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Saturday, September 24, 2016

Big Pharma Spent Nearly $1 Billion Lobbying Government to Push Opiates — and It Worked

September 23, 2016   |   Alice Salles

(ANTIMEDIA— Op-ed) The pharmaceutical industry is often the target of relentless criticism. But while the concerns brought up by said Big Pharma critics are often legitimate and unsettling, they are also the product of heavy government intervention.
Because misdiagnosing the disease — in this case, Big Pharma’s influence and its consequence — has been the standard approach among reformists, proposed medical solutions continue to kill patients. In other words, as reformists propose still more regulation and government involvement, Americans who fall victim to the cozy relationship between Big Pharma and government continue to suffer.
Digging deeper and finding the root of the problem is the best approach — but only if your goal is to truly solve the problem. When honest doctors see a problem, they let their patients know, whether the truth hurts or not. As a nation, we must have a difficult conversation on this topic, and unfortunately, some of what we’ll learn will be upsetting.

Big Pharma Lobby More Powerful Than Ever

As reported by Mother Jones, the opioid crisis in America has worsened considerably, in part because Big Pharma lobbyists continue to spend money to influence Congress. So far, Mother Jones reports, the pharmaceutical industry has spent $880 million to deter lawmakers from passing legislation that restricts patient access to opioids.
As the number of accidental fentanyl overdoses increasesprompting “police officers [to] carry Narcan when responding to calls,” the opioid lobby “has been doing everything it can to preserve the status quo of aggressive prescribing,” according to Dr. Andrew Kolodny, an opioid reform advocate.
To combat the crisis, which started to alarm some lawmakers several years ago, state lawmakers in New Mexico tackled the issue by reviewing a bill sponsored by former Democratic Senator Bernadette Sanchez in 2012 that would have “limited initial opioid prescriptions for acute pain to seven-day doses” within state borders. Sen. Sanchez hoped to “make addiction less likely and provide fewer pills that could be resold on the black market.”
But the application of the drug war approach (meaning more restrictions on drug commerce) to yet another dependency issue eventually failed at the state level, thanks mostly to lobbyists working for Big Pharma, Sen. Sanchez told theAssociated Press. But the industry’s fight against restrictions had just started.
Because prescription restrictions like the one proposed in New Mexico would have impaired their money-making game plan, the industry continued with its aggressive campaign to gain support from the public.
Every year,” the Daily Beast reported in 2015, “pharmaceutical companies spend over $3 billion on direct-to-consumer ads.” And unfortunately, these ads work. “[A] patient who requests a specific drug will get it most of the time,” the Daily Beastnotes. With government rules making it hard for doctors to say “no,” it’s easy to see why so many people are able to maintain their addictions.
Big Pharma has never ceased to influence us through leading physicians, who often “get to influence prescribing practices.” Pharmaceutical money that goes to “academic physicians in research” continues to flow freely. As the Daily Beast explained“these physicians ‘leaders’ … get to influence prescribing practices—since researchers and consultants are, well, experts.”
The result is predictable.
Since “practicing physicians are influenced far more by guidelines, esteemed academic physicians, and opinion pieces in prestigious journals than we are by a deli platter and a smiling drug [representative],” pharmaceutical companies invest a great deal of their money and time into swaying doctors’ opinions and keeping them favorable to their products.
By combining heavy advertising to patients with their aggressive “bribing” of leading physicians, pharmaceutical leaders are also able to sway official guidelines and regulations.
Since “at least $1.4 Billion [of pharmaceutical money] went to research” in 2013, it’s safe to say some doctors are heavily influenced by pharmaceutical research monies.
And while little data is available on the link between industry-backed research and public policy, a study from 2003 entitled “Scope and Impact of Financial Conflicts of Interest in Biomedical Research” showed about 43 percent of all scientific investigators involved with academic research had received gifts and discretionary funds from industry sponsors. The study concluded “[f]inancial relationships among industry, scientific investigators, and academic institutions are widespread. … [and] conflicts of interest arising from these ties can influence biomedical research in important ways.”

Government Agencies Packed with Industry Professionals

Governmental regulatory bodies like the U.S. Food and Drug Administration only allow drug-related products to be sold in the United States once the company is capable of “[submitting] evidence that [the drug] is safe and effective.” Regulators rely heavily on research provided by the industry. That research is then reviewed and approved by doctors at the FDA’s Center for Drug Evaluation and Research (CDER), an organization that employs physicians such as Michael Klein, Ph.D.(pdf) as the Controlled Substance Staff (CSS) director. Klein also happens to serve as the Vice President of Stellar Biotechnologies, Inc., the company behind the production of Keyhole Limpet Hemocyanin (KLH), a “safe immunostimulating protein with an extensive history of use in vaccine development and immunological research.”
Grail Sipes, J.D., who serves as director of the CDER Office of Regulatory Policy, is a former partner at the business and corporate law firm, Covington & Burling, LLP. Her husband, Christopher Sipes, is the attorney who represented biopharmaceutical company Amarin Corporation in a suit against the FDA that eventually granted  “five-year, New Chemical Entity (NCE), marketing exclusivity for Vascepa(icosapent ethyl) capsules” to the company.
Members of the government board responsible for reviewing, accepting, or refusing drug applications are directly involved with the pharmaceutical industry, making it clear how deep the pharmaceutical industry’s influence runs.
As the government’s official and ongoing war against substances such as heroin remains in full force, the pharmaceutical industry continues waging its own war for influence, employing “an annual average of 1,350 lobbyists in state capitals from Olympia to Tallahassee” while fighting hard to keep illicit drugs illicit.

If the Revolving Door is the Problem, What’s the Solution?

With pharmaceutical industry leaders employing former government officials and vice-versa, the fight to sway public policies in a way that benefits special interests is ongoing, and it costs these companies a great deal of money. These same companies are only able to engage in this influence war because they hold monopolies over the products they produce and market. So, proposing more restrictions on these organizations — whether or not they are the reason we have an opioid epidemic in the first place — is misguided simply because more restrictions will only boost these very monopolies.
Instead, how about putting an end to the very agency that allows this corporate welfare game to continue?
According to economist Marc Joffe, removing the regulatory burden from the government could benefit patients by “[letting] pharmaceutical companies sell whichever medications they believe to be safe and effective — with the understanding that patients can win large judgments if the companies fail to produce and market their treatments responsibly.”
In the absence of an authority figure telling consumers which companies are safe, Joffe contends, competition will thrive, and smaller, more patient-oriented groups will emerge to respond to a real demand for quality products.

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