The U.S., China, and Russia are in a "vaccine race" that treats a global challenge like a winner-take-all game.
All for one (vaccine)<p>Launched this April, <a href="https://www.who.int/initiatives/act-accelerator" target="_blank">the Access to COVID-19 Tools (ACT) Accelerator</a> brought together a panoply of governments, scientists, businesses, and global health organizations with the goal of accelerating the development, production, and distribution of an efficacious COVID-19 vaccine. The "vaccines pillar" of this initiative is <a href="https://www.gavi.org/vaccineswork/covax-explained" target="_blank">the COVAX Facility</a>.</p><p>COVAX is coordinated by the WHO, the Coalition for Epidemic Preparedness Innovations (CEPI), and Gavi, the Vaccine Alliance. The program maintains a diverse portfolio of COVID-10 vaccines, monitoring each to identify promising candidates. It has also partnered with manufacturers to ease investment risks and serves as a purchasing pool for self-financing countries, while offering fundraising efforts to poorer ones.</p><p>"[G]overnments from every continent have chosen to work together, not only to secure vaccines for their own populations, but also to help ensure that vaccines are available to the most vulnerable everywhere," Seth Berkley, CEO of Gavi, <a href="https://www.gavi.org/news/media-room/boost-global-response-covid-19-economies-worldwide-formally-sign-covax-facility" target="_blank">said in a release</a>. "With the commitments we're announcing today for the COVAX Facility, as well as the historic partnership we are forging with industry, we now stand a far better chance of ending the acute phase of this pandemic once safe, effective vaccines become available."</p><p><a href="https://www.vox.com/21448719/covid-19-vaccine-covax-who-gavi-cepi" target="_blank" rel="noopener noreferrer">In an interview with Vox</a>, Berkley noted that the ACT Accelerator is the largest global collaboration since the Paris Climate Agreement. He added, "This type of solidarity is critical because otherwise what you're going to end up with is just a constant reintroduction of infections and the inability to go back to normal."</p><p>As of Monday, 64 higher-income countries and 92 low- and middle-income countries—representing nearly two-thirds of the world's population—<a href="https://www.gavi.org/news/media-room/boost-global-response-covid-19-economies-worldwide-formally-sign-covax-facility" target="_blank" rel="noopener noreferrer">have signed commitments to COVAX</a>. Thirty-eight more are expected to sign soon.</p><p>COVAX's goal is to have 2 billion doses by the end of 2021. Experts estimate this amount will cover high-risk and vulnerable people, as well as healthcare workers, worldwide. Participating nations must cover those populations before administering vaccines according to national priorities. As part of the agreement, countries agree to support equal access to the vaccine once it becomes available, a move aimed at preventing hoarding and price gouging. </p><p>Currently, CEPI is supporting nine candidate vaccines, of which eight are in clinical trials.</p>
Why has the U.S. backed out?<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="7167e0bf1593a7cb29c1a116041116e3"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/LUAsKbH7yeY?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>The United States is gambling that its bilateral deals with various pharmaceutical companies will win the "<a href="https://www.washingtonpost.com/world/coronavirus-vaccine-trump/2020/09/01/b44b42be-e965-11ea-bf44-0d31c85838a5_story.html" target="_blank" rel="noopener noreferrer">vaccine race</a>." This U.S.-only initiative, named (sigh) <a href="https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html" target="_blank" rel="noopener noreferrer">Operation Warp Speed</a>, has already spent <a href="https://www.cnbc.com/2020/08/14/the-us-has-already-invested-billions-on-potential-coronavirus-vaccines-heres-where-the-deals-stand.html" target="_blank" rel="noopener noreferrer">approximately $10 billion</a> and is pushing to deliver 300 million doses by January 2021. Many experts worry this speedy push through the regulatory path could result in <a href="https://www.sciencemag.org/news/2020/08/here-s-how-us-could-release-covid-19-vaccine-election-and-why-scares-some" target="_blank" rel="noopener noreferrer">premature and dangerous approvals</a>.