Included Studies And Characteristics
After elimination of duplicates, our search strategy identified a total of 1,498 studies. Initially, the eligibility of all articles was checked by reviewing the title and abstract of each study. This resulted in 29 studies, of which the full-text was assessed. Assessing the full text of these articles led to the exclusion of 19 additional articles. Exclusion of these additional articles was due to various reasons including: the study was not empirical , the study only focused on unilateral interaction, did not made a clear distinction between unilateral and bilateral interaction, or the study did not describe the interaction between pharmaceutical companies and healthcare providers in enough detail , the study focused on other stakeholders such as healthcare authorities , and the study only focused on the prevalence of relations between pharmaceutical companies and healthcare providers but not on their effect . As a result, a total of 10 empirical studies regarding the effects of bilateral interaction between pharmaceutical companies and healthcare providers were included in our review . The process of including and excluding articles is graphically represented by the PRISMA-diagram in Fig 1.
PRISMA flow diagram.
Big Pharma And Fda: A Marriage Not Made In Heaven
In this excerpt from the new book Crony Capitalism in America 2008-2012, Hunter Lewis exposes the incestuous relationship between government and the drug industry.Lewis, who serves as president of ANH-USAs board of directors, has written nine books on moral philosophy, psychology, and economics, including the widely acclaimed Are the Rich Necessary? . He has contributed to the New York Times, the Times of London, the Washington Post, and the Atlantic Monthly, as well as numerous websites such as Forbes.com and RealClearMarkets.com.In his new book, Lewis shows how private interests and politicians rely upon one anotherpolitical favors in exchange for moneya system known as crony capitalism. Where do private interests such as those on Wall Street or in the drug industry stop and Washington begins? Its impossible to say anymore.Chapter 15 is all about the FDA, and we thought our readers would enjoy this searing behind-the-scenes look at just how deeply the US Food and Drug Administration has enmeshed itself with the pharmaceutical industry:
Pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a companys drug.
President Trumps Broken Promises On Drug Pricing
In an interview with Time magazine ahead of being chosen as its Person of the Year in 2016, Trump said, Im going to bring down drug prices. I dont like whats happened with drug prices.50 He promised to bring Americans drug spending down to $0 by negotiating drug prices.51 Trump made grandiose promises on drug pricing but almost three years later has only managed to deliver a handful of half-measures, illustrating his administrations lack of commitment to lowering drug prices. One of Trumps proposals from his so-called presidential blueprint52 included eliminating some rebates paid by drug companies53 that hide the true cost of drugs. However, the Congressional Budget Office estimated that the measure would actually increase federal spending on Medicare and Medicaid by $177 billion.54 The Trump administration also announced a regulation that would require TV ads for drugs to include the list price.55 Some experts believe this policy will be ineffective56 at making pharmaceutical companies lower list prices or end price hikes for drugs and will only confuse or mislead consumers rather than help them.57 These half-measures, combined with Trump surrounding himself with high-level Big Pharma officials, clearly communicates that the administration is not on track to lower drug costs for Americans.
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Average Annual Approvals Of New Drugs By The Fda
Number of Drugs
From 2015 to 2019, the FDA approved about twice as many new drugs as it did a decade earlier. Biologic drugs make up a growing share of FDA approvals.
Data source: Congressional Budget Office, using data from the FDAs Center for Drug Evaluation and Research and the FDAs Center for Biologics Evaluation and Research. See www.cbo.gov/publication/57025#data.
Until the 1990s, the FDA did not count biologics as a separate category they were counted with NMEs.
BLA = biologic license application FDA = Food and Drug Administration NME = new molecular entity.
Information about the kinds of new drugs the pharmaceutical industry has introduced can be inferred from changes in retail spending across different therapeutic classes of drugs. When ranked by retail spending, therapeutic classes in which many expensive specialty drugs have been introduced over the past decade top the ranking, whereas classes in which the best-selling drugs are now available in generic form rank lower now than they did a decade ago.6 Information about the kindsof new drugs the pharmaceutical industry may introduce in the future can be inferred from clinical trials under way.
American Taxpayers Fund Basic Research
Billions of taxpayer dollars go into the creation and marketing16 of new drugs. The Los Angeles Times reports that, Since the 1930s, the National Institutes of Health has invested close to $90017 billion in the basic and applied research that formed both the pharmaceutical and biotechnology sectors. Despite taxpayers crucial investment, U.S. consumers are increasingly paying more for their prescription drugs.
A 2018 study18 on the National Institute of Healths financial contributions to new drug approvals found that the agency contributed to published research associated with every one of the 210 new drugs approved by the Food and Drug Administration from 20102016. More than $100 billion in NIH funding went toward research that contributed directly or indirectly to the 210 drugs approved during that six-year period. The NIH Research Project Grant 19which supports health-related researchwas by far the most common kind of grant used to fund the science that supported the new drugs. In all, NIH gave out nearly 118,00020 R01 grants related to those drugs from 2010 to 2016.
