The statistics on death are impressive – one out of one die. But that’s no reason not to deny the grim reaper his day until absolutely necessary.

Recently Congress passed “Right to Try” legislation which grants terminally ill patients the right to access investigational drugs that haven’t yet proven their clinical efficacy. They are required to pass initial safety testing.

What more can be done?

Paul J. Marangos, CEO of Biomedica Partners, writes in The Wall Street Journal that he believes much more can be done. Marangos spent 13 years at the National Institutes of Health and co-founded five biotech companies in the ensuing 30 years, all focused on developing cures for terminal diseases. With this experience, he has some insights on the process of bringing new cancer cures to market.

His first complaint is the lengthy FDA regulatory process. The Phase III clinical trials, which involve many hundreds and sometimes thousands of patients, are by far the most costly and time-consuming requirement for FDA approval. This phase has been eliminated in this new legislation, but only for terminally ill patients.

His second complaint concerns the strict stipulations for obtaining patents, which require demonstrating that the treatment works in the relevant laboratory experimental models and that it is not obvious to those in the industry. Getting patents can take five years or more, representing a substantial risk for the sponsoring company. Moreover, much of the existing scientific research is unpatentable. Very often biochemical data is published first, and then after a period it falls into the public domain.

Proposed Solutions

Marangos suggests the following reforms:

• Reduce the FDA approval requirements so that treatments for terminal disease no longer have to go through Phase III clinical trials. He believes one Phase II clinical trial of at least 100 patients is sufficient. This would reduce the time and expense of brining new drugs to market.
• Make this change retroactive – This would allow all treatments currently in Phase III trials to be immediately approved. According to the trade group PhRMA, there are more than 200 Phase III trials currently under way just for cancer drugs. There are 26 more in Phase III for Alzheimer’s Disease.
• Mandate a 10-year period of marketing exclusivity on treatments for terminal diseases. This would eliminate the need for patents, shortening the process and making unpatentable research commercially available.

These changes would incentivize pharmaceutical companies to focus more on terminal disease treatments, greatly enhancing our ability to fight diseases like never before. Innovative start-ups would multiply to explore treatment ideas off the beaten path, as happened before with the passage of the Orphan Drug Act of 1983, which granted exclusivity to treatments for rare disease and gave rise to many new drugs.

The usual excuse for not making such changes is the concern for safety. But Phase III trials are not about safety – they are about efficacy. When treating terminal diseases there is by definition little hope of success with currently available treatments. Let’s make it easier to try new approaches and new drugs while the terminally ill still have time. There’s little to lose when the prognosis is death.

I have long distrusted the use of juries to determine guilt or innocence in cases of scientific evidence. Like all physicians, I have practiced my entire career under the threat of malpractice litigation.

A recent ABC News report cited a Harvard study that concluded 75% of physicians in low risk specialties, and 99% of those in high risk specialties, will be suited at some time in their careers. Although I have experienced only one small nuisance lawsuit that was quickly settled in my career, the fear of a significant claim that could ruin your reputation and your future is real. If the issue comes down to a clear understanding of the scientific evidence presented, will a jury of non-medical, non-scientific peers be able to make the correct determination?

Recent jury determinations suggest the answer is no. The latest example is the verdict in the Monsanto trial in California that concluded Monsanto’s herbicide glyphosate, used in the popular weed-killer RoundUp, caused the defendant’s cancer. The jury awarded Dewayne “Lee” Johnson $289.2 million in damages for allegedly causing his non-Hodgkin’s Lymphoma.

To be sure, the defendant is suffering from this rare and painful condition and the jury was understandably sympathetic to his plight when confronted with gory photos of the lesions that covered up to 80% of his body. The problem is the scientific evidence presented is strongly in favor of the conclusion that glyphosate doesn’t cause cancer.

The Wall Street Journal editorial board cites one comprehensive study, published last November in the Journal of the National Cancer Institute, which investigated cancer incidence among nearly 45,000 licensed pesticide applicators who had been exposed to glyphosate. The study found “no evidence of an association between glyphosate use and risk of any solid tumors or lymphoid malignancies” – including non-Hodgkin’s Lymphoma. Even the Environmental Protection Agency, hardly a supporter of corporations, has likewise concluded that glyphosate is safe.

The only suggestion that there is a connection between glyphosate and cancer comes from the controversial work of the World Health Organization’s International Agency for Research on Cancer. WSJ says this group over the years has claimed pickled vegetables and “very hot beverages” may cause cancer. Its risk assessments suggest that working as a barber or hairdresser is only slightly less hazardous than being exposed to mustard gas. Therefore, it wasn’t unexpected when this group claimed in 2015, without evidence, that glyphosate is also “probably carcinogenic.”