</p><p>China and Russia have likewise bet on their own high-priced ponies. Russia is touting <a href="https://arstechnica.com/science/2020/09/russia-offers-its-untested-covid-19-vaccine-for-free-to-un-officials/" target="_blank" rel="noopener noreferrer">an unvetted vaccine</a> nicknamed (double sigh) "Sputnik V." This vaccine has only concluded <a href="https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30402-1/fulltext" target="_blank" rel="noopener noreferrer">phase 1 and 2 trials</a> with a small number of participants, yet Russia claims to have already received international requests. Meanwhile, China has administered <a href="https://www.reuters.com/article/us-health-coronavirus-china-vaccines-foc/in-coronavirus-vaccine-race-china-inoculates-thousands-before-trials-are-completed-idUSKBN26705Q" target="_blank" rel="noopener noreferrer">tens of thousands of doses of a vaccine</a> before completing phase 3 clinical trials. </p><p>An additional barrier to the United States' participation: COVAX is a WHO-led initiative. Earlier this year, <a href="https://www.npr.org/2020/05/29/865685798/president-trump-announces-that-u-s-will-leave-who" target="_blank" rel="noopener noreferrer">President Donald Trump admonished the WHO as a corrupt organization</a> and claimed it assisted China in covering up the coronavirus outbreak and its severity. Though he presented no evidence for the accusation, Trump has used it as the basis for <a href="https://www.statnews.com/2020/09/21/64-high-income-nations-join-effort-to-expand-global-access-to-covid-19-vaccines-but-u-s-and-china-do-not/" target="_blank" rel="noopener noreferrer">his threat to cut ties with</a>, and funding for, the agency.</p><p>"The United States will continue to engage our international partners to ensure we defeat this virus, but we will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China," said Judd Deere, a spokesman for the White House, said <a href="https://www.reuters.com/article/us-health-coronavirus-usa-who/white-house-slams-who-over-criticism-of-push-for-covid-19-vaccine-idUSKBN25S62T" target="_blank" rel="noopener noreferrer">in a statement</a>.</p><p>He added, "This president will spare no expense to ensure that any new vaccine maintains our own FDA's gold standard for safety and efficacy, is thoroughly tested, and saves lives."</p><p>By shirking COVAX, these countries hope to gain peerless access to a vaccine. Each could secure large numbers of doses for its citizens while also reaping the political boons to follow. In the United States, President Trump has pinned his re-election bid on a timely vaccine, while Chinese officials seem posed to use a vaccine <a href="https://www.nytimes.com/2020/09/11/business/china-vaccine-diplomacy.html" target="_blank" rel="noopener noreferrer">to repair diplomatic ties</a>. </p><p>But the loss of such rich economies will prove a blow to COVAX and the ACT Accelerator. Vaccines are notoriously expensive and risky to develop; the costs to manufacture doses at scale will be immense. <a href="https://news.un.org/en/story/2020/08/1070162" target="_blank" rel="noopener noreferrer">WHO Director-General Tedros Adhanom Ghebreyesus</a> stated the ACT Accelerator would cost roughly $30 billion, and the final bill for the tools to combat novel coronavirus would be at least $100 billion. But that's a pittance compared to the <a href="https://www.reuters.com/article/us-health-coronavirus-imf/imf-says-10-trillion-spent-to-combat-pandemic-far-more-needed-idUSKBN23I27P" target="_blank" rel="noopener noreferrer">$10 trillion already spent on the pandemic</a> so far.</p><p>"COVID-19 is an unprecedented global crisis that demands an unprecedented global response," <a href="https://www.who.int/news-room/detail/21-09-2020-boost-for-global-response-to-covid-19-as-economies-worldwide-formally-sign-up-to-covax-facility" target="_blank" rel="noopener noreferrer">Tedros said</a>. "Vaccine nationalism will only perpetuate the disease and prolong the global recovery. Working together through the COVAX Facility is not charity, it's in every country's own best interests to control the pandemic and accelerate the global economic recovery."</p>
The winner won't necessarily take all<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDQzNzY2My9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0NjExMzA1M30.2kF2U_8veNWxmaxOnSned_WTQMRtscbB5dmT5efJHsc/img.jpg?width=1245&coordinates=0%2C180%2C0%2C181&height=700" id="55cd7" class="rm-shortcode" data-rm-shortcode-id="c56717cda300a40edc23795c8ee23c2f" data-rm-shortcode-name="rebelmouse-image" alt="SARS-CoV-2 vaccine" />
Addiction is not a moral failure. It is a learning disorder, and viewing it otherwise stops communities and policy makers from the ultimate goal: harm reduction.
