal was “arguably unprecedented in a Western court,” wrote Cornwell.

Zitrin views the deal as an attempt by Lilly to “create a situation where the trial was fixed.” The deal required Smith to withhold key negative evidence about Lilly from the jury in the end stage of the trial. [Editor’s Note: And also required no appeals or punitive damages.]

The evidence concerned Lilly’s 1985 guilty plea to 25 criminal counts for failing to tell the U.S. Food and Drug Administration about deaths and illnesses of patients taking a Lilly arthritis drug called Oraflex, plus related charges. [Editor’s Note: Analysts say Lilly barely obtained a victory]

[…]

“Lilly made the verdict the centerpiece of a national publicity campaign, touting the safety of Prozac,” said a 1997 ruling by the 7th U.S. Circuit Court of Appeals.

Wow. That is spin at work.

If the reports are true, then a liability in the way of secret deals, suppressed evidence and proof of harm was cleverly turned around into a promotional “victory” for Eli Lilly that dispelled the notions that the drug was harmful or unsafe.

Lilly knew from its own drug trials that nearly 1-in-5 patients would, statistically, undergo “activation”… and could be at risk for a significant increase in suicidal tendencies, as well as aggression and hostilities that were not otherwise expressed.

Reports show that 12 people attempted suicide during Lilly’s own trials, way more than with the other drugs tested, and even with half of these somehow explained away by other factors in the study, the warning would have been apparent if the information had been made available to the FDA and the public.

Read the PDF for yourself.

Instead, profits were put ahead of public health concerns, and many consequences – including shattered lives and even mass shooting incidents – have arguably been connected to this ethical failure to put patients and drug safety first.

Today, the US is a Prozac Nation, where more than one in ten people are taking antidepressants. A new study just came out which found that over 2/3rds of people taking drugs like Prozac aren’t even clinically depressed.

Guess it makes for a much more manageable public.

On an interesting side note, kind of makes you wonder why exactly George H. W. Bush became director of the CIA the year after its MK Ultra mind control scandal broke, only to join the board of directors of, you guessed it, Eli Lilly (also involved in MK Ultra) for two years while Prozac was being developed…

October 28, 2015 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , , | 1 Comment

TPP: Big Pharma’s Big Deal

By Joyce Nelson | CounterPunch | October 7, 2015

We still don’t know all the details of the Trans-Pacific Partnership (TPP) trade deal tentatively agreed to on Oct. 5 by negotiators from 12 Pacific Rim countries, but already critics are slamming it for many reasons, including its generous concessions to the pharmaceutical industry.

Doctors Without Borders claims the TPP will “go down in history as the worst trade agreement for access to medicines in developing countries.” [1] That’s because the TPP will extend patent protection for brand-name drugs, thereby preventing similar generic drugs (which are far less costly) from entering the market. This will drive up the prices.

Judit Rius Sanjuan, legal policy adviser for Doctors Without Borders, told vox.com that TPP creates patent-related obligations in countries that never had them before. People in “Peru, Vietnam, Malaysia, and Mexico” will be especially affected, she said. “They’ll face higher prices for longer periods of time.” [2]

Ruth Lopert, a professor at George Washington University, told Bloomberg News that provisions in the TPP agreement will affect health-care budgets and drug access in all signatory countries, but especially the poorest. “She said as many as 40,000 people in Vietnam, the poorest country in the agreement, could stop getting drugs to fight HIV because of provisions that will boost the price of [pharmaceutical] therapy.” [3]

Other countries like Canada will also be hit with higher costs. The Council of Canadians says that if the TPP is ratified, “[p]harmaceutical patents will be extended, delaying the release of more affordable generic drugs and adding $2 billion to our annual public health care bill.” [4] In the U.S., many people already cannot afford to pay for the expensive medicines that could save their lives, and they try to access generics available elsewhere.

Extending patent rights for life-saving drugs is an obvious gift to Big Pharma. Conor J. Lynch at opendemocracy.net has called it “a clear corporate handout that would greatly affect international access and most definitely cause preventable deaths. The clear objective here is to increase industry profits, plain and simple. This is not surprising, that’s what private industry does, but there is a serious moral dilemma here.” [5] That moral dilemma is made even more apparent by recent findings.

Tax Cheats

In an ironic coincidence, the TPP agreement was reached on the same day that a damning report on corporate tax-avoidance – Offshore Shell Games 2015 – was released by Citizens for Tax Justice and the US Public-Interest Research Group Education Fund. The report reveals the extent to which top U.S. companies use tax havens like Bermuda, Luxembourg, Cayman Islands, and the Netherlands to set up “tax haven subsidiaries” that are usually little more than a post-office box.