Further investigation of this claim by Reuters revealed WHO had repeatedly ignored and omitted evidence that showed no link between glyphosate and cancer. Christopher Portier, an adviser who worked on the group’s glyphosate determination, was concurrently accepting payments from Lundy & Lundy, a law firm behind several cancer-related class-action lawsuits. The same Mr. Portier testified for Mr. Johnson in the Monsanto trial.

Talcum Powder Scare

If this all seems familiar, it may be because a similar non-scientific verdict was handed down one year ago when someone suited Johnson & Johnson for causing their cancer after years of using their baby powder. The jury awarded the defendant $417 million for failing to warn her about the dangers of their product. The American Cancer Society says there is no evidence that talcum powder can cause cancer since they removed trace amounts of asbestos from the product over 40 years ago. (see earlier post The Talcum Powder Cancer Scare)

The judge in that trial awarded Johnson & Johnson a new trial and the same is likely to happen in the recent Monsanto verdict. When juries dismiss solid scientific evidence in sympathy for the plight of the defendant, we all suffer a disservice. We become unnecessarily fearful for our safety and corporations are forced to remove effective products from the market that make our lives easier.

The Monsanto verdict will undoubtedly lead to many more lawsuits. WSJ says they are facing 5,000 similar suits. Johnson & Johnson faces the same kind of response to the flawed verdict in their case. This kind of un-scientific thinking on the part of sympathetic juries will only benefit the law firms that make a killing on their mistakes.

Senator Bernie Sanders of Vermont has introduced legislation he calls Medicare For All. This would create a single-payer healthcare system similar to Canada, our northern neighbor. Side-stepping the question of whether or not this is desirable, let’s get to the economic question – Is it affordable?

In response to a recent post that concerned socialized medicine, one reader opined that the cost of such a system would actually be less than our current level of taxes plus healthcare insurance premiums and deductibles. Is there any truth to that statement?

Charles Blahous, well-respected economist at the Mercatus Center of George Mason University and a public representative to the Medicare Trustees, has the answer. Blahous has drawn several conclusions from his study entitled, “The Costs of a National Single-Payer Healthcare System.”

Medicare For all Would Place Unprecedented Strain on the Federal Budget

Blahous concludes this legislation would have the following effects:

• Increase in the Federal Budget of $32.6 Trillion during the first 10 years of implementation (2022-2031)
• Projected increase in federal healthcare commitments would equal 7 percent of GDP in 2022. This would rise to nearly 12.7 percent of GDP in 2031 and continue to rise thereafter.
• These are conservative estimates because they assume the legislation achieves its sponsors’ goals of dramatically reducing payments to health providers, and substantially reducing drug prices and administrative costs – all unproven expectations. If those assumptions are incorrect, the costs would dramatically increase over these projections.

Medicare For All Dramatic Federal Cost Increase Arises from Several Factors

The several factors that cause these dramatic increases in federal spending include:

• The federal government would become responsible for financing nearly all current national health spending, including individual private insurance and state spending.
• This legislation would increase federal health spending on the currently uninsured as well as those who now carry insurance by providing first-dollar coverage of their healthcare expenses across the board, without deductibles or copayments.
• This would expand the range of services covered by federal insurance (ex. dental, vision, and hearing benefits)
• This would dramatically expand the demand for healthcare services, consistent with economics research findings that the more of an individual’s health costs are covered by insurance, the more services they tend to buy, irrespective of the services’ efficacy and value.

We Do Not Know How Much Medicare For All Would Disrupt the Availability and Quality of Health Services

This legislation would dramatically increase the demand for healthcare services while simultaneously cutting payments to doctors and hospitals by more than 40 percent, reducing payments to levels that are lower on average than providers’ current costs of providing care.

Blahous draws this obvious conclusion: “It cannot be known how much providers will react to these losses by reducing the availability of existing health services, the quality of such services, or both.”

Clearly, this would lead to an unknown number of healthcare providers leaving the profession, either by retirement or by switching to non-clinical aspects of medicine. This would undoubtedly lead to a huge shortage in healthcare providers – which would lead to long waiting times to receive healthcare. There is already a serious shortage of doctors in this country and such legislation would hugely exacerbate that problem.

In every other nation where socialized medicine systems have been implemented, these changes have led to the following:

• Long waiting times to receive healthcare treatment
• Restrictions by the government in what treatments are approved
• Poorer healthcare outcomes

The message could not be clearer – Medicare For All is unaffordable – economically and medically.