mykeystrokes.com

"Do or Do not. There is no try."

“Lethal But Legal”: Rethinking Our ‘Rights’ To Dangerous Behaviors

In the last few years, it’s become increasingly clear that food companies engineer hyperprocessed foods in ways precisely geared to most appeal to our tastes. This technologically advanced engineering is done, of course, with the goal of maximizing profits, regardless of the effects of the resulting foods on consumer health, natural resources, the environment or anything else.

But the issues go way beyond food, as the City University of New York professor Nicholas Freudenberg discusses in his new book, “Lethal but Legal: Corporations, Consumption, and Protecting Public Health.” Freudenberg’s case is that the food industry is but one example of the threat to public health posed by what he calls “the corporate consumption complex,” an alliance of corporations, banks, marketers and others that essentially promote and benefit from unhealthy lifestyles.

It sounds creepy; it is creepy. But it’s also plain to see. Yes, it’s unlikely there’s a cabal that sits down and asks, “How can we kill more kids tomorrow?” But Freudenberg details how six industries — food and beverage, tobacco, alcohol, firearms, pharmaceutical and automotive — use pretty much the same playbook to defend the sales of health-threatening products. This playbook, largely developed by the tobacco industry, disregards human health and poses greater threats to our existence than any communicable disease you can name.

All of these industries work hard to defend our “right” — to smoke, feed our children junk, carry handguns and so on — as matters of choice, freedom and responsibility. Their unified line is that anything that restricts those “rights” is un-American.

Yet each industry, as it (mostly) legally can, designs products that are difficult to resist and sometimes addictive. This may be obvious, if only in retrospect: The food industry has created combinations that most appeal to our brains’ instinctual and learned responses, although we were eating those foods long before we realized that. It may be hidden (and borderline illegal), as when tobacco companies upped the nicotine quotient of tobacco. Sometimes, as Freudenberg points out, the appeals may be subtle: Knowing full well that S.U.V.’s were less safe and more environmentally damaging than standard cars, manufacturers nevertheless marketed them as safer, appealing to our “unconscious ‘reptilian instincts’ for survival and reproduction and to advertise S.U.V.’s as both protection against crime and unsafe drivers and as a means to escape from civilization.”

The problems are clear, but grouping these industries gives us a better way to look at the struggle of consumers, of ordinary people, to regain the upper hand. The issues of auto and gun safety, of drug, alcohol and tobacco addiction, and of hyperconsumption of unhealthy food are not as distinct as we’ve long believed; really, they’re quite similar. For example, the argument for protecting people against marketers of junk food relies in part on the fact that antismoking regulations and seatbelt laws were initially attacked as robbing us of choice; now we know they’re lifesavers.

Thus the most novel and interesting parts of Freudenberg’s book are those that rephrase the discussion of rights and choice, because we need more than seatbelt and antismoking laws, more than a few policies nudging people toward better health. Until now (and, sadly, perhaps well into the future), corporations have been both more nimble and more flush with cash than the public health arms of government. “What we need,” Freudenberg said to me, “is to return to the public sector the right to set health policy and to limit corporations’ freedom to profit at the expense of public health.”

Redefining the argument may help us find strategies that can actually bring about change. The turning point in the tobacco wars was when the question changed from the industry’s — “Do people have the right to smoke?” — to that of public health: “Do people have the right to breathe clean air?” Note that both questions are legitimate, but if you address the first (to which the answer is of course “yes”) without asking the second (to which the answer is of course also “yes”) you miss an opportunity to convert the answer from one that leads to greater industry profits to one that has literally cut smoking rates in half.

Similarly, we need to be asking not “Do junk food companies have the right to market to children?” but “Do children have the right to a healthy diet?” (In Mexico, the second question has been answered positively. Shamefully, we have yet to take that step.) The question is not only, “Do we have a right to bear arms?” but also “Do we have the right to be safe in our streets and schools?” In short, says Freudenberg: “The right to be healthy trumps the right of corporations to promote choices that lead to premature death and preventable illnesses. Protecting public health is a fundamental government responsibility; a decent society should not allow food companies to convince children to buy food that’s bad for them or to encourage a lifetime of unhealthy eating.”

