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<ul class="summary-list"><li>Thirty-six percent of older Americans can't afford one year of basic <keyword id="12243971" type="UNKNOWN" weightage="60" keywordseo="elder-care" source="Orion">elder care</keyword>, a Boston College study found.</li><li>The share is higher for uneducated Americans, racial minorities, and unmarried women.</li><li>The findings paint a bleak picture for the millions who retired early due to the COVID crisis.</li></ul>Americans are retiring earlier than ever, but many won't be financially prepared.Some exited the workforce during the pandemic because <a href="https://www.businessinsider.com/record-americans-millionaires-401k-ira-retirement-accounts-fidelity-stock-market-2021-8">soaring stocks boosted their retirement savings</a>. Some <a href="https://www.businessinsider.com/3-things-labor-shortage-people-quitting-work-afl-cio-spriggs-2021-7">retired early</a> because they lost their jobs and struggled to find new work. And as virus cases remain at elevated levels, some are just too worried about the pandemic to keep working.Yet a <a href="https://crr.bc.edu/briefs/what-resources-do-retirees-have-for-long-term-services-supports/">recent study</a> from Boston College suggests a large share of retirees can't really afford it.Americans' odds of retiring before 62 <a href="https://www.businessinsider.com/new-retirement-age-labor-market-great-resignation-boomers-golden-decade-2021-9">rose to roughly 50% in July</a>, according to a survey from the Federal Reserve Bank of New York. That's the highest reading dating back to 2014 and caps a steady decline in <keyword id="11909870" type="UNKNOWN" weightage="60" keywordseo="retirement" source="Orion">retirement</keyword> age over the last several years.But 36% of Americans aged 65 to 69 aren't able to cover just one year of minimal care, according to the<a href="https://crr.bc.edu/briefs/what-resources-do-retirees-have-for-long-term-services-supports/"> study</a> from Boston College's Center for Retirement Research. Only 21% of Americans can cover a year of severe needs, such as dementia or physically debilitating health issues.The team's calculations include the need for paid and unpaid care. It also uses the median hourly rate for a home health aide for paid-care calculations, which totaled $22 per hour in 2018.The ability to pay for <keyword id="12243967" type="UNKNOWN" weightage="60" keywordseo="elderly-care" source="Orion">elderly care</keyword> also varies widely depending on marital status, education, and race and ethnicity, researchers Anek Belbase, Anqi Chen, and Alicia Munnell said in the September paper. While 31% of married people aren't able to cover a year of care, the share climbs to 33% for unmarried men and 56% for unmarried women.College graduates are also much more prepared to cover care costs than less-educated Americans. Just 14% of people with college degrees can't afford a year of minimal care, according to the study. Conversely, 65% of those who never graduated high school don't have the means to pay for care.And white Americans are generally much better equipped for retirement than racial minorities. Just 32% of white Americans can't cover minimal elderly care, according to the study. That jumps to 49% for Black Americans and doubles to 64% for Hispanic Americans.The findings paint a bleaker picture of retirement at a time when millions of Americans - many unwillingly - have yet to return to the workforce. The labor force participation rate for Americans aged at least 55 years <a href="https://www.businessinsider.com/3-things-labor-shortage-people-quitting-work-afl-cio-spriggs-2021-7">sits near 15 year lows</a> after tumbling at the start of the pandemic, while the broader rate has staged a much more significant recovery. The data, along with booming retirement accounts, suggest many Americans were forced into early retirement due to the pandemic.Many of those who haven't retired yet have done little to prepare. Twenty-six percent of non-retired Americans <a href="https://www.businessinsider.com/personal-finance/quarter-of-americans-have-no-retirement-savings-2019-6">haven't saved a penny</a> for their eventual exits from the workforce, according to a 2019 Fed study. That means a significant number of Americans didn't benefit from the stock market's boom through the pandemic recovery, and are likely to have little financial cushion if any by the time they retire.With the pandemic now in its 19th month and <a href="https://www.businessinsider.com/jobs-report-august-235000-payrolls-unemployment-rate-labor-market-recovery-2021-9">the hiring recovery running on fumes</a>, people who left the workforce are unlikely to come back. The country may still be rebounding, but the new study suggests millions of old Americans are entering a new phase of economic turmoil.

Americans expect to retire earlier than ever, but nearly 40% of retirees can't afford to take care of themselves for just one year

<ul><li>Stock market investors are expecting a balanced <keyword id="6358021" type="General" weightage="100" keywordseo="budget" source="Orion">Budget</keyword> with a focus on job creation, and increased spending on infrastructure.</li><li><keyword id="464286" type="General" weightage="50" keywordseo="narendra-solanki" source="Orion">Narendra Solanki</keyword>, Head- Equity Research Anand Rathi Shares &amp; Stock Brokers, said that investors are expected to remain focused on three key factors from the pre-election year <keyword id="12743893" type="General" weightage="20" keywordseo="budget-2023" source="Orion">Budget 2023</keyword>.</li><li>History suggests India's shares are likely to see muted trading ahead of the union budget reading, usually held on February 1.</li></ul>Stock market investors are expecting a balanced Budget with a focus on job creation, increased spending on infrastructure, reigning in the deficit, and bringing the economy back on track, experts said on Wednesday. Stock markets have been subdued in the run-up to the Union Budget with BSE's benchmark Sensex is almost flat so far this month. Even the corporate earning season failed to excite the markets, while some indices like IT and bankex have seen some positive movements. The muted performance of the markets could be due to Foreign Portfolio Investors (FPIs) moving funds out of India as they are looking for emerging markets with cheaper valuations. They have taken out over Rs 16,500 crore from domestic equities so far this month. Moreover, inflation and possible global recession continue to play on investors' minds. Narendra Solanki, Head- Equity Research Anand Rathi Shares &amp; Stock Brokers, said that investors are expected to remain focused on three key factors from the pre-election year Budget 2023, firstly equity investors are expecting a uniform tax structure for capital gains which might help taxpayers to have more disposable income. Secondly, investors will be looking for fiscal consolidation which is necessary for financial stability in the economy and thirdly, investors are contemplating policy reforms to rationalise bottlenecks for growth such as subsidies, a clear roadmap for disinvestment targets and expediting the much-awaited PSU privatisation or consolidation, he added. History suggests India's shares are likely to see muted trading ahead of the union budget reading, usually held on February 1. Overall, the pre-budget rallies were seen in six out of the last 10 years, and post-budget, the market declined six times out of the past 10 years. Moreover, the National Stock Exchange's (NSE) benchmark index Nifty 50 has fallen seven times on Budget days. The Budget is a presentation of the state of affairs of the government's books along with anticipated expenses and income for the coming year. It is generally believed that if a Budget includes measures that are seen as positive for businesses and the overall economy, it may have a positive impact on stock markets. On the other hand, if a Budget includes steps that are seen as negative for businesses and the economy, it may have a negative impact on stock markets. Additionally, announcements or changes in interest rates, taxes and government spending can also impact stock markets. "The impact of the <keyword id="2407175" type="General" weightage="20" keywordseo="upcoming-budget" source="Orion">upcoming Budget</keyword> would depend on the actual budget proposal and markets will be keenly watching the fiscal deficit for FY24. A figure above 6 per cent will disappoint the market. But, this is unlikely," VK Vijayakumar, Chief Investment Strategist at Geojit Financial Services, said. He further said that a proposal that can have a negative impact on the market can be a possible hike in the capital gains tax. Any positive news which will have a meaningful impact on the economy or leave more disposable income in the hands of the salaried class and/or the corporates will push the markets higher, Sumit Chanda, Founder and CEO, JARVIS Invest, said. "Any changes to the tax slab of the salaried class or any incentive to the corporates for capex or reduced taxes will be viewed positively and one can expect the markets to rally post the Budget," he added. In addition, push to private and government spending, disinvestment, expanding the PLI (Product-linked incentive) scheme and relief in tax slabs are some of the measures that may have a positive impact on the market, Kamlesh Shah, President, ANMI, said. Geojit's Vijayakumar believes that the impact of the Budget will be short-lived. Market trends would be dictated more by developments in the global economy, particularly in the US. If the Fed commentary after the February 1 meeting is dovish and data shows inflation declining in the US, markets will rally. Amar Ambani, Head - Institutional Equities, Yes Securities, said the government is likely to be modest in its asset monetization targets, unlike the lofty projections of the prior Budgets. In all probability, India's GDP growth target would be a low double-digit affair amid a challenging global backdrop, and the government would not stray from its fiscal prudence roadmap. According to market experts, healthcare, fertilizer, infrastructure, defence insurance, manufacturing, digitalisation (IT), communication, education, Small and Medium Enterprises (SMEs) etc are sectors that are expected to benefit from the Budget. SEE ALSO: <a href="https://www.businessinsider.in/science/space/news/nasa-collaborates-with-spinlaunch-to-test-an-innovative-mass-accelerator-launch-system/articleshow/90772382.cms">NASA collaborates with SpinLaunch to test an innovative mass accelerator launch system — a slingshot to send payloads to space</a> <a href="https://www.businessinsider.in/science/space/news/astronomers-may-have-just-found-the-most-distant-astronomical-object-ever-observed/articleshow/90703688.cms">Astronomers may have just found the most distant astronomical object ever observed</a>

Stock market investors expect balanced budget, focus on job creation, infra spending

Hidden investors took over Corizon Health, a leading prison healthcare company. Then they deployed the Texas Two-Step.