- "Why are some drugs legal and others illegal? ... if you ask how and why this distinction got made, what you realize when you look at the history is it has almost nothing to do with the relative risks of these drugs and almost everything to do with who used and who was perceived to use these drugs," says Ethan Nadelmann.
- In this video, Maia Szalavitz, public policy and addiction journalist; Carl Hart, professor of neuroscience and psychology at Columbia University; Ethan Nadelmann, founder of the Drug Policy Alliance; and Harvard University economist Jeffrey Miron dissect why American society's perceptions of drug addiction and its drug policies are so illogical.
- Drug addiction is not a moral failure and the stereotypes about who gets addicted are not true. Policy that is built to punish drug users for their immorality only increases harm and death rates.
That question is at the heart of the new documentary, "Medicating Normal."
- The directors of the new documentary, "Medicating Normal," want psychiatrists to require informed consent when writing prescriptions.
- Long-term effects of antidepressant usage do not have to be documented for FDA approval.
- Big Think talks to producer/director Wendy Ratcliffe and film subject, Angela Peacock.
EarthRise Podcast 93: Medicating Normal (with Angela Peacock & Wendy Ratcliffe)<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="a687fe66beb23c435464e7ad203757ca"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/CKUQkUd_ljw?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>During our talk, Peacock is seated next to director and producer, Wendy Ratcliffe. Co-director Lynn Cunningham was initially inspired to pursue this topic when a family member's health deteriorated after 15 years of psychiatric medication. A Harvard graduate and star athlete, this family member is now on disability and exhibits poor mental health. </p><p>This brings up a question modern psychiatry rarely confronts: Why are prescription drug rates and rates of anxiety and depression increasing? If the former worked, shouldn't the latter be in decline?</p><p>That's not what's happened. Ratcliffe decided to produce "Medicating Normal" after reading Robert Whitaker's 2010 book, "Anatomy of an Epidemic." (Whitaker is featured in the film and was recently <a href="https://bigthink.com/mind-brain/antidepressants-dangers" target="_self">featured in my column</a>.) For over three years, the crew followed five people (including Peacock) around as they dealt with the terrifying health consequences of medication dependence. </p><p>"These medicines are causing an epidemic of disability," Ratcliffe says. When I ask what she learned about the pharmaceutical industry while making the film, her eyes light up. She shakes her head in disbelief. </p><p style="margin-left: 20px;">"I'm totally shocked by the FDA process: medications that are designed to be taken for many years or even a lifetime, to get them approved they only have to be shown to work better than a placebo over three to six weeks. There is no obligation to test these drugs for long-term side effects. I was shocked to discover that pharmaceutical companies pay for most of the research on their own drugs. They design the research to get the result that they want. When they don't like the result of the trial, they throw it out."</p><p>Whitaker told me about the original trial for the benzodiazepine, Xanax. At four weeks, it outperformed the placebo. At eight weeks, however, there was no discernible difference between the placebo and Xanax. By 14 weeks, the placebo outperformed Xanax. To get around this inconvenient data, Upjohn only reported the four-week data. The FDA approved the drug. </p><p>That was in 1980. In 2017, <a href="https://www.statista.com/statistics/781816/alprazolam-sodium-prescriptions-number-in-the-us/" target="_blank">25 million Xanax prescriptions</a> were written. </p><p>Pharmaceutical companies understand how to get FDA approval. Like oil companies, they're clueless when tragedy strikes. They don't know how to deal with the long-term side effects of their drugs, so they ignore them. Ratcliffe says the doctors she talked with weren't trained in tapering protocols or educated about the negative impact of the drugs they prescribe. The reflexive response is another drug, not an honest investigation of the drugs themselves.</p>
Wendy Ratcliffe and Lynn Cunningham at the premiere of Medicating Normal at the Santa Barbara International Film Festival.
