Donald W. Light

Beware of the Risks & Costs of Prescription Drugs

THE RISKS OF PRESCRIPTION DRUGS ($15, Columbia University Press) has short chapters for general readers and students about how drugs have become a leading cause of death, disorders, accidents, and hospitalizations.
Kindle or Nook Paperback $15.00 167 pages Hardcover $46.00


SEE KEY ARTICLES IN YELLOW ON RIGHT. Click to download

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PILLARS OF CURRENT PHARMACEUTICAL POLICY

1. "Most new drugs are 'life-saving' and must be rushed to patients who need them."

a. Most new drugs not for life-threatening conditions. Perhaps 10 percent.

b. Independent reviewers judge about 90% new drug products as little or no better against clinical measures of improvement or less harm. Consistent pattern for 40 yrs

c. Therefore about 1% new drugs would be “life-saving.” (10% x 10% = 1%)

d. Most R&D spent on developing minor variations. Most marketing spent on them.

e. Inverse Benefit Law of widespread marketing that dilutes benefits and proliferates risks of harms.


2. "The FDA screens out unsafe and ineffective drugs. Approved drugs are safe and effective."

a. Better than placebo means new drugs may be less effective than existing ones. No useful evidence for prescribing or how new drug compares to others.

b. Non-inferior means new drugs are no worse than -20% the comparator drug. No useful evidence on how superior new drugs are, if they are.

c. Evidence on risks of harms in minimal. From company trials designed to minimize evidence of harms.

d. All evidence on a carefully chosen, ideal population most likely to benefit and not have adverse reactions. Real patients and real patterns of use usually less beneficial and more harmful.

e. Since 90% of new drug products are little or no better, they cannot be safe.

f. Aside from in-class choice, are the FDA and EMA flooding the market with ineffective, unsafe drugs?


3. An epidemic of harmful side effects (with few offsetting benefits).

a. the 4th leading cause of death. About 113,000 deaths just in hospitalized patients.

b. About 2.5 million serious reactions and 1.7 million hospitalizations.

c. About 50 million adverse reactions, mostly mild but impair performance & judgment

d. A major cause of falls, accidents, anti-social behaviors.

e. Risks of harm increase through cascade effect and take multiple drugs.

f. Harmful side effects generate more sales.


4. Market is flooded with new drug products of little or no advantage that consume 80% of increased pharmaceutical costs. Harmful side effects generate more sales.

a. A self-reinforcing syndrome: high prices, protected by government from free market competition, fund the development of these drugs and their costly marketing, which generate more revenues to develop more of these drugs.


5. “US prices have to be high to recover $1.7 billion in R&D costs per new drug and recover what lower prices abroad do not recover.”

a. The $1.7 billion figure is inflated from unverifiable R&D costs which companies have strong incentives to inflate from the start. Half the “costs” are estimated profits that companies would have made if they had not invested in R&D for new products vital for their survival. Another half are costs subsidized by taxpayers. Then the $1.7 billion estimate is based on the most costly 20 percent of new drugs but attributed to all drugs – a three-fold distortion. Just these three factors mean you divide by 12 to get $0.14 billion. Another third of the total comes from backing in a high amount for the unknown cost of discovery. And there’s more… See “Demythologizing the high costs…”

b. The BMJ article “Foreign free riders…” drew on data from the National Science Foundation, companies and government to conclude that companies earn back all expenses and make a profit at Canadian and European prices. US high prices simply make extra profits from government protections from free-market competition.

c. The USA is the primary market where drug companies raise prices each year on last year’s models because they are protected from free-market competition.

d. Pharmaceutical companies will make solid profits under bundled payments that rein in high prices.

e. Cancer drugs should be relatively cheap. First, most R&D is paid for by others, not companies. Second, trials are smaller and shorter than for other drugs. Third, in most cases we have no verifiable evidence that manufacturing costs are higher. Why, then, are cancer drugs priced higher than statin drugs? Most cancer drugs cause serious harms and provide little additional benefit, with exceptions.



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Donald Light is a professor of comparative health care at the University of Medicine and Dentistry of New Jersey, School of Osteopathic Medicine. He is an economic and organizational sociologist who compares health care systems and analyzes health care policies. He has written about the history and dynamics of health care markets and health care insurance, countervailing powers, the medical profession, immigrants and health care, and global justice.

As a founding fellow of the Center for Bioethics, Light is concerned about the high prices of medicines and barriers to their access. His research aims to provide a demythologized, more realistic account of costs, relative effectiveness and harms, and innovation than is promoted by commercial interests and sponsored academics. He is concerned that current incentives, laws, and regulations encourage companies to develop many new drugs with few advantages, rather than focusing on really superior new drugs. In the long run, this does not serve the major companies or society well.




Selected Works

PHARMAMYTHS AND REALITIES
Companies are spiraling up high prices, not because of costs or better value, but because they can get away with it, only the USA.
Review of evidence that only 1 in 10 new drugs has substantial clinical advantages but 1 in every 5 results in serious harms.
Insights in to how drug companies have been transforming illness, diagnosis, the role of doctors, and treatment, away from clinical pathology to risks by numbers.
High prices and little added value characterize most new drugs. The industry turns out articles on the so-called innovation crisis but we prove there is none. Rather, a hidden business model leads to scores of minor variations.
A detailed account of extending data exclusivity without credible evidence it increases innovation. A costly protection from free-market competition
Recent record-high cost estimates of R&D are not only untrue but can impede policy for global health justice
Prescription drugs are less effective and more dangerous than patients or physicians think
Cost of research per new drug is much lower than claimed
How drug marketing undermines patient safety and public health
Provides evidence that research and other costs are recovered at European prices. Higher US drugs prices go largely to more marketing and profits.
Three Harvard professors violated nearly every standard when we questioned the Tufts-DiMasi high estimate of R&D costs.
While medical journal editors work hard to minimize commercial bias in research articles that can threaten their reputation and trustworthiness, editors need to consider commercial influences on themselves, like revenues from reprints of positive results and advertising. These could be significantly reduced.
The Foreign Free Rider claim is a myth. Dollar for dollar, Europeans have discovered more global new drugs than Americans
84% of all funds to discover new drugs comes from public sources
Costs much lower than claimed and recovered in 18 months; so price can be low & profitable.
GLOBAL JUSTICE AND VACCINES FOR THE POOR
Very brief description goes here
The pneumococcal AMC needs changes to avoid sinking GAVI
The only history of this global policy tool and why we need to use open design to do it better.
Two-thirds of $1.5 bn donated by taxpayers will go to extra profits rather than to saving poor children if the pneumococcal AMC is used
Advanced Market Commitments to encourage new vaccines for the poor are impractical, too expensive, and benefit the Big Four more than poor children

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