Earlier this week, the Indian <keyword id="6355302" type="General" weightage="100" keywordseo="rupee" source="Orion">rupee</keyword> nosedived 51 paise, <a href="https://www.businessinsider.in/finance/news/rupee-hits-all-time-low-of-77-42-against-us-dollar/articleshow/91439581.cms">hitting an all-time low</a> of ₹77.41 against the US dollar. <div type="image" title="Rupee hit a lifetime low of 77.41 earlier this week" msid="91525914" hostid="261" caption="&amp;lt;p&amp;gt;Rupee hit a lifetime low of 77.41 earlier this week&amp;lt;/p&amp;gt;"></div> Earlier last week, the Indian rupee had appreciated eight paise after India’s central bank, the <keyword id="6354335" type="General" weightage="50" keywordseo="reserve-bank-of-india" source="Orion">Reserve Bank of India</keyword>, <a href="https://www.businessinsider.in/finance/banks/news/rbi-hikes-repo-rate-by-40-basis-points-to-4-4-as-it-seeks-to-reign-in-inflation/articleshow/91311941.cms">increased interest rates</a> by 40 basis points on May 04, only to tumble further below this week. 100 basis points make one percent. The rupee has been staggering since the beginning of the year. <div type="image" title="Rupee depreciation in last one month" msid="91525962" hostid="261" caption="&amp;lt;p&amp;gt;Rupee depreciation in last one month&amp;lt;/p&amp;gt;"></div> This depreciating rupee, which is a fall in the value of a currency in terms of its exchange rate versus other currencies, is likely to have a direct impact on your daily expenditure. Imports now more expensive, while exports are cheaper With a small dip in the <keyword id="50739" type="General" weightage="20" keywordseo="indian-currency" source="Orion">Indian currency</keyword>, the Indian government has to pay a little extra for the same goods it was importing earlier. So, importing items get more expensive. Oil imports will get costlier, which has a direct impact on prices of many other things – anything that needs to be transported will (if it hasn’t, already) now see an increase in its prices. India currently imports <a href="https://www.businessinsider.in/finance/news/crude-oil-surges-significantly-to-109-per-barrel-as-countries-look-for-options-other-than-russia/articleshow/89936843.cms">85% of its oil demand </a>and the rise in crude oil prices directly increases import bill and expenses. Your investment portfolio is likely to be affected If foreign investors pull out of Indian equities, Indian currency depreciates, leading to a sharp decline in equity markets. Foreign investors have already <a href="https://www.businessinsider.in/stock-market/news/foreign-investors-have-pulled-out-1-5-lakh-crore-from-the-indian-markets-in-2022-so-far-heres-why/articleshow/91485411.cms">pulled out over ₹6,400 crore</a> from the Indian equity markets in the first four trading sessions of May when the Reserve Bank of India (RBI) and <a href="https://www.theguardian.com/business/federal-reserve">US Federal Reserve</a> raised interest rates. Given the headwinds in terms of elevated crude oil prices, inflation, and monetary tightening (also known as Quantitative Tightening), market volatility is expected to remain high as foreign investors could continue to withdraw funds. Foreign education could get more expensive If you are planning to study abroad, you might have to restructure your budget. You will have to shell out more rupees for every dollar you spend. Simply put, you will have to spend over 21% more in terms of rupee to buy the same number of dollars. If you budgeted ₹20 lakh for your education abroad, you will now have to increase it to ₹24.2 lakh. <div type="image" title="Foreign education will get more expensive" msid="91525979" hostid="261" caption="&amp;lt;p&amp;gt;Foreign education will get more expensive&amp;lt;/p&amp;gt;"></div> International travel now more expensive During summer, the travel sentiment is high among consumers. As the rupee loses value against the US dollar, your plans to travel abroad will burn a deeper hole in your pocket – like everything, paying for your purchases in foreign currency, moreso the US dollar, is now more expensive than ever before. A weaker rupee results in expensive imports, and contributes to inflation <a href="https://www.livemint.com/economy/indias-inflation-likely-accelerated-to-18-month-high-in-april-poll-11652181052993.html">India's retail inflation</a> surged to an 18-month high in April, largely driven by rising fuel and food prices and staying well above the RBI's upper tolerance limit for a fourth consecutive month, a Reuters poll found. As the rupee weakens against the dollar and import prices hike, companies may not be able to absorb this increase in cost and may pass it on to consumers. Increase in your home loan EMIs and more To keep inflation in check, RBI resorts to increasing its interest rates. If the RBI expects that inflation will rise beyond its tolerance limit, it hikes the rate at which banks borrow money from the RBI, which is also known as the repo rate. When repo rate increases, the cost of borrowing for banks also increases, which is passed to their account holders by increasing the interest rate on loans and deposit rates. Some banks have already announced an increase in interest rates on home loans – HDFC has <a href="https://economictimes.indiatimes.com/wealth/borrow/hdfc-hikes-home-loan-interest-rates-this-is-how-much-your-emi-will-go-up-by/articleshow/91434723.cms">increased</a> its interest rates for retail home loans by 30 basis points, with the new rates now in the range of 7-7.45%. But what has caused the decline of the Indian rupee? The value of any currency depends on its demand in the market. If the demand increases, its value goes up, which is known as appreciation. And if the demand for a currency declines, its value depreciates. If more foreign investors invest in Indian businesses and projects, the demand for Indian currency goes up. To be able to invest in India, foreign companies have to first convert their currency into Indian rupees. This increase in demand for the rupee strengthens its value against the US dollar. Recently, more and more overseas investors have pulled out a big chunk of their money from the Indian market, consequently <a href="https://www.businessinsider.in/stock-market/news/the-stock-markets-are-going-through-a-short-term-correction-and-now-might-be-a-good-time-to-invest-in-valued-stocks-say-analysts/articleshow/91369077.cms">affecting market sentiment</a> and currency’s decline. <div type="image" title="Foreign investors have pulled out `1.5 lk cr in 2022 so far" msid="91526033" hostid="261" caption="&amp;lt;p&amp;gt;Foreign investors have pulled out `1.5 lk cr in 2022 so far&amp;lt;/p&amp;gt;"></div> The <a href="https://www.theguardian.com/business/federal-reserve">Federal Reserve</a> has raised interest rates for the first time since 2018, as the US central bank struggles with soaring inflation, the impact of the war in Ukraine and the COVID crisis. As interest rates soar, investors start pulling money out of riskier investments like equities, commodities and foreign markets. The annual <a href="https://www.businessinsider.in/policy/economy/news/inflation-slowed-in-april-for-the-first-time-in-8-months/articleshow/91496347.cms">inflation rate in the US</a> is now at 8.3%, which also affects market sentiment. Here’s an <a href="https://youtu.be/eADkfR1PUeU">explainer by Stocktwits India </a>on how the global inflation rate affects India and what the government is doing to combat it. Therefore, foreign investors are exiting their investments in India, and shoring up their investments in the relatively safer markets in the US. On the other hand, when Indian businesses and companies import foreign goods and products, such as crude oil, gold, consumer electronics, among other things, they convert their rupees into dollars, which is the global currency for international trades. If imports exceed exports, demand for the dollar goes up and the rupee weakens against it. Since India has been a <a href="https://www.indiatoday.in/news-analysis/story/current-account-surplus-india-net-exporter-explainer-1705281-2020-07-28">net importer</a>, we import more than we export, the rupee has gradually depreciated over time. <div type="image" title="Rupee vs Dollar in the last five years" msid="91526067" hostid="261" caption="&amp;lt;p&amp;gt;Rupee vs Dollar in the last five years&amp;lt;/p&amp;gt;"></div> As the upward trend of the graph shows, you had to shell out ₹64 in May 2017 for 1 US dollar. Today, you have to pay ₹77.26 in exchange for a dollar. To deal with this <keyword id="688216" type="General" weightage="20" keywordseo="Rupee-depreciation" source="Orion">rupee depreciation</keyword>, you can reevaluate your investment portfolio and consider companies that have a substantial amount of foreign exchange earnings such as in sectors like pharma, FMCG, and IT. Here's a short video <div type="image" title="Here&amp;#39;s what happens when the Rupee depreciates" msid="91526220" hostid="261" caption="&amp;lt;p&amp;gt;Here&amp;#39;s what happens when the Rupee depreciates&amp;lt;/p&amp;gt;"></div> Disclaimer: This is not investment advice, it is for informational purposes only.