Credit: Wendy Ratcliffe<p>This is the process that led to Peacock being prescribed 18 drugs at once. The side effects, she confirms, are not minor.</p><p style="margin-left: 20px;">"From a patient standpoint, I thought dizziness meant I had to get up slowly. The dizziness I experienced coming off of antidepressants and benzodiazepines was like, I can't walk. It was like walking on the Grand Canyon in high heels on a tight wire."</p><p>Though the final benzodiazepine nearly killed her, Peacock finally abandoned all drugs in 2016. Today, she feels old parts of herself coming back, but she's not yet whole. She's not sure she'll ever be. Currently living in her RV, she travels around the country educating former vets and promoting the documentary. Unlike her time on prescription drugs, she now has a mission.</p><p>"The way we bring people home from war and then put them on drugs is not right," she says. She is doing her best to change that fact. </p><p>Both women agree on an important point: psychiatry needs informed consent. The problem, Ratcliffe says, is that "psychiatry lobbying groups feel that informed consent impedes their ability to prescribe." She compares the industry to the NRA: any criticism is treated as a potential keystone that, if removed, will take out the entire system. In reality, all patients are asking for is honesty about how these drugs interact in their bodies. </p><p>We don't know the long-term effects because pharmaceutical companies don't have to study them. If the industry isn't required to disclose these effects, and psychiatrists remain ignorant of the real damage being done to some of their patients, informed consent remains an intangible dream with no pathway to reality. </p><p>As Whitaker writes in "Anatomy of an Epidemic," antidepressants don't treat chemical imbalances—they create them. Over 2,500 years ago, doctors recognized melancholy as a natural part of life—one that, as Schuyler and others realized, goes away with time. Yet for a growing number of Americans, depression will never fade because they weren't informed about the potential consequences of the prescription they were handed. They never know what they're being told to swallow. </p><p>--</p><p><em>Stay in touch with Derek on <a href="http://www.twitter.com/derekberes" target="_blank">Twitter</a>, <a href="https://www.facebook.com/DerekBeresdotcom" target="_blank">Facebook</a> and <a href="https://derekberes.substack.com/" target="_blank">Substack</a>. His next book is</em> "<em>Hero's Dose: The Case For Psychedelics in Ritual and Therapy."</em></p>
An article in Journal of Bioethical Inquiry raises questions about the goal of these advocacy groups.
- Two-thirds of American consumer advocacy groups are funded by pharmaceutical companies.
- The authors of an article in Journal of Bioethical Inquiry say this compromises their advocacy.
- Groups like the National Alliance on Mental Illness act more like lobbyists than patient advocates.
The Corruption That Brought Prozac to Market — Robert Whitaker, Journalist<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="bea9cff2b25efc18b663a011a679ba16"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/UyaJExxFPAE?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>Consumer-oriented groups gained steam over the ensuing decades. Their efforts helped inspire the 1938 Food, Drug, and Cosmetic Act after over 100 people (mostly children) died from a sanctioned drug, Sulfanilamide. If not for the hard work of these advocates, this case might have been overlooked.</p><p>Early efforts also focused on the food industry, which was increasingly using chemical preservatives. The origin of Consumer Reports can be found in the consumer advocacy movement. Both the food and drug industries were getting a free pass to experiment on citizens with few repercussions.</p><p>These movements provided a social foundation for important advocacy work in the second half of the century. Female-led groups evolved to focus on women's reproductive rights, AIDS, and mental health. As the authors write, these groups struck a balance between working <em>with</em> and <em>against</em> current trends. Sometimes you need to craft legislation with officials; at other times, you have to rage against the machine with everything you've got. </p><p>Advocacy marked an important turning point in public health (and culture in general). These groups were tired of placating to a medical model that treated the male body as the standard. This wasn't limited to anatomy. As I <a href="https://bigthink.com/coronavirus/pandemic-warnings-rp-eddy" target="_self">wrote about last week</a>, a high-profile 1970s-era conference about the role of women on Wall St featured no women on stage. You can imagine what reproductive health looked like during that time. </p><p>Advocacy groups made real impact in public health. Then the money began pouring in. </p><p style="margin-left: 20px;">"These groups were funded largely by individual donations with some foundation support, but in the late 1980s, newer women's health groups moved to professionalize, effectively splitting the women's health movement."</p><p>A number of groups resist corporate ties to this day, such as the National Women's Heath Network and Breast Cancer Action. Too often, however, groups argue that their existence depends on corporate funding. This can lead to uncomfortable compromises. </p><p>An estimated two-thirds of patient advocacy groups in America accept funds from the pharmaceutical industry. Pharma companies gave <a href="https://link.springer.com/content/pdf/10.1007/s11673-019-09956-8.pdf" target="_blank">at least $116 million</a> to such groups in 2015 alone.</p><p>For example, over a three-year period, the National Alliance on Mental Illness (NAMI), which was founded by two mothers whose sons suffered from schizophrenia, received nearly $12 million from 18 pharmaceutical companies. The largest donor was Prozac manufacturer, Eli Lilly. By 2008, three-quarters of NAMI's budget was funded by the pharmaceutical industry. It gets worse:</p><p style="margin-left: 20px;">"An Eli Lilly executive was even 'on loan' to NAMI, paid by Eli Lilly, while he worked out of the NAMI office on 'strategic planning.'"</p>
A customer waiting for his medication at the Headache Bar in a pharmacy in Sydney, Australia. Among the items on sale are 'Paigees with Chlorophyll' and Alka Seltzer on tap.