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Vaccine Mania: The Relationship Between Government And Pharmaceutical Companies
June 2, 2011 By admin
The vaccination question is a hotly debated topic, even in the natural health community. It doesnt help when vaccine companies have blatant conflicts of interest and the studies supporting their safety may be fraudulent!
What we all can agree upon is the need to keep crony capitalism out of it, to keep information clear, unambiguous, and uncensored, and to allow people to make informed choices for themselves and their families. As we noted last year, there is an increasing tendency for immunization mandates to become a financial joint venture of the vaccine manufacturer and the government. The government is providing much of the funding manufacturers need to build facilities. So the government, which is supposed to regulate vaccine makers, becomes a full financial and operating partner with the companies theyre regulating! The government then turns around and orders us to be vaccinated or be ineligible for schoolor in some cases go to jail!
As it stands now, the government gives patent protection and FDA approvals to pharmaceutical companies and thus creates medical monopolies. The government also exempts vaccine makers from legal liability. But when in addition the government invests in the business itself and partners with private companies, then adds the threat of jail for consumer non-compliance, we have a completely out-of-control situation.
What Are Recent Trends In Pharmaceutical R& d And New Drug Approvals
The pharmaceutical industry devoted $83 billion to R& D expenditures in 2019. Those expenditures covered a variety of activities, including discovering and testing new drugs, developing incremental innovations such as product extensions, and clinical testing for safety-monitoring or marketing purposes. That amount is about 10 times what the industry spent per year in the 1980s, after adjusting for the effects of inflation. The share of revenues that drug companies devote to R& D has also grown: On average, pharmaceutical companies spent about one-quarter of their revenues on R& D expenses in 2019, which is almost twice as large a share of revenues as they spent in 2000. That revenue share is larger than that for other knowledge-based industries, such as semiconductors, technology hardware, and software.
The number of new drugs approved each year has also grown over the past decade. On average, the Food and Drug Administration approved 38 new drugs per year from 2010 through 2019 , which is 60 percent more than the yearly average over the previous decade.
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Fast Forward To Present
In 2019, the stage is much the same. While pharmaceutical companies do get sued over the prescription drug addiction crisis, the lawsuits never accomplish as much as we want them to. Pharma companies might pay out millions in fines, but thats just pocket change for these multi-billion dollar companies.
And the lawsuits never enforce change. Fines are paid, and reparations are made, but none of the suits come to a close with a court order for sued pharma companies to Cease all production of the prescription drug you are being sued over. That would be a correct and fair ruling.
What are we going to do about this? In the 1990s it was the HIV/AIDS epidemic and Big Pharmas monopoly over HIV medicine. And now in the 2000s, it is the addiction epidemic, an epidemic fueled by pharmaceutical opioids and other habit-forming drugs.
The only way to reduce Big Pharmas influence over Congress and to reduce the addiction epidemic in the process is to simply stop using their products. Lawsuits help, but they will only ever take us so far. We have to take this crusade a step further.
Where Does Industry Invest
Annual industry expenditures on research have averaged less than 15 percent of sales and have less impact than that on profit because of the tax benefits associated with research spending. The industrys enormous profits are what remains after all of its research and marketing expenses which is why the industry is awash in cash.
Pfizer now holds $74 billion in unrepatriated profits overseas and Merck holds $60 billion enough to fund their respective annual research budgets for 10 years. Meanwhile, taxpayers are spending $30 billion a year on basic biomedical research the benefit from which flows to the pharmaceutical industry free of charge.
Under current law, ownership of the patents on drugs discovered with taxpayer money is given away to the academic institutions that discover them. They license those patents to the pharmaceutical industry in exchange for the payment of a royalty which the public actually pays since the royalty increases the price charged for a drug. Federal law essentially socializes the cost of drug discovery while privatizing the profits since it does nothing to limit the prices that can be charged or the profits that can be earned from drugs discovered at public expense.
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Canada Needs To Renew Its Relationship With Its Pharmaceutical Industry
Because of COVID-19, countries around the world have recognized the contribution that a strong life sciences sector makes to the health and well-being of their citizens and their economies. Canada is no different. Our countrys economic future will be driven by a robust life sciences sector with companies working at the forefront of knowledge and technology, and driving economic growth through significant investments in research and innovation. The life sciences sector includes all science and technology-based products and services applied to human health, as well as certain segments of the animal health industry. The major industry segments are pharmaceuticals, medical devices and laboratory instruments, health information technology, natural health products and health-care services.
However, we have also learned another, harder truth here in Canada: the relationship between the federal government and the countrys innovative pharmaceutical industry is fractured. That poses a challenge to the life sciences in Canada and creates risks for our economy and our health.
I highlight this to illustrate an important point. The pharmaceutical industry is a global one and, as in many other international industries, companies make decisions about where to invest based on a range of factors, including the ability to access top talent, the regulatory environment and a host of other factors related to the ease of doing business.
$345 Billion Over 10 Years
The CBO did an evaluation of HR 3 and concluded it would significantly cut prices for drugs in the U.S. and index those to prices in other countries, said Dusetzina. That estimate has us saving approximately $345 billion over 10 years at the cost of losing the development of eight to 15 new drugs in the same period when about 300 new drugs would be developed.