SIMPLY PUT: Why is the rupee falling and how it affects your food, education, healthcare and other expenses

<ul class="summary-list"><li>The agency's approval of a new <keyword id="24487" type="PERSON" weightage="60" keywordseo="Alzheimers">Alzheimer's</keyword> drug rightly caused an uproar.</li><li>But the problems extend far beyond the drug, and far beyond the <keyword id="6354656" type="ORGANIZATION" weightage="60" keywordseo="fda">FDA</keyword>: Drug <keyword id="41551" type="ENTERTAINMENT" weightage="60" keywordseo="science">science</keyword> has been corrupted by the pharmaceutical industry. </li><li>We must get money out of science to have safe and effective drugs.</li><li>P.E. Moskowitz is an author and runs Mental Hellth, a newsletter about capitalism and psychology.</li><li>This is an <keyword id="6356002" type="UNKNOWN" weightage="100" keywordseo="opinion">opinion</keyword> article. The thoughts expressed are those of the author. </li></ul>Earlier this month, three scientists on an independent panel at the Food and Drug Administration (FDA) <a href="https://www.businessinsider.com/third-member-of-fda-panel-resigns-over-approval-of-alzheimers-drug">resigned</a> after the agency green-lit a drug that the scientists had recommended against approving. The drug, aducanumab, brand name Aduhelm, is designed to help Alzheimer's patients, but there's <a href="https://www.businessinsider.com/biogen-new-alzheimers-drug-aduhelm-criticism-testing-better-drugs-2021-6">little evidence that it actually works</a>, and monthly infusions of it cost $56,000 a year."This might be the worst approval decision that the FDA has made," Aaron Kesselheim, one of the resigned panelists, <a href="https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html">told The New York Times</a>. No one on the <a href="https://www.businessinsider.com/fda-expert-panel-recommends-against-biogen-alzheimers-drug-candidate-2020-11">11-member panel agreed</a> with drug maker Biogen's claim that the drug could help with cognitive decline in early Alzheimer's patients, but the FDA approved the drug anyway. It will now be shipped to over 900 clinics, according to the New York Times, and within a few weeks, will be used on patients, prompting government watchdog group Public Citizen to issue a rare call that top FDA officials resign. "The primary beneficiaries of the agency's action are Biogen and its shareholders, who undoubtedly are ecstatic about their soon-to-be-reaped windfall profits from sales of the company's exorbitantly priced but ineffective drug," Michael Carome, the director of the Public Citizen's health research group wrote in <a href="https://www.citizen.org/wp-content/uploads/2590.pdf?eType=EmailBlastContent&amp;eId=71e193ec-6879-407a-bea6-e88ea51fdfd5dfd5">a scathing 8-page letter to the FDA</a>.One of the biggest problems with the drug is its cost: If just one in six Alzheimer's patients receive the drug, it <a href="https://welch.house.gov/sites/welch.house.gov/files/Letter%20to%20Biogen%206.15.21.pdf">could cost the US Medicare program $56 billion</a>, more than the entire 2019 budget of the agency. About 5.6 million Americans had Alzheimer's in 2020, but that number is <a href="https://www.cdc.gov/aging/aginginfo/alzheimers.htm#:~:text=In%202020%2C%20an%20estimated%205.8,or%20older%20had%20Alzheimer's%20disease.&amp;text=1-,This%20number%20is%20projected%20to%20nearly,14%20million%20people%20by%202060.%202060.">expected to balloon to 14 million by 2060</a>. Tax payers would be footing a massive bill for an ineffective drug.The approval of Aduhelm is a particularly egregious example of how the FDA flaunts actual science in favor of pharmaceutical industry-friendly approvals. But focusing on this one approval as an isolated event is a mistake. Instead, it's part of a troubling pattern at a fundamentally flawed agency - the FDA is structured and funded in a way that helps prescription drug companies more than it helps or protects the public - and a sign of a much larger problem: The way medicinal science is funded and rubber-stamped in this country has less to do with public health than it does with profit. Until there is a vast overhaul of our scientific funding and approval pipeline, there are sure to be countless instances like Aduhelm, in which drugs are foisted on the public without much benefit - except to the shareholders of drug companies.<h2>One foot in the FDA, one foot in the pharma industry </h2>The current FDA commissioner Janet Woodcock has been <a href="https://childrenshealthdefense.org/defender/janet-woodcock-wrong-person-lead-fda/">accused of having improper relationships with drug companies in the past</a>. Likewise, the former director of the FDA, Dr. Scott Gottlieb, <a href="https://www.citizen.org/article/outrage-of-the-month-revolving-door-to-fda-commissioners-office-sows-distrust-in-agency/">has deep ties</a> to pharmaceutical companies.But lower down the FDA food chain, the conflicts of interest get even more severe. FDA scientists who shepherd a drug through the approvals process are commonly later given jobs at the companies whose drugs they helped approve. Over 50% of drug reviewers at the FDA eventually take positions in the pharmaceutical industry, according to the <a href="https://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry">limited research available</a>. Thomas Laughren, for example, once the agency's director of psychiatric products, <a href="https://www.sciencemag.org/news/2018/07/fda-s-revolving-door-companies-often-hire-agency-staffers-who-managed-their-successful">dismissed evidence that antipsychotics could cause sudden cardiac death</a>, and supported the use of the drugs for a wider range of mental disorders than they were originally intended. After leaving the FDA, he began a consultancy to help drug companies get their drugs approved. He's <a href="https://www.globenewswire.com/en/news-release/2021/04/08/2206657/0/en/Former-FDA-Psychiatry-Division-Director-Dr-Thomas-Laughren-Joins-BetterLife-as-Regulatory-Advisor.html">now the regulatory advisor</a> for a company trying to get psychedelics approved by the FDA for mental illness treatment. Though there are anti-revolving-door rules on the books to theoretically prevent this exchange between industry and the FDA, they don't have enough teeth to actually stop it - and a recently-proposed law that would <a href="https://oversight.house.gov/news/press-releases/reps-gomez-and-maloney-reintroduce-executive-branch-conflict-of-interest-act#:~:text=The%20Executive%20Branch%20Conflict%20of%20Interest%20Act%20is%20included%20in,back%20to%20the%20American%20people.">attempt to partially fix this problem</a> has stalled in Congress.