Oddly, these are radical notions. But aren’t they less “un-American” than allowing a company to maximize its return on investment by looking to sell to children or healthy adults in ways that will cause premature mortality? As Freudenberg says, “Shouldn’t science and technology be used to improve human well-being, not to advance business goals that harm health?” Two other questions that can be answered “yes.”

 

By: Mark Bittman, Contributing Op-Ed Writer, The New York Times, February 26, 2014

March 2, 2014 Posted by | Consumers, Public Health | , , , , , , , | Leave a comment

“A Pill For Every Ill”: Consumer Drug Advertising Should Be Banned

Consumer advertising of prescription drugs is a massive public health experiment in which billions of dollars are spent each year. But this advertising is a blunt instrument where a sharp edge is needed.

Drugs have harms as well as benefits, and the harms are greater when drugs are indiscriminately prescribed. Consumer advertising, delivered to the masses as a shotgun blast, rather than as specific information to concerned patients or caregivers, results in more prescriptions and less appropriate prescribing.

There is no evidence that consumer ads improve treatment quality or result in earlier provision of needed care. Research has shown that the ads convey an unbalanced picture, with benefits and emotional appeals given far greater weight than risks. Clinicians can work to override these miscues, but this steals precious time from activities that can provide real benefit to patients. In the packed agenda of the patient visit, in which so many real concerns and evidence-based care are available to make a difference in people’s lives, the intrusion of marketing risks harm.

Advertising also provokes a subtle shift in our culture — toward seeking a pill for every ill. While there are many for whom stimulants and other medications can be a godsend, the case of attention deficit hyperactivity disorder is a prime example of how, too often, a pill substitutes for more human responses to distress. U.S. clinicians prescribe stimulant medication for A.D.H.D. at a rate 25 times that of their European counterparts. The complex decision to start a long-term medication should be motivated by the observations of teachers and parents and children, in the context of a relationship with a caring clinician − not stimulated by rosy ads.

Consumer drug advertising is banned in most of the world, although pharmaceutical companies are making a full-court press on the European Union, even while violating the limited guidelines for that advertising in the United States.

In the information age, in which more balanced sources of information on drugs should be widely available, biased pill-pushing messages are a public health menace. To advance the health of the public, the United States should follow the lead of the vast majority of countries, and ban direct-to-consumer pharmaceutical advertising.

 

By: Kurt C. Strange, Room for Debate, The New York Times, December 15, 2013

December 16, 2013 Posted by | Pharmaceutical Companies, Public Health | , , , , , , , | 1 Comment

“How Safe Are Pharmaceutical Supply Chains?”: An Organizational Mindset Is Necessary, Even If Costly In The Short-Term

GlaxoSmithKline announced this week that it is recalling some of its asthma drug Ventolin. The reason: its contract manufacturer said that the syrup bottles might have been contaminated with glass particles.

Last fall, in what 60 Minutes described as “the worst pharmaceutical disaster in decades,” 48 people died in a meningitis outbreak that was traced back to contaminated production in a compounding pharmacy in Massachusetts. The New York Times reported that the U.S. is suffering from a shortage of injectable drugs caused by quality failures at large manufacturers such as Hospira.

As a result of these and other stories, the quality of our medicines, or more precisely the failure in quality, has gained widespread attention.

Many believe the solution is to increase business investment in capital equipment. Hospira announced last year that it would spend hundreds of millions of dollars on a new state-of-the-art plant and quality and operations specialists. David Gaugh, vice president for the Generic Pharmaceutical Association, said that the perception that injectable drugs are produced in run-down facilities was “absolutely not true” and compared them to well-maintained vintage cars. This focus on technology might appear reasonable; but it is not sufficient.