Of the top 30 Fortune 500 companies with the most money held in offshore tax-havens, nine are pharmaceutical companies: Pfizer ($74 billion held offshore), Merck ($60 billion), Johnson & Johnson ($53.4 billion), Proctor & Gamble ($45 billion), Amgen ($29.3 billion), Eli Lilly ($25.7 billion), Bristol Myers Squibb ($24 billion), AbbeVie Inc. ($23 billion), and Abbott Laboratories ($23 billion). [6]

Concerning Pfizer, the world’s largest drug maker (declared profits of $22 billion in 2013), the report states: “The company made more than 41 percent of its sales in the U.S. between 2008 and 2014, but managed to report no federal taxable income for seven years in a row. This is because Pfizer uses accounting techniques to shift the location of its taxable profits offshore. For example, the company can transfer patents for its drugs to a subsidiary in a low- or no-tax country. Then when the U.S. branch of Pfizer sells the drug in the U.S., it ‘pays’ its own offshore subsidiary high licensing fees that turn domestic profits into on-the-books losses and shifts profit overseas.”

Overall, the study found that the 500 largest U.S. companies hold more than US$2.1 trillion in accumulated profits offshore. “For many companies, increasing profits held offshore does not mean building factories abroad, selling more products to foreign customers, or doing any additional real business activity in other countries,” but simply establishing a PO box.

Some companies use the money supposedly “trapped” offshore as “implied collateral” in order to borrow funds at negligible rates for investing in U.S. assets, paying dividends to shareholders, or repurchasing stock.

Of course, as the report makes clear, “Congress, by failing to take action to end this tax avoidance, forces ordinary Americans to make up the difference. Every dollar in taxes that corporations avoid by using tax havens must be balanced by higher taxes on individuals, cuts to public investments and public services, or increased federal debt.”

The report finds that, through a variety of tax-avoidance measures, an estimated US$620 billion in U.S. taxes is collectively owed by the 500 largest companies with headquarters in the U.S.

Corporate Coup

Now the TransPacific Partnership – which is being called “NAFTA on steroids” – would award Big Pharma and other multinationals even more corporate “rights” in more countries, including the controversial investor-state dispute settlement (ISDS) mechanism by which they can sue signatory governments for regulatory changes that affect their profits.

As the Canadian website rabble.ca notes: “The Canadian government is currently being sued through NAFTA by Eli Lilly, an American pharmaceutical company, for invalidating the firm’s patent extensions on two mental health drugs. A Canadian Federal Court decided in 2010 that the patent extensions had not delivered the promised benefits and the drugs should therefore be opened up to generic competition. Generic drugs significantly reduce the cost for end users, but Eli Lilly cried foul and launched an ISDS claim against the government, demanding US$500 million in compensation for lost profits. The case is still in progress, but regardless of the outcome we can expect the TPP to lead to similar ISDS disputes. Powerful multinational pharmaceutical companies will use any available means to cling to over-priced drug monopolies. Greater intellectual property protections in the TPP will give these companies an even stronger quasi-legal basis to sue governments and crowd out generic [drug] competition.” [7]

The final text of the TransPacific Partnership agreement won’t be available for at least a month, likely weeks after the Canadian federal election on October 19. The details will undoubtedly reveal more generous concessions to the multinationals. It will be up to the elected legislators in all twelve countries to approve or reject the TPP. In Canada, NDP leader Tom Mulcair has pledged to scrap the deal if elected as Prime Minister, explaining that the Stephen Harper government had no mandate to sign it during an election campaign when it is merely a “caretaker” government.

The U.S. website zerohedge.com calls the Trans-Pacific Partnership “a Trojan horse” and “a coup by multinational corporations who want global subservience to their agenda.” In no uncertain terms, it adds: “Buyer beware. Citizens beware.” [8]

Footnotes/Links:

[1] http://www.theaustralian.com.au/business/latest/tranpacific-partnership-deal-reached/story-e6frg90f-1227558154056

[2] Julia Belluz, “How the Trans-Pacific Partnership could drive up the cost of medicine worldwide,” Vox, October 5, 2015.
http://www.vox.com/2015/10/5/9454511/tpp-cost-medicine

[3] “Pacific Deal Rewrites Rules on Trade in Autos, Patented Drugs,” Bloomberg News, October 5, 2015.
http://www.bloomberg.com/news/articles/2015-10-05/pacific-deal-rewrites-rules-on-trade-in-autos-patented

[4] Council of Canadians, “Tell party leaders: Reject the TPP,” October 6, 2015.