<h2>Questionable approval history</h2>Based on the agency's history, it is clear that the FDA has a pattern of approving drugs that show little to no efficacy, especially for <keyword id="6354774" type="ORGANIZATION" weightage="60" keywordseo="Mental-health">mental health</keyword> medications. Some of the <a href="https://journalnow.com/more-than-37-million-americans-take-antidepressants-authors-say/article_36f2f74b-e268-5731-bdc0-d92a036d2cd4.html">most popular medications in the world right now</a> are <keyword id="2525434" type="ORGANIZATION" weightage="60" keywordseo="SSRI">SSRI</keyword>s - antidepressants that theoretically work by preventing the brain from reabsorbing serotonin, and thus increasing serotonin levels in the brain. But clinical trials of these drugs have shown limited results. The first popular SSRI, Prozac (fluoxetine), for example, was built on shaky science. Its manufacturer Eli Lilly was <a href="https://khn.org/morning-breakout/dr00027432/">found to have hidden data</a> that suggested the drug could cause extreme agitation in patients, and data that showed that it could increase the risk of suicide. The FDA approved it anyway.Another blockbuster SSRI, Zoloft (sertraline), was also approved with limited scientific proof that it worked. Of the six studies Pfizer conducted on the drug, four of them showed that Zoloft did not beat placebo in helping depressed patients. Only one of the studies gave sertraline a positive result. The FDA approved the drug anyway. Study after study has suggested that antidepressants <a href="https://www.medicalnewstoday.com/articles/325767">may be no more effective than placebo</a>. Now, <a href="https://www.apa.org/monitor/2017/11/numbers">nearly 13% of Americans take SSRIs</a>, and that number has <a href="https://pharmaceutical-journal.com/article/news/antidepressant-prescribing-up-6-since-2019">likely spiked even higher since the pandemic</a>. Antidepressants are predicted to make drug companies <a href="https://www.prnewswire.com/news-releases/antidepressant-drugs-market-to-reach-15-98-bn-by-2023-globally-at-2-1-cagr-says-allied-market-research-873540700.html">$16 billion a year by 2023</a>. Though the faulty data on SSRIs doesn't mean they're ineffective for every patient - SSRIs not beating placebo could still mean they are working for some in the non-placebo group - it likely means they're overprescribed and that patients haven't been warned adequately of their myriad, often very serious side effects and <a href="https://www.nytimes.com/2018/04/07/health/antidepressants-withdrawal-prozac-cymbalta.html#:~:text=Patients%20who%20try%20to%20stop,so%20because%20of%20these%20symptoms.">the severe effects of discontinuing them</a>. The FDA relying on the faulty science of prescription drug companies, instead of doing their own tests, means that countless Americans are experimenting with medications that may not work for them, or could cause harm. <h2>Misplaced incentives</h2>The problem extends far beyond SSRIs. According to one <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2282014">2013 analysis</a>, a whopping 90% of new drugs approved by the FDA in the previous 30 years <a href="https://ethics.harvard.edu/blog/risky-drugs-why-fda-cannot-be-trusted">are little or no more effective</a> than existing drugs. How can the FDA be so bad at its job that 90% of drugs it approves are unnecessary? It's not a matter of a few, corrupt apples at the agency; it's a systemic issue about how science is approved, funded, and ushered through to the market in the United States. Over the last several decades, the amount of money spent by the US government on drug research <a href="https://www.ncbi.nlm.nih.gov/books/NBK50972/">has stalled</a>. Meanwhile, the amount spent by pharmaceutical companies on research <a href="http://compbio.ucdenver.edu/hunter/cpbs7605/whence%20the%20money.html">has skyrocketed</a>. The industry now spends about <a href="https://www.cbo.gov/publication/57126">$83 billion on research and development</a>, a tenfold increase since the 1980s. <a href="https://www.drugwatch.com/featured/clinical-trials-and-hidden-data/">In one analysis of the New England Journal of Medicine</a>, it was found that 60 of the 73 published drug studies were funded by the pharmaceutical industry, 50 studies included authors who were also employees of the industry, and 37 had accepted money from drug companies. This means that the impetus for much scientific research these days is not whether a new drug or product will be good for the public, but whether it will make money. One 2010 analysis, written about by Ben Goldacre in the book "<a href="https://us.macmillan.com/books/9780865478060">Bad Pharma</a><a href="https://www.goodreads.com/book/show/15795155-bad-pharma">"</a>, found that 85% of drug trials produced by the industry gave positive results, whereas only 50% of government-funded studies did.Drug trials themselves are biased toward profit-making. Drug companies routinely quash studies that show their new drugs to be less effective than old ones, and <a href="https://www.drugwatch.com/featured/clinical-trials-and-hidden-data/">design the trials to skew results toward positive outcomes</a>. As detailed in "Bad Pharma", analyses show that most research demonstrating SSRIs to be ineffective is simply never published - of 74 studies on antidepressants published between 1987 and 2004, 38 showed the drugs were effective, and 36 showed they were not. All but one of the 38 positive studies was published in a scientific journal, but only three of the negative ones were. The problem with Aduhelm, as it's been presented in the mainstream media, is of one particularly egregious FDA approval, but reporting and analysis of this scandal misses a much larger and more dangerous reality: The corruption of science in the US is endemic to the way science is funded. The solution to this bad science will be hard to come by because the problem runs so deep. Schools that conduct scientific research have had their federal aid decreased, and <a href="https://www.aaas.org/programs/r-d-budget-and-policy/rd-colleges-and-universities">drug companies now fund a larger share of their budgets</a>. Government austerity for science is the norm, whether under Democratic or Republican administrations. And nothing is likely to change when the biggest lobbying group year over year is not Big Oil or Big Tech, but <a href="https://www.opensecrets.org/federal-lobbying/industries">Big Pharma</a>.The FDA may be filled with well-intentioned scientists who care about public health, but that does not matter as long as the structural issues remain. No matter who leads the agency - as long as it derives some of its budget from prescription drug companies, and as long as it relies mostly on the science of drug companies rather than science untainted by the profit motive (whether performed by the government, non-profits, or universities) - it will remain a fundamentally flawed agency.The end of corrupt science can only come when we get money out of <keyword id="6358883" type="UNKNOWN" weightage="60" keywordseo="politics">politics</keyword>, something that's not likely to happen without massive systemic overhaul. Until then, we should start to look at the science industry more skeptically - not as an unbiased vehicle for truth, but as an industry as susceptible to malfeasance as any other. When oil companies produce "science" that shows global warming isn't real, we've all learned, rightly, to scoff. Perhaps we need to bring the same reading comprehension to drug science, and ask what ulterior motives lie behind our doctors' prescription pads.

The FDA is broken. It's controversial approval of an ineffective new Alzheimer's drug proves the agency puts profit over public health.

