Protecting America’s Health: The FDA, Business and a 100 Years of Regulation by Philip J. Hilts (2003)
Wow! What an eyeopening book! Well written and full of very specific circumstances, like why a bad drug is allowed to keep being prescribed when EVERYONE knows it actually kills people and fails as an antibiotic as well. Highly recommend reading this book so that if enough people know about the evils of Big Pharma, maybe we can change things!
p. 130 – Blair [FTC chair] was not sure it [drugs] was a good topic.The economics of it were complex, the industry was new and no one had studied it, no good industry numbers were available, and the industry was riding a popular high because of the success of antibiotics. And, of course, the drug industry had enormous cash reserves, COULD RETALIATE FORCEFULLY and effectively if they did not like the bent of the hearings. But through the years, Till and others had been saving documents and accumulating data, because they knew the day of reckoning for the drug industry would come.
Blair was not convinced until one afternoon when he was looking at FTC reports on about two dozen different industries. Until that time, drug companies had been listed under the CHEMICAL industry. But now, someone at the FTC had broken them out separate.y, and IT STOOD OUT. The pharmaceutical industry was not only the biggest profit maker, but the levels of profits were DOUBLE the industry average, 19% of investment after taxes. Blair called Till [FTC economist serving with Blair] and together they looked at the numbers. “My God, just look at those profits!” he said to her. She allowed that she had never seen any numbers like it in her years as an economist. The decision to go ahead with the investigation of the drug business was taken that day.
Thus happened in 1957 and later. Walton Hamilton was a lawyer with a sore throat. When he went to the pharmacy.
p. 129 – When he went to the drugstore, the pharmacist told him the antibiotic would cost fifty cents per pill, $10 for a five-day supply ($100 in today’s currency) — a lot of money for a simple sore throat. Hamilton had worked as a consultant for the antitrust division of the Justice Department. . . . [He] called his doctor because he suspected doctors had no idea what the cost of medicine was. He was right. His doctor said at least tow other antibiotics would be fine, and that he would check the price and call back. He did. “I’m sorry, but they’re all the same price,” he told Hamilton.
“Exactly the same? the lawyer asked.
“To the penny.”
“I assume they are made by the same company then?”
“No,” the doctor said, “They are made by three different companies.”
Hamilton knew about price-fixing issues. He was married to an economist one step closer to those issues, Irene Till, of the Federal Trade Commission (FTC). He smelled a rat. Harris notes that Hamilton talked it over with his wife, who was equally surprised at both t he high prices and the “coincidence”
That experience led, ultimately, to a moment in 1957 when Till was working for the Senate subcommittee on antitrust monopoly issues.
Hence we ended up the hearings I copied in the first quote. He goes on with insights such as one singled advertisement of Sigmamycin, and antibiotic. The ad feature images of 80 “doctors” business cards, implying they supported this medication. “John Lear, science editor for the Saturday Review magazine…” began to research this and discover that all the cards portrayed were false: false address, no such phone numbers,
p 132 – For years, academic doctors and even reputable company officials had said THERE SHOULD BE SOME LIMITS TO THE PROFITS OF DRUG COMPANIES. SEVERAL IDEAS HAD BEEN SUGGESTED LIKE CAPS ON PROFITS AND RULES THAT WOULD REQUIRE to limit their monopolies on a drug to three years after approval and marketing. The proposition that companies could set their prices as HIGH AS THE MARKET WOULD BEAR – – the market being their sick and dying fellow citizens — made many uncomfortable. But the issue was never confronted until the Kefauver hearings.
Short version: the use of one killer drug did not stop until the company’s patent expired.
Tidbit of note, p. 119: “. . . the FDA was inspecting about 96,000 manufacturing and processing plants in the United States, but he work force was such that inspectors made it to each plant about once every TWELVE  years.”