[5] Conor J. Lynch, “Trans-Pacific Partnership’s Big Pharma giveaway,” Open Democracy, February 14, 2015.
http://www.opendemocracy.net/conor-j-lynch/transpacific-partnership%E2/80%/99s-big-pharma-giveaway

[6] http://ctj.org/ctjreports/2015/10/orrshore_shell_games_2015.php//executive

[7] Hadrian Mertins-Kirkwood, “Trans-Pacific Partnership a big win for corporate interests,” Rabble.ca, October 6, 2015.

[8] Tyler Durden, “Trans-Pacific Partnership Deal Struck As ‘Corporate Secrecy’ Wins Again,” Zero Hedge, October 5, 2015.
http://www.zerohedge.com

October 7, 2015 Posted by | Corruption, Economics | , , , , | Leave a comment

The Withering of Big Pharma?

By Martha Rosenberg | Dissident Voice | November 7, 2013

It used to be when a drug company settled illegal marketing charges that millions took its drugs under false pretenses, the news would be released on a Friday afternoon when no one would notice. That was then. Now almost all the drug companies have joined the Off label/Kickback club and the public doesn’t seem to notice or care.

On the surface, Johnson & Johnson’s $2.2 billion settlement this week for illegally marketing drugs to the elderly, children and the mentally disabled looks like a victory.  J&J’s subsidiary, Janssen Pharmaceuticals, will plead guilty to illegally promoting the antipsychotic Risperdal for “controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities,” reports Reuters. The promotions included a brazen kickback scheme to Omnicare Inc, a pharmacy supplying nursing homes, exposed by a whistleblower.

At least 15,000 elderly people in nursing homes die a year from drugs like Risperdal said FDA drug reviewer David Graham in Congressional testimony a few years ago. Eli Lilly who makes the similar drug Zyprexa and AstraZeneca who makes Seroquel have also settled charges that they churned the elderly drug market at the price of Grandma and Grandpa’s lives.

But it is not a victory. J&J made $24.2 billion off Risperdal from 2003 to 2010 and shareholders won’t even notice this week’s nano loss. J&J milked Risperdal for all it was worth and the patent had already run out by the time it was charged with illegal schemes. Other drug giants charged with illegal marketing schemes–Abbott for Depakote, Pfizer for Bextra,  Eli Lilly for Zyprexa, AstraZeneca for Seroquel, GlaxoSmithKline for Paxil and Merck for Vioxx–also got their money’s worth before the trivial nuisance of suit. Many, like Pfizer who illegally marketed its seizure drug Neurontin while under probation for illegal Lipitor activities–are brazen and shameless repeat offenders.

Many say the only justice that will get Big Pharma’s attention is frog marching the CEOs off to prison and/or cutting them off from their lucrative public trough of Medicare, Medicaid and military health programs.

Still, Big Pharma’s audacious business plan of asking forgiveness not permission is winding down. Not because Pharma, prescribers, consumers, regulators and health officials have seen the light but because there are no more big drugs to pimp. An estimated 100,000 workers will be losing their jobs at Pfizer, Sanofi, Roche, GlaxoSmithKline, AstraZeneca and Merck reported Yahoo finance last month.

Only two new drug campaigns seem to be brewing and they require a major suspension of reality on the part of doctors and patients. One tries to convince people with low back pain they actually suffer from ankylosing spondylitis an arthritis-like condition that causes chronic inflammation of the spine.  If your spine is stiff when you wake up in the morning you can take an immune suppressor like Humira which puts you at risk of tuberculosis and lethal viral, fungal and bacterial infections while costing you $12,000 to $17,000 a year. Line forms to the left.

The other, even more brazen campaign, tries to convince people with insomnia, tiredness during the day, moodiness and relationship problems that they actually suffer from Non-24-Hour Sleep–Wake Disorder, a disorder that affects mostly blind people. You don’t have to be blind to have the disorder, says the new Pharma message even though there have been fewer than 100 cases of sighted people with non-24 reported in the scientific literature. It sounds like a stretch but so did convincing people with job, money and marriage problems they really had depression or bipolar disorder.

Still it is obvious the bloom has fallen off the Big Pharma rose and it is now paying the piper for the high-flying party with drug settlements like Johnson & Johnson’s this week. But that doesn’t mean shady marketing, hidden risks, kickbacks and outrageous prices are gone from the medical field. They have just moved to the Medical Device industry.

~

Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: martharosenberg@sbcglobal.net.

November 8, 2013 Posted by | Corruption, Deception, Economics | , , , , , , , , | 1 Comment