<div class="KonaFilter image-container display-table"><div><div class="image"></div></div></div><ul class="summary-list"><li>The US government is the single biggest buyer of healthcare, from Medicare for the elderly to Medicaid for some people with disabilities and those with low incomes.</li><li>We spoke to Seema Verma, the head of the Centers for Medicare and Medicaid Services, on the sidelines of the 2019 HLTH conference in Las Vegas about how she views the role of government in the industry. </li><li>Verma wants to see more competitive markets for private insurers. She also had a big warning for the healthcare industry about 'Medicare for All.'</li><li><a href="https://www.businessinsider.com/prime?r=US&amp;IR=TIR=T">Visit BI Prime for more stories.</a></li></ul>From where Seema Verma, the head of the Centers for Medicare and Medicaid Services, sits, the agency she oversees has a couple big roles to play in healthcare. The first is to be the safety net, there to care for the country's low-income and aging Americans. That has to be carried out sustainably, she said. At the same time, Verma said her role is to foster a competitive market for private insurers. Already, competition is fierce in Medicare Advantage, the program within the federal Medicare program in which coverage is provided by private insurers.Venture-backed startups <a href="https://www.businessinsider.com/health-insurance-startups-oscar-clover-devoted-bright-q2-financials-2019-8">Oscar Health, Devoted Health, Bright Health, and Clover Health</a> have raised a combined $3 billion to use technology to build new kinds of health-insurance plans and go after Medicare Advantage members. Insurers like <a href="https://www.businessinsider.com/unitedhealthmedicare-advantage-strategy-doctor-network-benefits-2019-10">UnitedHealth</a>, Aetna and Humana are battling for the 22 million Americans enrolled in Medicare Advantage plans, and the thousands signing up daily as they turn 65.The program is expected to grow from accounting for 34% <a href="https://www.kff.org/medicare/issue-brief/a-dozen-facts-about-medicare-advantage-in-2019/targetText=Between%202018%20and%202019,%20total,about%2047%20percent%20by%202029.">of the Medicare program to 47% by 2029.</a>Startups like Bright and Oscar have also made a big business on the individual exchanges created as part of the Affordable Care Act, often known as Obamacare. In an interview, Verma praised the success of the Medicare Advantage market, citing the addition of supplemental benefits and the ability to do virtual visits. She criticized Medicaid for its high spending, and the individual market for a lack of flexibility.On average, the government spends about $11,500 on each Medicare Advantage beneficiary, <a href="https://www.kff.org/report-section/financial-performance-of-medicare-advantage-individual-and-group-health-insurance-markets-issue-brief/">according to the Kaiser Family Foundation</a>. Per-person costs for Medicaid coverage varies widely, but are generally somewhat lower.As the head of CMS, Verma is responsible for Medicare, Medicaid, and the individual insurance markets, though states play a role as well. In a speech at the HLTH conference in Las Vegas, Verma noted that her agency oversees roughly $1 trillion in annual spending.Verma said there's a need for more government flexibility in Medicaid and in the individual market."I think a lot of times we're so top-down that it doesn't encourage innovation in that space," Verma told Business Insider on the sidelines of the HLTH conference. <h2>Getting a more competitive Medicaid market</h2>The Medicaid program provides coverage for some disabled and low-income individuals, as well as many mothers. Each state runs its own Medicaid program, and the costs are shared between the state and federal governments.Verma criticized the rising cost of Medicaid, and said action is need to control it. She said in a speech Sunday that the cost of providing long-term care in Medicaid is expected to grow from $68 billion in 2014 to $401 billion in 2050. "I think Medicaid hasn't quite delivered," Verma said.Medicaid is one of the top budget items for states, and nationally it's the third largest domestic program in the budget after social security and Medicare, accounting for 9.5% of federal spending as of 2017, <a href="https://www.kff.org/medicaid/issue-brief/10-things-to-know-about-medicaid-setting-the-facts-straight/">according to the Kaiser Family Foundation</a>. To be sure, Medicaid has a lot of support from the public. To date, <a href="https://www.kff.org/health-reform/state-indicator/state-activity-around-expanding-medicaid-under-the-affordable-care-act/?currentTimeframe=0&amp;sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D2%7D">37 states</a> and Washington, DC have decided to expand their Medicaid programs <a href="https://www.businessinsider.com/midterms-guide-to-healthcare-issues-on-ballot-medicaid-abortion-2018-11#three-red-states-voted-to-expand-medicaid-1">under the Affordable Care Act</a>. A <a href="https://www.nber.org/papers/w26081">recent study</a> showed that Medicaid expansion resulted in fewer deaths.But while the Medicare Advantage program has ways of measuring how well plans are keeping people healthy, Medicaid doesn't have the same metrics in place, she said. Verma said her agency plans to put out new scoring metrics, make sure Medicaid programs are functioning as they should, and give states more flexibility with their programs.<h2>The future of the ACA</h2>When it comes to making the individual exchanges as successful as the Medicare Advantage market, Verma pointed to the Affordable Care Act as a barrier to getting that done. "The law's so restrictive that it's not going to allow that," Verma said. "I think unless there's changes made to the law, our ability to really, ensure more affordability's thwarted." Verma pointed to those forgoing insurance because of cost. In 2018, <a href="https://www.vox.com/policy-and-politics/2019/9/10/20858938/health-insurance-census-bureau-data-trump">the uninsured rate rose to 8.5% of Americans, up from 7.9% the year prior</a>. To provide cheaper coverage, the administration has loosened the rules for short-term health plans, <a href="https://www.businessinsider.com/trump-obamacare-short-term-health-insurance-plans-2018-8">controversial health insurance coverage</a> that's meant to be used for a few months at a time. The plans don't necessarily have the same level of coverage as plans offered on the individual exchanges, however. Verma was appointed by President Donald Trump, a Republican who campaigned heavily on the promise of repealing the ACA. The health law was signed in 2010 by then-President Barack Obama, a Democrat.The future of the ACA and the individual exchanges it created are up in the air. A federal court in New Orleans is expected to rule on the legality of the law, and the administration hasn't said what contingency plans it has ready if the ACA were to be struck down."We've prepared for a number of different scenarios," Verma said, echoing comments<a href="https://www.businessinsider.com/trump-medicare-chief-seema-verma-avoided-questions-obamacare-backup-plan-2019-10"> she made in a congressional hearing on Thursday.</a> Verma declined to elaborate on the specifics of those scenarios."I think the president's been very clear that we want to make sure that Americans have access to affordable coverage, and so there'll be a plan in place, she said"To her, the end of the ACA could provide a chance to fix some of the issues that still affect the individual exchanges, such as affordability for those who don't qualify for subsidized premiums. Premium subsidies are based on individual and family's incomes, with those who earn less <a href="https://www.kff.org/health-reform/issue-brief/explaining-health-care-reform-questions-about-health/">receiving more subsidies.</a>"I think it could be an opportunity, quite frankly, to address some of the problems in Obamacare," she said.<h2>Verma's warning to the healthcare industry</h2>Nationally, support has been growing for "Medicare for All" or the idea of single-payer healthcare in the US. It's been a key issue in the Democratic presidential primary race. Verma for her part has been <a href="https://time.com/5703280/seema-verma-bernard-tyson-time-100-health/">critical</a>.Verma said the healthcare industry needs to make changes, so that consumers don't feel like they need the government to be in charge of their healthcare. "We are where we are because people are very frustrated, and to not listen to that I think is derelict on the healthcare industry's part," Verma said. "The status quo is not working for the American people and they're demanding change," she said. "And if we don't, provide those solutions, people are calling for the government. I don't think the government can solve the problem. I think they will make it worse."<a href="/intelligence/digital-health?IR=T&amp;itm_source=businessinsider&amp;itm_medium=ctgr_bii&amp;itm_term=ctgr_subscription&amp;itm_content=health&amp;itm_campaign=digital-health-3"></a>Featured Digital Health Articles: - <a href="/telehealth-industry-explained">Telehealth Industry: Benefits, Services &amp; Examples</a> - <a href="/value-based-care-pay-for-performance-healthcare-model">Value-Based Care Model: Pay-for-Performance Healthcare</a> - <a href="/senior-care-market-trends">Senior Care &amp; Assisted Living Market Trends</a> - <a href="/wearable-technology-healthcare-medical-devices">Smart Medical Devices: Wearable Tech in Healthcare</a> - <a href="/artificial-intelligence-healthcare">AI in Healthcare</a> - <a href="/remote-patient-monitoring-industry-explained">Remote Patient Monitoring Industry: Devices &amp; Market Trends</a>