Thats a pretty huge amount of money and a pretty small number of drugs but it depends on what those lost drugs are. If you lose a drug that made a substantial improvement for someone with a rare type of cancer, that would be a significant loss to society, Dusetzina said. Or do we revise how we pay for drugs in a way that considers the value of those drugs and rewards the right types of innovation? The best-case scenario would be to lose the innovation in areas where were not getting very many gains and were still seeing high prices.
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Average R& d Intensities For Publicly Traded Us Companies By Industry
Pharmaceutical companies have devoted a growing share of their net revenues to R& D activities, averaging about 19 percent over the past two decades. By comparison, other research-intensive industries, like software and semiconductors, averaged about 15 percent.
Data source: Congressional Budget Office, using data from Bloomberg, limited to U.S. firms as identified by Aswath Damodaran, Data: Breakdown , . See www.cbo.gov/publication/57025#data.
R& D intensity is research and development spending as a share of net revenues .
R& D = research and development S& P = Standard and Poors.
There are several possible explanations for the increase in the industrys R& D intensity over the past eight years. It could reflect the increased role of small drug companies, which have little revenue and, therefore, high ratios of R& D spending to net revenues. It could also indicate that the expected returns from investments in R& D have increased or that opportunities to develop new drugs have increased . Finally, it could reflect rising costs of R& D inputs, such as capital equipment and skilled labor. CBO has not evaluated the relative importance of those possibilities.
As In The Past Pharma Leans Towards Republicans Over Democrats
In 14 of the past 16 elections, dating to 1990, pharmaceutical industry PACs have given more money to Republicans than to Democrats.
This cycle is no exception: So far in 2020, according to STATs analysis, 53.5% of drug industry PAC donations to lawmakers or groups affiliated with a political party have gone to Republicans, while 46.6% have gone to Democrats.
The difference is more stark at the leadership level. House Minority Leader Kevin McCarthy got $129,000 in drug industry campaign cash. House Speaker Nancy Pelosi , meanwhile, received just $11,000.
And while McConnells $197,386 make him the leading recipient of industry PAC contributions, according to STATs analysis, Senate Minority Leader Chuck Schumer has accepted only $77,500 from drug makers to date.
Though drug industry PACs most commonly wrote checks to high-profile lawmakers like McConnell or Schumer, many also targeted comparatively rank-and-file members of Congress of both parties.
Rep. Brett Guthrie , who holds a coveted seat on the House Energy and Commerce Committees oversight panel, has accepted $108,147 from drug industry groups so far this cycle. Rep. Kurt Schrader , who also sits on the Energy and Commerce Committee, was a leading recipient among Democrats with $86,000.
A Biden presidency, given his sweeping drug pricing platform, would only add to the industrys woes.
Even among GOP ranks, however, there is little that leading drug industry figures can count on.
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Smithkline & French Pharmaceuticals
In the Organic Chemistry Section of SmithKline & French Laboratories, Wilfred H. Lindell, professor of pharmaceutical chemistry of the University of London, England, , examines the yield of a new pharmaceutical with Maurice L. Moore, director of the Research Laboratories of SKF , and Glenn E. Ullyot, director of organic chemistry . Lindell was on a four-week scientific visit to the United States as a guest of SmithKline & French.
Science History Institute
Over the past two years the U.S. Food and Drug Administration and Congress have sought to break the pharmaceutical industrys influence over the regulatory system. In August 2008 the FDA enacted new rules barring researchers from serving on its advisory committees if they receive more than $50,000 either from a company whose product is being discussed or from that companys competitors. And in the fall of 2007 the Senate and House passed bills that restrict the number of conflict-of-interest waivers permitted on each FDA advisory committee. These waivers allow experts with otherwise disqualifying financial interest to serve on an FDA advisory committee.
Academics are also concerned about their relationships with drug companies. In April 2008 the New York Times reported that some prominent academic researchers, troubled by ethical conflicts, have decided to stop accepting payments from drug companies.
How Big Pharma Profited From The Pandemic L Opinion
The U.S. government cleared the way for the big pharmaceutical firms to develop vaccines, and several made a lot of money doing it. Drug firms also raised prices on other products.
And the companies deserve credit for the vaccines. But make no mistake: The effort by drug companies was hugely profitable, because the government paid for the research, removed all the risk factors and committed billions to pre-approval purchases.
According to a study in the leading journal Health Affairs, The government essentially removed the bulk of traditional industry risks related to vaccine development: a) scientific failures, b) failures to demonstrate safety and efficacy, c) manufacturing risks and d) market risks related to low demand.
The federal government spent between $18 billion and $23 billion to develop all the COVID vaccines, various estimates show. The studys authors found that amount was given on top of years of government-funded vaccine research that set the platforms for the current successes.
In the case of Moderna, federal agencies funded 100% of the $2.5 billion it spent developing its COVID vaccine.
And this year, Pfizer forecast it will receive $54 billion revenue from its COVID vaccine and treatment, a sum larger than the combined revenue for all its other products.
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