February 2, 2015
It’s called a 21st century bill, but this extraordinarily dense legislative proposal follows an old, 20th century paradigm: if there’s an illness, create some new government-subsidized drugs to throw at it. Action Alert!
The “21st Century Cures Act” is close to 400 pages long. If enacted, it would dramatically alter the ways pharmaceutical and medical device products are regulated in the US.
The bill has not yet been introduced, but has broad support in the Republican-controlled House Energy and Commerce Committee. It appeared that committee chair Fred Upton (R-MI) had broad bipartisan backing until his lead collaborators, Rep. Diana DeGette (D-CO) and ranking member Rep. Frank Pallone (D-NJ), pulled their support. DeGette did not give a reason for her withdrawal; Pallone stated it was because the proposal creates more problems in the healthcare system than it solves, and that the draft bill does not include “any real dollars to fund additional basic research at the NIH.”
We are opposed to the bill as it stands and are working with Energy and Commerce to see if our major concerns can be addressed. Although its stated purpose is to modernize medicine, it is mostly focused on streamlining the drug approval process and extending market exclusivity (and therefore profits) for drugs. In other words, it basically throws more money at an old system, while expecting things to change. This is a 20th century paradigm, not a 21st century one.
Market exclusivity for drugs is a major part of the problem in healthcare today and especially the cost of healthcare. Giving drug companies even more years of government enforced monopoly is no solution.
- This bill would create a fifteen-year market exclusivity for what are called specialty drugs—that is, drugs for which there is deemed to be an unmet medical need, usually due to the complexity or limited extent of the disease. By contrast, current market exclusivity is five years for conventional drugs and twelve years for specialty drugs. This is after FDA approval and is on top of the grant of government monopoly conferred by the patent. If you wonder why medicine costs so much, stop right here. Government both enforces drug monopolies and also ensures that medicine will be dominated by drugs. Natural therapies are quashed by issuing gag orders on producers of them.You won’t be surprised to learn that more and more drug applications to the FDA by drug companies are for drugs that are characterized as specialty drugs. Who wants to submit a drug that gets five years of monopoly when by tweaking the name you can get twelve years?
- The bill would also extend exclusivity for two years for significant improvements to existing drug molecules. This might include developing new delivery systems, new drug combinations, or new formulations that lead to fewer adverse events. You can be sure that this will result in drug companies changing a drug ever so slightly, with very little added benefit, just to extend exclusivity, with a wink and a nod from regulators. Very few completely new drugs have been introduced in recent years; they are usually variations of old drugs, and this bill would only exacerbate that trend.
- If the pharmaceutical company can show that an existing drug can also treat a rare medical condition (an “orphan disease,” that is, one that affects only a small percentage of the population), the drug will then be known as an “orphan drug,” and the company will gain an additional six months of market exclusivity.
- The bill establishes a new designation for antibacterial drugs: “Qualified Infectious Disease Products.” These are drugs that treat pathogens which have the “potential to pose a serious threat to public health.” These drugs will receive, under this bill, an additional five years of market exclusivity. Outrageously, companies can transfer up to twelve months of that exclusivity to “one or more drugs”!
- Approval for new antibiotics would also be streamlined—but with no discussion about investigating the natural alternatives that already exist. These include silver, intravenous vitamin C, the herbs cat’s claw and artemisia, some essential oils, grapefruit seed extract, or hyperbaric oxygen therapy.
- While it charges the CDC to monitor any overuse of antibiotics, the bill fails to give specific guidance about common routes of exposure such antibiotics in animal feed. In fact, there is no mention whatsoever in this massive document of antibiotics in meat.
- The bill charges the Centers for Disease Control and Prevention (CDC) to conduct a review of Advisory Committee on Immunization practices—specifically with regard to the transparency and consistency of its procedures in formulating and issuing vaccine recommendations. One change we would like to see in this area is to ask the government, as part of any such process, to investigate all adverse event report (AER) data as well. As we reported previously, the government currently refuses to look at AERs, taking the position that correlation does not equal causation. We believe the data raises some serious red flags that need to be investigated thoroughly.
- There is also an expedited review and approval process for “breakthrough vaccines,” especially in the face of public health crises, but it doesn’t put important safeguards in place to protect the public, such as informed consent or post-market studies.
- The Department of Health and Human Services (HHS) would have to develop and carry out a longitudinal study to help patients with chronic diseases. This may sound good, but we’re concerned that the committee in charge will not include input from integrative doctors, nutritionists, and others in the integrative medical community. True chronic disease prevention needs to include lifestyle and nutrition factors, including dietary supplements. Nor do we think that solutions are likely to come from a government committee that will inevitably be heavily influenced by special interests.
This legislation is not, however, all bad news. We are intrigued by several features of the bill:
- Besides the aforementioned accelerated approval for antibiotics, this bill would also create a fast lane for breakthrough medical devices and drugs for which an unmet medical need is determined to exist. The FDA may approve such a drug if early-stage clinical data provides “sufficient evidence” of safety and effectiveness. We are not sure what this means and would rather have the government leave “clinical effectiveness” determinations to the medical profession, but it might be a start toward reform of the current broken system.
- Very sick patients who need access to experimental drugs before they are approved may see more expanded access programs. The bill would require greater transparency from drug companies for these programs, and would also create an expanded access task force to make recommendations to Congress for further reforms. We have advocated for patients to have the right to access experimental drugs and therapies without FDA intervention.
- The bill provides what may be a new evidentiary standard:surrogate endpoints. In clinical trials, some outcomes are not of practical importance themselves, but may reflect and stand in for outcomes that are very important indeed. For example, blood pressure is not in itself an important number, but its relationship to strokes and heart attacks means it is vital, and measuring blood pressure changes in small groups of patients is much more convenient.A change of this kind is greatly desired by drug companies and easily abused. For example, it is difficult to show that certain blockbuster drugs like statins save lives because the evidence is lacking. It is easier to show that they accomplish something that could theoretically be linked to saving lives. This is analogous to studies which assume that because people have health insurance, they become healthier, even though the evidence does not back this up. What is potentially promising here is that the emphasis is on clinical data (what happens when patients are treated) rather than just random clinical trials (RCTs). But the language as it stands would probably cause more mischief than benefit.
- The bill would also allow a drug sponsor to submit real-world evidence to the FDA in support of drug study requirements, basing evaluations of safety, risk, and benefits from sources other than RCTs, and would include observational studies and registries. While this would apply only to already approved drugs, it does represent another useful precedent and a shift from the RCT as the sole evidentiary standard. Of course, we would like to see real-world evidence allowed for food, dietary supplements, and natural treatments as well..
- Finally, there is a section encouraging telemedicine and new technologies to improve the delivery of quality healthcare services to Medicare beneficiaries. We have fought against Medicare rules that make it difficult for doctors to use telephone, email, etc., to communicate with their patients (or at least to get paid for it!), and
- this is a step in the right direction.
This is a huge bill, one whose depths we have not yet fully plumbed. We will, as always, keep you posted on new developments as the bill is introduced and makes its way through Congress. Be prepared for some major opportunities to make your voice heard!
Action Alert! Since the bill hasn’t yet been formally introduced, now is the best time to amend the language. This bill is expected to move quickly, so it is essential that we express all of our concerns now. Write your senators and representative, explain your problems with the bill, and ask them to amend it before it’s introduced. Please take action immediately!
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