Trump's Medicare chief oversees a budget of $1 trillion. We spoke with her about what she wants to see from the private healthcare industry

Welcome to <keyword id="9884466" type="UNKNOWN" weightage="60" keywordseo="insider-cannabis">Insider Cannabis</keyword>, our weekly newsletter where we're bringing you an inside look at the deals, trends, and personalities driving the multibillion-dollar global <keyword id="14728" type="ENTERTAINMENT" weightage="60" keywordseo="cannabis">cannabis</keyword> boom.<a href="http://newsletter.businessinsider.com/join/cultivated">Sign up here to get it in your inbox every week</a>.Happy Friday readers,I hate to be cliche, but we are living in monumental times — with <a href="https://www.businessinsider.com/trump-coronavirus-diagnosis-election-impact-running-out-of-time-2020-10">President Trump's COVID-19 diagnosis</a>, it's impossible to know what will happen next.Despite the crush of the news cycle leading up to November, life still goes on, and Yeji and I still have a ton of cannabis news for you all.Let's get to it.-JeremyHere's what we wrote about this week:<h3><a href="https://www.businessinsider.com/cannabis-law-firms-psychedelics-industry-clients-2020-9">Lawyers who specialize in cannabis are eyeing the burgeoning psychedelics industry as companies studying magic mushrooms go public</a></h3>Lawyers who specialize in the cannabis industry say they're getting inquiries from a new kind of client: psychedelics companies.The calls started coming in around a year to a year and a half ago, as the psychedelics industry began to ramp up and garner more investor dollars, half a dozen cannabis lawyers told Business Insider. Some firms say they're diving headfirst into the psychedelics industry. Others say they're watching the industry closely from the sidelines, waiting for more regulatory changes before they take on the new client base.<h3><a href="https://www.businessinsider.com/flowhub-hires-former-glassdoor-exec-stephanie-jenkins-svp-of-sales-2020-10">Flowhub just scooped up a senior exec from Glassdoor, and it's the latest sign that the cannabis tech space is heating up</a></h3>Stephanie Jenkins, formerly an exec at the job-hunting site Glassdoor, made the jump into the cannabis industry recently as Flowhub's senior vice president of sales. Flowhub is a cannabis tech company that helps dispensaries track inventory and process sales. The startup — backed by $27 million in funding so far — was named to Business Insider's list of the <a href="https://www.businessinsider.com/cannabis-startups-popular-hot-in-2020-according-to-vcs-2020-1#headset-2-votes-11">15 buzziest startups in cannabis</a>. The move sends a strong signal that investors and executives from inside and outside of cannabis think that the tech side of the industry has a lot of growth potential. <h2>Executive moves</h2><ul><li>Agrify Corporation names former Ocean Spray Cranberries exec Richard Stamm <a href="https://www.prnewswire.com/news-releases/agrify-corporation-appoints-richard-stamm-as-new-general-counsel-301139509.html?tc=eml_cleartime">as new General Counsel and Corporate Secretary</a>.</li><li>Flowhub brings on former Glassdoor executive <a href="https://www.businessinsider.com/flowhub-hires-former-glassdoor-exec-stephanie-jenkins-svp-of-sales-2020-10">Stephanie Jenkins as SVP of sales</a>. </li><li>Ontario Cannabis Store appointed Thomas Haig as <a href="https://www.bnnbloomberg.ca/ontario-appoints-former-hbc-giant-tiger-exec-to-run-its-pot-business-1.1500538">its new interim president on Monday</a>. Haig previously served as an exec at Hudson's Bay Company and Giant Tiger Stores, a discount chain. </li><li>Billionaire investor <a href="https://www.newswire.ca/news-releases/aurora-cannabis-announces-date-of-annual-general-meeting-805914950.html">Nelson Peltz is out at Aurora</a>, resigning as a senior advisor to the company. </li><li>Troubled cannabis company <a href="https://www.globenewswire.com/news-release/2020/09/30/2101514/0/en/Green-Growth-Brands-Announces-Resignation-of-Interim-CEO.html">Green Growth Brands announced the departure of its CEO</a>, Randy Whitaker, who took the top job in May. There will be no immediate replacement. </li><li>Cannabis accessories company Greenlane Holdings <a href="https://www.globenewswire.com/news-release/2020/09/21/2096502/0/en/Greenlane-Holdings-Appoints-Key-Sales-and-Marketing-Hires-for-North-America-and-Europe.html">hired a pair of former tobacco execs</a>, Michael Cellucci and Michael Ouwendijk, to head up sales in North America and Europe respectively. </li></ul><h2>Deals, launches, and IPOs</h2><ul><li>Canopy Growth is <a href="https://www.prnewswire.com/news-releases/canopy-growth-and-acreage-holdings-announce-initial-plans-to-launch-thc-infused-beverages-in-the-us-next-summer-301143758.html">launching THC-infused beverages</a> in Illinois and California through its partnership with Acreage Holdings next summer.</li><li>Ayr Strategies <a href="https://ir.ayrstrategies.com/news-events/press-releases/detail/45/ayr-strategies-enters-into-agreements-to-expand-operations">enters the Ohio market</a>, expanding the cannabis company's presence to the Midwest.</li><li>Cannabis company ManifestSeven <a href="https://www.manifest7.com/2020/09/28/manifestseven-listing/">began trading on the Canadian Securities Exchange</a> on Wednesday. </li><li>Cannabis company J<a href="https://www.globenewswire.com/news-release/2020/10/01/2102111/0/en/Jushi-Holdings-Inc-Expects-Record-Third-Quarter-Revenue-of-Approximately-24-Million.html">ushi Holdings reported Q3 revenue</a> of $24 million.</li></ul><h2>Policy Moves</h2><ul><li>House Democrats passed a sweeping stimulus bill that included the SAFE Banking Act, a piece of legislation that would allow state-legal cannabis businesses to access banking services much like any other business. It's not likely to pass the Senate, however. My colleague Kimberly Leonard <a href="https://www.businessinsider.com/stimulus-checks-coronavirus-details-house-democrats-pelosi-mnuchin-2020-9?utmSource=twitter&amp;utmContent=referral&amp;utmTerm=topbar&amp;referrer=twitterrrer=twitter">has what you need to know</a>. </li></ul><div type="image" title="Cannabis" height="1334" width="2000" msid="78451057" hostid="261"></div><h2>Research and reform</h2><ul><li>A University of Montana study found that legalizing and taxing cannabis in the state <a href="http://bber.umt.edu/pubs/Econ/CannabisStudy2020.pdf">could generate $236 million</a> in tax revenue by 2026. </li><li>Pot-for-potholes is not a panacea, <a href="https://taxfoundation.org/arizona-montana-south-dakota-new-jersey-recreational-marijuana/">says the Tax Foundation in a new blog post</a>. Excise taxes from legalizing cannabis will not likely fill budget gaps, though the taxes from new businesses and job creation will still be a boon for states that do choose to legalize. </li><li>According to new data from the FBI, <a href="https://ucr.fbi.gov/crime-in-the-u.s/2019/crime-in-the-u.s.-2019/topic-pages/persons-arrested?link_id=2&amp;can_id=368bbf085178dd7d3b7f9ea734c170f9&amp;source=email-fbi-marijuana-arrests-outpace-arrests-for-all-violent-crimes&amp;email_referrer=email_943424&amp;email_subject=fbi-marijuana-arrests-outpace-arrests-for-all-violent-crimesl-violent-crimes">marijuana arrests in the US declined for the first time in four years</a>. The bad news is that <keyword id="40905" type="PERSON" weightage="60" keywordseo="Marijuana">marijuana</keyword> arrests still outpaced arrests for all other violent crimes combined. </li><li>43% of 19-to-22-year-olds in the US used marijuana in the past year, <a href="https://www.drugabuse.gov/news-events/news-releases/2020/09/vaping-marijuana-use-in-2019-rose-in-college-age-adults?utm_source=twitter&amp;utm_medium=social&amp;utm_campaign=mtf_2020092820200928">according to a NIDA study</a>. Prescription opioid and amphetamine abuse among the same age bracket continues to decline. </li></ul><h2>Chart of the week</h2>Wholesale cannabis sales skyrocketed in states like California, Arizona, and Colorado this August, compared to the same month last year, according to data from <a href="https://www.resources.leaflink.com/insights-flash-september">LeafLink Insights</a>. The cannabis software company told Business Insider that year-over-year, between Aug 2019 to Aug 2020, gross merchandise value (GMV), the total value of merchandise sold, increased 132%.Michigan, with a 112% increase, saw the biggest uptick, though that's in large part to recreational sales coming online last December. Nevada — with a market heavily dependent on cannabis tourism — was the only state of the six surveyed to see a decline in sales year-over-year.