A subsequent chapter discussed the necessity of safety testing aka regulation. But of course, the industry was opposed to that; they believed that some deaths were acceptable collateral damage. They drummed up support from the public based on the usual lies and such.
p. 296 – The public assault began just after the election of 1994, and started essentially with salvos from Newt Gingrich just before and immediately after the election. Gingrich said the FDA was the “No. 1 job-killer in America (a hard statement to support). [now it is Obamacare I think] He charged that the FDA discouraged innovation and prevented PROFITABLE PRODUCTS from coming to market. Gingrich also went after the commissioner personally. He called David Kessler “a thug and a bully.” The low level of the rhetoric was startling. Though American policies can be rough, this kind of rhetoric was unusually nasty, and was born of no apparent provocation to Gingrich.
The goal was to dismantle the FDA, to roll back the scientific standards of the 1962 law and turn over the “review” of drugs to PRIVATE COMPANIES HIRED BY THE DRUG MANUFACTURERS THEMSELVES. [Fox guarding the chicken house!] Information about drugs was largely controlled by those who made and sold them; now, the review of the safety and effectiveness of drugs was also to be handed back yo the manufacturers. The battery of organizations built up after the Reagan election and still going strong were now concerned in their efforts to discredit regulation in general and the FDA in particular. The groups shared two general sources of funds. There were half a dozen foundations of the extreme right that provided several million dollars annually to the cause. In addition the new Republican leadership made it clear that industry’s traditional ploy of giving to both sides to hedge bets would no longer be acceptable. Gingrich stated plainly that BUSINESSES SHOULD CHOOSE THEIR SIDE and stick with it, because he and the new leaders of Congress intended to hold them accountable for donations to the opposition. Having made this assertion in public, the Republicans then went out to collect funds from the traditional adversaries of the FDA. They had no trouble raising millions from the tobacco companies, and although the drug companies were wary of the NEW RIGHT programs because injury to the FDA could mean injury to the credibility of their products, they felt obliged to contribute some additional millions to those who would be leading the Congress for, it seemed, at least a few years.
Tidbit from p. 307 – “But in matters of health, life, and death, the values of commerce are not the starting point. It is not permissible to knowingly cause a certain number of deaths and injuries in order to KEEP COMPANIES PROFITABLE. “
Page 308 – It is vital to build a system of making and selling drugs much more carefully than the making and selling of BROOMS. “Let the customers decide” or “let the free market function unfettered” may be acceptable for brooms, but it is UNACCEPTABLE in the realm of prescription drugs. Sometimes HEALTH MUST BE COUNTED FIRST, and business second. Newt Gingrich didn’t see it that way.”
p. 337 – Old-fashioned Politics
For a period in the last two decades of the century, regulation had become one of the most contentious and even inflammatory issues in politics and society. It was asserted that regulations, regardless of its type or APPARENT USEFULNESS, cost society MONEY and FREEDOM. But now after the fever has passed, in looking back over the whole history of the agency, it is clear that regulation has become a VITAL PART of society for both citizens and business. It has elevated the debate and the standards. It has added to FREEDOM as it has made medicines more reliable and safe to take. It has helped establish a base upon which more advanced medicines can be found and developed, guided by principles of medicine and science rather than hype. The lesson we can see through the past century of conflict is not that businesses may sometimes exploit citizens for profit, or that government agencies will sometimes make mistakes, but that regulation and commerce are part of the same equation of progress. The scientific facts and social understandings needed for progress are not created in industry, or in universities, or in government, but in all of them together.
The epilogue is a great title: Epilogue: Greed and Goodness
One of his major points was that he did some experiments to see what students would choose under various circumstances when a bad drug that actually killed people would do if they had the authority to do something about it. Short answer: when they played the role of the Board of Directors, they chose profit over ethics to stop making the drug. They did not see that a corporate board had a duty and obligation to the citizens first rather than shareholders. Other circumstances also were to keep selling the drug EVEN WHEN THEY KNEW IT KILLED people and was inadequate. Only when there was a citizen or consumer interested party on the board did anything else persuade some people to vote to stop making the drug — but not necessarily enough to win a vote.
So there you have it. Republicans want to privatize everything so businesses can make profit off our misfortunes of health and be responsible for developing and testing (maybe) the drugs they make, even when there are other drugs of the same kind already on thee market that are better. And as long as the board members maintain the fiction that they owe nothing to consumers, we are fucked.