Photo by Dennis Rowe/BIPs/Getty Images<p>This influx of cash skews public understanding of drugs. It also influences advocates to overlook real problems caused by pharmaceutical interventions, especially when it comes to mental health.<br></p><p>For a real-world example, consider how Xanax came to market. As journalist Robert Whitaker <a href="https://www.youtube.com/watch?v=2e829xdb4AA" target="_blank">explains</a>, an <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1463502/?page=1" target="_blank">initial study</a> was conducted to determine efficacy in treating panic attacks. After four weeks, Xanax was outperforming placebo, which is common with benzodiazepines over short-term usage. But it wasn't a four-week study; it was a 14-week study.</p><p>At the end of eight weeks, there was no difference in efficacy between Xanax and placebo.</p><p>At the conclusion of the study after 14 weeks, the placebo outperformed Xanax. By a lot.</p><p>Why is Xanax still prescribed for panic attacks? Because the pharmaceutical company, Upjohn, only published the four-week data. The 14-week data was not in its favor. Nearly forty years later, over <a href="https://www.statista.com/statistics/781816/alprazolam-sodium-prescriptions-number-in-the-us/" target="_blank">25 million</a> Americans receive a prescription despite its <a href="https://drugabuse.com/xanax/effects-use/" target="_blank">long list</a> of side effects and addictive profile. </p><p>As the authors note, many consumers are not aware of how advocacy groups are funded.</p><p style="margin-left: 20px;">"An international study of groups in the United States, United Kingdom, Australia, Canada, and South Africa found that the extent of relationships with industry was inadequately disclosed in websites that addressed ten health conditions: cancer, heart disease, diabetes, asthma, cystic fibrosis, epilepsy, depression, Parkinson's disease, osteoporosis, and rheumatoid arthritis."</p><p>That's a tangled web of relationships. Pharmaceutical industry funding negatively impacts the work advocacy groups should be focused on: protecting us. NAMI, for example, claims that as a "natural ally" to the pharmaceutical industry, it helps consumers access "all scientifically proven treatments." When the industry ignores evidence of long-term damage caused by its treatments, you have to wonder what's being advocated. </p><p>Although, as the authors conclude, that question is easy to answer. </p><p style="margin-left: 20px;">"Instead of drawing insights from patient experience to set organizational agendas and challenge industry agendas, today's groups are silent on high prices and drug harms, oppose efforts to regulate these basic rights, and demand access to drugs that challenge the safety and effectiveness."</p><p><span></span>--</p><p><em>Stay in touch with Derek on <a href="http://www.twitter.com/derekberes" target="_blank">Twitter</a>, <a href="https://www.facebook.com/DerekBeresdotcom" target="_blank">Facebook</a> and <a href="https://derekberes.substack.com/" target="_blank">Substack</a>. His next book is</em> "<em>Hero's Dose: The Case For Psychedelics in Ritual and Therapy."</em></p>
Should pharmaceutical companies pay people for their plasma? Here's why paid plasma is a hot ethical issue.
- Human blood is made up of red blood cells, white blood cells, platelets, and plasma. Plasma is the liquid part of blood. It is used to treat rare blood conditions and has an increasing number of medical applications.
- It is a $26 billion industry, and the US is a major exporter of plasma to other nations. Most nations do not collect enough plasma to sustain therapies for their own citizens. The US has such a large supply of plasma because it pays people to donate plasma—a controversial practice.
- Is it ethical for people to be paid for their plasma? Here, Peter Jaworski, an ethics scholar, explains five key arguments people make against paying people for plasma—safety, security, altruism, commodification, and exploitation—and explains his views on them. What do you think?