<div type="image" title="yrshx yoy wholesale cannabis sales aug 2019 vs aug 2020" height="1050" width="1340" msid="78451058" hostid="261"></div><h2>What we're reading </h2><a href="https://cannabiswire.com/2020/09/29/a-political-mystery-the-cannabis-money-pushing-to-keep-the-us-senate-red/">A political mystery: The cannabis money pushing to keep the US senate red</a> (Cannabis Wire)<a href="https://techcrunch.com/2020/09/28/cannabis-vape-companies-experiencing-sales-boom-during-pandemic/">Cannabis vape companies are experiencing a sales boom during the pandemic</a> (Tech Crunch) <a href="https://www.theguardian.com/world/2020/oct/01/gone-to-pot-new-zealand-cools-on-legalising-cannabis">Gone to pot: New Zealand cools on legalising cannabis</a> (The Guardian)<a href="https://www.reuters.com/article/us-mexico-cannabis-insight/mexico-plagued-by-cartel-wars-on-cusp-of-legal-cannabis-green-rush-idUSKBN26M5UI">Mexico, plagued by cartel wars, on cusp of legal cannabis 'green rush'</a> (Reuters)<a href="https://mjbizdaily.com/aurora-cannabis-execs-saw-raises-bonuses-despite-multibillion-dollar-loss/">Aurora Cannabis execs saw raises, bonuses despite multibillion-dollar loss</a> (Marijuana Business Daily)

Insider Cannabis: Law firms eyeing psychedelics — Flowhub scoops a senior Glassdoor exec — Cannabis in the COVID relief bill

<ul class="summary-list"><li>On May 15, President Donald Trump launched <a href="https://www.businessinsider.com/category/operation-warp-speed">Operation Warp Speed</a> to find a <keyword id="8624004" type="UNKNOWN" weightage="60" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> by January 2021 and secure enough for every American.</li><li>But, right now, <a href="https://www.businessinsider.com/coronavirus-vaccine-glass-vial-shortage-could-delay-global-rollout-2020-5">there is a global shortage of the glass vials used to bottle vaccines</a>, which could prevent a global inoculation drive.</li><li>Earlier this month <keyword id="9233448" type="UNKNOWN" weightage="60" keywordseo="operation-warp-speed">Operation Warp Speed</keyword> approved partnerships worth $347 million with two American vial makers, SiO2 and <keyword id="435920" type="CITY" weightage="60" keywordseo="Corning">Corning</keyword>, in an attempt to remedy the shortage.</li><li>Both companies spoke to Business Insider about their daunting tasks ahead. SiO2 is working to ramp up capacity almost eightfold, while Corning is trying to increase production fourfold.</li><li>The production of glass vials has historically been slow and labor-intensive. Experts have warned of Operation Warp Speed's focus on speed and fear of "steps being skipped."</li></ul>The US government is pouring $347 million into two American vial makers so they can ramp up production and avoid global shortages ahead of a <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword> rollout.Last month, <a href="https://www.businessinsider.com/coronavirus-vaccine-glass-vial-shortage-could-delay-global-rollout-2020-5">experts told Business Insider of a dearth</a> in the glass vials used to bottle vaccines, which could delay a global vaccine rollout even when one is approved. <a href="https://www.businessinsider.com/bill-gates-buying-glass-vials-for-billions-of-coronavirus-vaccines-2020-5">Bill Gates</a> and AstraZeneca CEO <a href="https://www.biopharmadive.com/news/coronavirus-vaccine-vials-supply-bottleneck/578793/">Pascal Soriot</a> are among those <a href="https://www.businessinsider.com/coronavirus-vaccine-glass-vial-shortage-could-delay-global-rollout-2020-5">sounding the alarm.</a><a href="https://www.businessinsider.com/coronavirus-vaccine-glass-vial-shortage-could-delay-global-rollout-2020-5">Dr. Rick Bright</a>, the former head of the US Biomedical Advanced Research and Development Authority (<keyword id="2832405" type="PERSON" weightage="60" keywordseo="Barda">BARDA</keyword>), also said in a <a href="https://www.kmblegal.com/sites/default/files/NEW%20R.%20Bright%20OSC%20Complaint_Redacted.pdf">whistleblower complaint</a> that he warned the Department of Health and Human Services (HHS) of a "critical shortage" of glass vials.<h2>Operation Warp Speed</h2>As the dust from the complaint settled, the White House launched <a href="https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-leadership-for-operation-warp-speed.html">Operation Warp Speed</a> (OWS) on May 15.It's a <a href="https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html">public-private partnership</a> run by several government departments, including HHS, BARDA, the Defense Department, Centers for Disease Control and Prevention, Food and Drug Administration, and the National Institutes of Health.Its aim is to find, make, and distribute a vaccine in the US by January 2021.OWS has a budget of $10 billion from the federal government, which officials have since invested in the private sector.Finding an actual vaccine has drawn most of the funding, but one key problem remains: how to overcome the vial shortage?<div type="image" title="corning valor glass vaccine" height="2290" width="4580" msid="76511032" hostid="261"></div>In an attempt to solve it, BARDA and the Pentagon signed contracts — approved by OWS — worth $347 million in early June with Corning and SiO2, two US-based vial makers, so they could ramp up production.The contracts represent just under 3.5% of Operation Warp Speed's $10 billion budget."The federal government expects domestic surge capacity for vials over the next three years," a HHS spokesperson told Business Insider, adding that both companies "have a performance period of three years with potential options extending out the agreement to ten years."The HHS said targets and specific deadlines under the contracts are confidential.However, Business Insider spoke with both companies, which laid out the scale of the task ahead of them.<div type="image" title="Moncef Slaoui vaccine coroanvirus Trump White House May 15 Rose Garden Operation Warp Speed" height="800" width="1600" msid="76511034" hostid="261"></div><h2>SiO2 'scaling like hell'</h2>SiO2, which signed a <a href="https://www.sio2ms.com/news/48-barda">$143 million</a> partnership with BARDA, has been asked to ramp up production of its 10 ml vials more than eightfold."BARDA said: 'Hey, we have an issue with glass shortage,'" Lawrence Ganti, chief business owner of SiO2, told Business Insider. "And we explained, if we have money and resources we can ramp up in three to four months."Before the coronavirus outbreak, SiO2 had capacity to make 14 million of its 10 ml vials a year.The BARDA contract has mandated it to scale up capacity to make 40 million in June, 80 million in September, and 120 million in November."We are scaling like hell," Ganti said.It's not clear whether it has hit its 40 million target yet.<div type="image" title="A view of the 165,000 square-foot SiO2 manufacturing plant in Auburn, Alabama." height="1350" width="2721" msid="76511035" hostid="261"></div>BARDA is keeping a close watch on SiO2's work and is tracking its progress on a Microsoft Excel document with 590 rows of targets, Ganti said.SiO2 is also hiring 200 staff — doubling its workforce — to meet the increased demand for work."Every dollar is accounted for. It's been earmarked, it's not like we can say: 'Woohoo, let's have a party.' As you can imagine, the government wants to see where it's going," he said."We have very strict milestones," Ganti said. <h2>Corning tasked to increase capacity tenfold</h2>Corning, whose Pyrex glass was used to bottle polio vaccines in the 1950s, <a href="https://www.corning.com/worldwide/en/about-us/news-events/news-releases/2020/06/us-departments-of-defense-health-human-services-select-corning-valor-glass-packaging-to-accelerate-delivery-of-covid-19-vaccines.html">signed</a> a $204 million deal to create more of its "Valor" glass vials for the government."Valor" glass is more durable than other glasses used to bottle vaccines, according to Corning, meaning it can help minimize delivery delays caused by breakages.BARDA has tasked Corning to increase capacity for this glass by ten times over the next three years.