I find medicine is the best of all trades because whether you do any good or not you still get your money. -- Moliere: "A Physician in Spite of Himself," 1664
While very few media outlets are reporting on it, the 21st Century Cures Act is making its way through the legislative process. The bill was approved by the House Committee on Energy and Commerce on May 19 and referred to the very powerful House Ways and Means Committee for consideration.
Sponsored by U.S. Rep. Fred Upton (R-Mich.), it is co-sponsored by three Democratic representatives and one additional Republican.
The full title of the bill gives a clearer understanding of its aims: A bill to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. In a nutshell, this bill aims to increase funding for research, reward discoverers with capstone grants, create greater efficiency in the clinical trials, and reward innovative businesses for introducing drugs that fill unmet needs.
All of this "sounds" like a promotion of the American values of hard work, innovation, and business -- but multiple provisions only line the pockets of Big Pharma at the expense of consumers.
Fast-Tracking Drug Approval
Probably the most damaging of the fast-track provisions within this bill is in Section 2061: "BROADER APPLICATION OF BAYESIAN STATISTICS AND ADAPTIVE TRIAL DESIGNS."
Bayesian statistics is a very old principle discovered by Thomas Bayes in the 18th century. Without going into complicated mathematical jargon, the theorem is a method of relating current results with prior results to form a progressively descriptive model.
This provision gives the FDA the power to incorporate these statistical methods into clinical drug testing. There are countless appropriate applications of Bayesian statistics, but drug testing might not be one of them.
Rather than treating each trial as a single statistical event, the Bayesian statistical model forms a progressive analysis of the data, which in turn can "hide" a lot of the earlier mistakes during testing.
The "Innovation Crisis" Myth
The belief that we have an innovation crisis when it comes to drug company research is an outright lie that a large portion of the population, including politicians, have bought hook, line, and sinker.A 2012 study in the
British Medical Journal found that for every $1 that the pharmaceutical companies spend on R&D, they spend $19 on advertising their product to the general public and doctors.
Think on this:
The "American Way" of innovation has always been, "Build a better mousetrap, and the world will beat a path to your door." If these drugs are so profound, why do they need so much advertising -- especially to consumers who don't understand the differences in efficacy between a new drug and its older counterpart.
Even worse, the bill itself forces the FDA -- within 18 months -- to revise its policies on the dissemination of drug information, primarily targeting the FDA's tight control over how drug companies advertise over social media. In a sense, this could open the door to a massive explosion of drug company advertising of new drugs.
While this might be seen by some as a "free speech" issue, the average consumer does not have enough information available to make a reasonable choice between a new drug and an older one, even if the older, cheaper drug works just as well.
This has long been a problem in the broken health care system, with the AMA having policies addressing this:
Physicians serve patients not because patients exercise self-determination but because patients are in need. Therefore, a patient may not insist on treatments that are inconsistent with sound medical practices. Rather, physicians provide treatments that are designed to make patients well, or as well as possible.
When patients are bombarded with advertising, it only serves to worsen this condition -- that doctors have to make the best choice, not the patient's belief in the advertising, when choosing the best treatment option.
Extending Exclusive Marketing Rights
Most drug companies have between 3 to 7 years of exclusive marketing rights after a drug hits the market. Many drugs are introduced to the market after the patent expires because of the length of testing and development -- exclusivity is a totally different privilege granted by statute.
Some limited-use drugs can currently apply for a 12-year exclusive marketing rights exemption, and some drugs are given extended marketing rights due to improvements in the drug.Subtitle H extends certain drugs exclusivity to 15 years, but some
critics contend that almost any new drug could qualify for this exemption just by wording the usage and description of the drug properly on the application.
According to the Generic Pharmaceutical Association (GPhA), 51 percent of drugs prescribed are generics, but these prescriptions only make up 8 percent of the total drug spending in the U.S.
Drugs with exclusive marketing rights (the other 49 percent) make up 92 percent of the total amount spent on drugs in America.
When considering the advertising to R&D ratio (19-1), it is almost ludicrous for politicians to even consider extending the marketing exclusivity for any drug coming to market.
The GPhA goes so far as to stating that this bill could set back the consumer's affordability and availability of generic drugs by 30 years.
Call to Action
More attention needs placed on this bill as it makes its way quietly through the legislative process. This is a bill that affects almost all Americans -- some only occasionally take medicines for acute problems, but nearly 70 percent of all Americans take at least one drug a day for chronic conditions.
This is an issue that affects a broad base of Americans, regardless of political ilk.
The FDA was created to protect Americans, to ensure the quality of our food and drug supplies, and to protect the innovative powers of business. We need to make sure that its first and foremost role is to protect Americans, not line the pockets of Big Pharma.