The only way to guarantee that no defective drugs are ever produced is to never produce any drugs. None of us wants a world without medicine, and thus, we must live with some risk of quality failures in our drug supply chains. Because testing pharmaceuticals for every theoretically-possible contaminant or process deviation is prohibitively expensive if not impossible, drug quality must be built into the product through well-designed production processes, the use of quality ingredients and the consistent adherence to quality control procedures.

Aware of this, regulators long ago established “Good Manufacturing Practices,” known as GMPs, in the pharmaceutical industry. Operating in full compliance with these legally-required GMPs greatly reduces the risk of contaminated or misformulated product reaching the market. It seems that many of the plants highlighted in recent reports were not adhering to GMPs.

To address the problem, it is necessary that executives develop a quality-oriented mindset across the entire supply chain. For example, are employees empowered and encouraged to report deviations from GMPs, even if doing so is costly in the short term? Are deviations investigated and corrective actions put in place, even if doing so requires failing to meet promised delivery dates? Absent such an organizational mindset, quality failures will occur even with the best technology.

This soft side of quality management does not come easily. It often takes years of time to embed in a company, and even a longer time to regenerate if the culture has been undermined. Our research (with co-authors) has found that is difficult for companies to prevent a “decay” in GMP adherence even in their own factories.

When production is outsourced, ensuring adherence is more challenging. Recognizing this, the Food and Drug Administration is currently seeking comment on a “Guidance for Industry” document on quality agreements in contract manufacturing. The document focuses on clarifying responsibilities. Most companies engage in some form of certification, facility audits and product inspections with their contract manufacturers. While clear responsibilities and such actions can help to ensure quality at contractors, they do not guarantee consistent day-to-day adherence to good manufacturing practices.

Using FDA inspection data, we (and co-authors) have studied quality risk in the pharmaceutical industry. In one set of studies, we found that plants in a location with a different primary language than the firm’s headquarters operate with less GMP compliance than those with no language difference. Regarding outsourcing, we did not find an overall difference in quality risk between company-owned plants and contract manufacturer plants.

However, we did find a higher quality risk for small contract manufacturers and those subject to less regulation. Given this, we were not altogether surprised that these lightly regulated, small compounding companies like NECC were found to operate with high quality risk.

Taken together, our research provides empirical evidence that drug manufacturers are hard-pressed to consistently maintain high quality operations even in their own domestic facilities. This challenge is magnified when production is performed in offshore and outsourced plants. Our study and related studies reinforce the recent call to increase FDA regulatory scrutiny of compounders; this is clearly necessary and will help prevent future tragedies such as the recent meningitis outbreak.

However, regulatory and technical solutions alone are not adequate—an organizational mindset of compliance with GMPs is necessary throughout a drug’s supply chain, even if developing and maintaining this mindset is costly in the short-term.

 

By: John Gray, Aleda Roth & Brian Tomlin, U. S. News and World Report, June 21, 2013

June 24, 2013 Posted by | Big Pharma | , , , , , , , | Leave a comment

“A Very Sweet Deal”: Prescription Drug Price-Gouging Enabled By Congress

Republicans and Democrats don’t agree on much. But one thing they would agree on if they knew the facts is that because of the cozy relationship big drug companies have with our lawmakers in Washington, Americans pay far more for their medications than people anywhere else on the planet.

As a consequence, our health insurance premiums are much higher than they should be. And our Medicare program is costing both taxpayers and beneficiaries billions of dollars more than necessary.

Americans who are uninsured are at an even greater disadvantage: many of them have no choice but to put their health at risk because they can’t afford the medications their doctors prescribe for them.

Drug makers have so much influence in Washington that they’ve been able to kill numerous proposals over the years that would enable the U.S. government to regulate drug prices like most other countries do. Between 1988 and 2012, the pharmaceutical industry spent more on lobbying than any other special interest, forking over a total of $2.6 billion on lobbying activities, according to OpenSecrets.org. That’s far more than even banks and oil and gas companies spent.