<div type="image" title="Pfizer BioNTech coronavirus vaccine clinical trial, vaccination of first volunteer" height="3008" width="6016" msid="76511039" hostid="261"></div>Before the coronavirus outbreak, Corning had the capacity to manufacture "millions of vials per month," but is now "ramping aggressively" in light of the BARDA deal, spokeswoman Gabrielle Bailey told Business Insider."By the end of 2020, we're targeting an annual capacity increase of three to four times our existing," Bailey said.Ronald Verkleeren, senior VP and general manager of Corning's life sciences division, declined to give exact figures for Corning's current or planned stock, but told Business Insider BARDA wants "sufficient capacity to handle certainly the needs of the US market."Verkleeren also confirmed that, during the early stages of the pandemic, concerns over a shortage were warranted."Glass production is a fairly capital-intensive process by its nature, so manufacturers of glass weren't sitting around with a lot of empty vial capacity," he said."We are seeing more orders and more interest in our product, and I would say that is probably related to the overall economics of the supply chain."<div type="image" title="SiO2_Inspection_Vial_3 (1)" height="600" width="1200" msid="76511046" hostid="261"></div><h2>An 'insurmountable' task</h2>SiO2 and Corning are faced with ambitious goals, and whether or not they can fulfil them in record time remains to be seen.The production of glass vials has historically been slow and labor-intensive."They take months to manufacture and the world has only created a capacity for what it uses for everyday treatments, so there is no surge capacity," Marc Koska, the inventor of a <a href="https://www.newscientist.com/article/mg21228386-500-my-self-destructing-syringe-could-save-millions-of-lives/">self-destructing syringe</a> that helped reduce HIV transmission, <a href="https://us.bremont.com/blogs/blogbook/marc-koska-we-can-make-a-breakthrough">said</a> in March.Experts have previously doubted the ability to ramp up vial production in time for a coronavirus vaccine rollout, with one calling the manufacturing work "<a href="https://www.nytimes.com/interactive/2020/04/30/opinion/coronavirus-covid-vaccine.html?referringSource=articleShare">insurmountable</a>."Prashant Yadav, a <keyword id="6354525" type="UNKNOWN" weightage="60" keywordseo="healthcare">healthcare</keyword> supply chain expert at the Center for Global Development, <a href="https://www.businessinsider.com/coronavirus-vaccine-glass-vial-shortage-could-delay-global-rollout-2020-5">told Business Insider last month</a> that to scale up production, vial maker employees would effectively have to work "the same way as the scientists, 20 hours a day, to make more vials and increase capacity."<div type="image" title="A scientist checks quality control of vaccine vials for correct volume at the Clinical Biomanufacturing Facility (CBF) in Oxford, Britain, April 2, 2020. Picture taken April 2, 2020. Sean Elias/Handout via REUTERS THIS IMAGE HAS BEEN SUPPLIED BY A THIRD PARTY. MANDATORY CREDIT. NO RESALES. NO ARCHIVES" height="1888" width="3777" msid="76511050" hostid="261"></div><h2>BARDA left out companies already equipped to meet demand</h2>Corning and SiO2 are by no means the world's largest vial makers, but — as is vital for the US government — are based in America.Other major vial makers, like the German firm Schott AG, were not approached by BARDA.Dr. Frank Heinricht, Schott's chairman, told Business Insider the US government had taken the vials industry by surprise when it tasked two relatively left-field firms to scale up production, when other firms like Schott, Germany's Gerresheimer, and Italy's Stevanato Group were already equipped to meet demand."We have been very much surprised by this reaction from the government," he said.He added that the timelines given to Corning and SiO2 seem unrealistically short, given the scale of the task ahead. "It will take, from today's perspective, maybe 18 months before the capacity is up," he said, referring to vial production levels.<div type="image" title="A vial made with borosilicate glass, the material which will be used in vials or syringes to hold the eventual coronavirus disease (COVID-19) vaccine, is pictured with a syringe at an undisclosed location in this undated handout image courtesy of Schott AG. To match Exclusive HEALTH-CORONAVIRUS/SCHOTT SCHOTT AG/Handout via REUTERS ATTENTION EDITORS - THIS IMAGE HAS BEEN SUPPLIED BY A THIRD PARTY. MANDATORY CREDIT. NO RESALES. NO ARCHIVES." height="1240" width="2480" msid="76511056" hostid="261"></div>Schott is currently working on several active orders from its clients, each asking for between ten to 30 million vials, he said. He declined to name Schott's clients or say how many orders the company is fielding.Schott is also boosting capacity by 35% in light of the need for a coronavirus vaccine, Heinricht said.When asked about the US government signing contracts with just two vial makers, a HHS spokesperson told Business Insider it would "welcome additional proposals" from other companies.Other glass vial makers have also seen increased demand in recent months. The California-based Argonaut Manufacturing Services told Business Insider it had seen a "tightening of the supply chain in general and for glass."<div type="image" title="Vials made with borosilicate glass, the material which will be used in vials or syringes to hold the eventual coronavirus disease (COVID-19) vaccine, are seen during the production process at an undisclosed location in this 2013 handout image courtesy of Schott AG. To match Exclusive HEALTH-CORONAVIRUS/SCHOTT Alexander Sell/SCHOTT AG/Handout via REUTERS ATTENTION EDITORS - THIS IMAGE HAS BEEN SUPPLIED BY A THIRD PARTY. MANDATORY CREDIT. NO RESALES. NO ARCHIVES." height="2106" width="4211" msid="76511060" hostid="261"></div><h2>'Steps being skipped'</h2>As the name suggests, Operation Warp Speed is focused on accelerating timelines. The name was derived from <a href="https://www.youtube.com/watch?v=kZGFuH_aPgM">a fictional method of space travel popularized in "Star Trek."</a>However, very little is known about how OWS operates.When asked about OWS's work at a Senate Armed Service Committee <a href="https://www.armed-services.senate.gov/imo/media/doc/Perna%20APQs_%2006-18-20.pdf">hearing last week</a>, Gen. Gustave Perna remained vague, saying at one point: "Both industry and our government's supporting agencies, resourcing and execution processes must also move at Warp Speed for success; I will have to ensure that our collective bureaucracies do not distract us from Winning!"But critics say this message could be detrimental because it implies safety is being overlooked. The <a href="https://www.businessinsider.com/anti-vaxxers-oppose-a-coronavirus-vaccine-that-doesnt-exist-2020-5"> anti-vaxxer movement is already seizing on</a> this message to claim a coronavirus vaccine may be dangerous."It makes people think there are steps being skipped," Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics at Children's Hospital of Philadelphia, <a href="https://edition.cnn.com/2020/06/05/health/warp-speed-coronavirus-vaccine-worries/index.html">told CNN</a>."The way they are messaging it is a little frightening because they make a point of saying how quickly it is being done."Dr. Peter Hotez, dean of the National School of Tropical Medicine, also told CNN: "The way the message is coming out of Operation Warp Speed creates a lot of chaos and confusion. And it is enabling the anti-vaccine movement."<div type="image" title="wuhan hospital coronavirus icu patients" height="1100" width="2200" msid="76511062" hostid="261"></div>It is not yet known which vaccine will fill the SiO2 and Corning's vials.It will likely be <a href="https://www.nytimes.com/reuters/2020/06/04/world/europe/04reuters-health-coronavirus-usa-vaccine.html">one of the five potential vaccines</a> supported by BARDA, which are associated with AstraZeneca, Johnson &amp; Johnson, Merck, Moderna, and Pfizer.SiO2's Ganti told Business Insider it is working with <a href="https://www.businessinsider.com/moderna-origins-ceo-cofounder-interviews-and-inside-the-lab-2020-5">Moderna</a> and three other drugmakers that are developing coronavirus vaccine candidates, but declined to name the three other companies.Dr. Anthony Fauci, the top US epidemiologist, <a href="https://www.youtube.com/watch?v=3MH-3ICY-N4">said on June 2</a> that he believes a vaccine will be ready to for mass production by December.Read more: <a href="https://www.businessinsider.com/operation-warp-speed-details-coronavirus-vaccine-timeline-pricing-2020-6">The US will make a coronavirus vaccine free to 'vulnerable' Americans, a senior Operation Warp Speed official pledges</a><div type="image" title="Coronavirus New York City" height="2700" width="5400" msid="76511069" hostid="261"></div><h2>'For the greater good'</h2>Both Corning and SiO2 said the traditionally competitive mindset in the industry has gone out the window during the coronavirus pandemic, given its leveling effects.Verkleeren, from Corning, told Business Insider: "I think everybody is looking at it, by and large, for the greater good. We have a global crisis so let's do something to help. It's not like there's some kind of vicious rivalry."SiO2's Ganti also told Business Insider of his employees: "There's a buzz, there's a lot of excitement. On one hand, it's more hours, it's more work, but they feel good that they're working for the common good."

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