That money helped them get a very sweet deal when members of Congress were drafting legislation that would eventually be the Medicare Part D prescription drug program. Drug makers were able to get their friends in Congress to insert language in the Part D legislation that prohibits the federal government from seeking the best prices from pharmaceutical companies.

According to a recent analysis by Health Care for America Now (HCAN), an advocacy group, the 11 largest drug companies reported $711.4 billion in profits over the 10 years ending in 2012, much of it coming from the Medicare program. They reaped $76.3 billion in profits in 2006 alone, 34 percent more than in 2005, the year before the Part D program went into effect.

“Americans pay significantly more than any other country for the exact same drugs,” said HCAN Executive Director Ethan Rome.

How much more do we pay than residents of other countries? Here are a few examples of what we pay on average for six brand name drugs compared to what residents of other countries pay, according to the International Federation of Health Plans:

— Celebrex (for pain) – U.S.: $162; Canada: $53

— Cymbalta (for depression and anxiety) – U.S: $176; France: $47

— Lipitor (for high cholesterol) – U.S.: $124; New Zealand: $6

— Nasonex (for nasal allergies) – U.S: $108; U.K.: $12

— Vytorin (for high cholesterol) – U.S: $123; Argentina: $31

— Nexium (for acid reflux) – U.S.: $123; Spain: $18

The Congressional Budget Office says that if Medicare could get the same bulk purchasing discounts on prescription drugs as state Medicaid programs already get, the federal government would save at least $137 billion over 10 years.

In his proposed budget for 2014, President Obama is asking Congress to require drug companies to sell their medications to Medicare at the best price they offer private insurance companies, which is what they are required to do for Medicaid.

On April 16, several members of Congress, led by Sen. Jay Rockefeller (D-W.Va.) and Rep. Henry Waxman (D-Calif.), introduced legislation to require drug companies to provide rebates to the federal government on drugs used by people who are eligible for both Medicare and Medicaid. One of the cosponsors was Independent Sen. Angus King, the former governor of Maine. The lawmakers noted that with the exception of Medicare Part D, all large purchasers of prescription drugs negotiate better prices. Their bill, they say, would correct excessive payments to drug companies, while saving taxpayers and the federal government billions of dollars.

As you can imagine, the drug companies don’t like what President Obama and the lawmakers are proposing. You can expect them to mount a multi-million dollar PR and lobbying campaign over the coming months to protect both their sweet deal with Medicare and their Wall Street-pleasing profits.

 

By: Wendell Potter, Guest Contributor, Politix, April 23, 2013

April 29, 2013 Posted by | Big Pharma, Medicare | , , , , , , | 1 Comment

“Influence Peddling”: Scott Brown Backed Letter For Top Legislative Priority Of Compounding Pharmacy Industry

Senator Scott Brown joined 10 other senators in sending a July letter to the US Drug Enforcement Administration advocating a top legislative priority of the compounding pharmacy industry, which is under scrutiny following a deadly meningitis outbreak.

The July 24 letter did not directly relate to the injectable steroids that have been blamed for 14 deaths and at least 185 sicknesses nationwide. But it addressed an issue central to that controversy: how these lightly regulated pharmacies can deliver their drugs and who can receive them.

The firm at the center of the meningitis outbreak, the New England Compounding Center, was sending drugs in bulk to doctors, a move that Governor Deval Patrick said has misled regulators. Compounding pharmacies are supposed to mix medications for an individual patient, based on a prescription from a doctor. But some have acted like drug companies, shipping thousands of doses to clinics and doctors’ offices, a practice Massachusetts officials say may violate state regulations.

Gregory Conigliaro, a co-owner of the New England Compounding Center in Framingham, and his wife threw a fund-raising event for Brown six weeks after the letter was written, at their home in Southborough. Brown’s campaign said he has received about $10,000 from the firm’s executives and relatives, which he donated to charity this week after the outbreak, which was traced to New England Compounding Center on Oct. 4. The senator is in a tight reelection battle against Democrat Elizabeth Warren.

For years, compounding pharmacies have delivered controlled substances, in bulk, to clinics, veterinarians, and other health facilities for use there, according to two specialists in the field. But in recent years, the DEA has interpreted federal law as requiring those pharmacies to deliver the drugs to ­patients whose names are on the prescription, or to owners, in the case of animals. The DEA argues that it is not a change in interpretation, enforcement, or policy and that agents pursue leads about violations when­ever they are known.

The industry position, echoed by Brown Friday, argues that the DEA’s interpretation creates a paramount safety concern. Industry officials say that medical professionals are in a better position to protect the drugs, which include strong opiates, from misuse or ­improper environmental conditions. Many must be injected by physicians and are sensitive to heat and light.

“As you know, they sometimes fall into the wrong hands,” Brown said Friday during an event in Dorchester, where he received endorsements from a coalition of police unions. “I was advocating getting it to the doctors, which I don’t think loosens regulations.”

But changing or clarifying DEA enforcement policy is also important to helping the industry avoid a legal gray area that could jeopardize its business, said Jesse C. Vivian, professor of pharmacy practice at Wayne State University in Detroit and the general counsel for the Michigan Pharmacists Association. Vivian and others say enforce­ment is now selective, meaning compounding pharmacies are at risk if DEA agents choose to crack down on them.

“What they’re really looking for is to legitimize what in fact they’re doing right now,” said Vivian, who is not involved in the industry’s lobbying effort, but believes the DEA is treating the industry unfairly.

The letter to the DEA’s top official, Michele M. Leonhart, was signed by a bipartisan group of senators. When a smaller group of senators signed a similar letter in 2011, Brown did not lend his support.

The July letter implores the DEA to open what is known as a rule-making process, which would allow the agency to take public input on whether it is ­interpreting current law correctly.

“DEA’s lack of action is a source of serious concern for us, our constituents, and the regulated community,’’ wrote the senators, including Brown.

“It is difficult to argue that controlled substances are more safely maintained by family members or animal owners than they are by trained, ­licensed, regulated doctors who would administer those substances only to legitimate ­patients,” it continued.

Brown emphasized Friday that the type of drugs covered by the letter are different from the steroids involved in the meningitis outbreak, and he once again urged a full investigation of the outbreak. He said that the Food and Drug Administration, not the DEA, oversees the safety of drugs at the center of the meningitis problem.

Brown referred inquiries about who asked him to sign the DEA letter to his campaign, which has declined to comment on that question. But Brown said there was absolutely no connection between his signing the letter and his fund-raising from industry officials.

“It’s a tragedy, and for anyone to try and politicize it is just wrong,” he said. “I’ve had hundreds and hundreds of fundraisers. There’s absolutely no connection. That’s the old spaghetti-­on-the-wall-trick, see what sticks.”

His campaign has said he would donate the $10,000 that came from company executives to the Meningitis Foundation of America.

The compounding pharmacy industry’s lobby, the International Academy of Compounding Pharmacists, lists the delivery issue raised in the letter as the first of three legislative priorities on its website. In June, a month before the letter was written, members of the organization descended on Capitol Hill to make their case, according to the website, seeking face-to-face visits with lawmakers. A spokesman for the organization did not respond to two calls and an e-mail requesting comment.

The DEA says it has no latitude in changing its enforcement of the Controlled Substances Act, which governs how drugs can be delivered, unless Congress acts.

“We have to enforce the law the way it’s written,” spokeswoman Barbara Carreno said.

 

By:Noah Bierman and Frank Phillips, The Boston Globe, October 12, 2012

October 15, 2012 Posted by | Election 2012, Senate | , , , , , , , | Leave a comment

   

%d bloggers like this: