New study: Vaccine Manufacturers and FDA Regulators Used Statistical Gimmicks to Hide Risks of HPV Vaccines

New study: Vaccine Manufacturers and FDA Regulators Used Statistical Gimmicks to Hide Risks of HPV Vaccines
Source: GreenMedInfo.com
Robert F. Kennedy Jr.
August 13, 2017

Originally published on worldmercuryproject.org.

A new study published in Clinical Rheumatology exposes how vaccine manufacturers used phony placebos in clinical trials to conceal a wide range of devastating risks associated with HPV vaccines.

Instead of using genuine inert placebos and comparing health impacts over a number of years, as is required for most new drug approvals, Merck and GlaxoSmithKline spiked their placebos with a neurotoxic aluminum adjuvant and cut observation periods to a matter of months.

Researchers from Mexico’s National Institute of Cardiology pored over 28 studies published through January 2017—16 randomized trials and 12 post-marketing case series—pertaining to the three human papillomavirus (HPV) vaccines currently on the market globally. In their July 2017 peer-reviewed report, the authors, Manuel Martínez-Lavin and Luis Amezcua-Guerra, uncovered evidence of numerous adverse events, including life-threatening injuries, permanent disabilities, hospitalizations and deaths, reported after vaccination with GlaxoSmithKline’s bivalent Cervarix vaccine and Merck’s quadrivalent or nine-valent HPV vaccines (Gardasil and Gardasil 9). Pharmaceutical company scientists routinely dismissed, minimized or concealed those injuries using statistical gimmicks and invalid comparisons designed to diminish their relative significance.

Of the 16 HPV vaccine randomized trials, only two used an inert saline placebo. Ten of the sixteen compared the HPV vaccine against a neurotoxic aluminum adjuvant, and four trials used an already-approved aluminum-containing vaccine as the comparison.

Scientific researchers view double-blind placebo trials as the gold standard for testing new drugs. To minimize bias, investigators randomly assign patients to either a “treatment” group or a “control” (placebo) group and then compare health outcomes. The standard practice is to compare a new drug against a “pharmacologically inert” placebo. To minimize opportunities for bias, neither patients nor researchers know which individuals received the drug and which the placebo. However, in clinical trials of the various HPV vaccines, pharmaceutical researchers avoided this kind of rigor and instead employed sleight-of-hand flimflams to mask the seriousness of vaccine injuries.

Of the 16 HPV vaccine randomized trials, only two used an inert saline placebo. Ten of the sixteen compared the HPV vaccine against a neurotoxic aluminum adjuvant, and four trials used an already-approved aluminum-containing vaccine as the comparison. One does not have to be a scientist to understand that using aluminum-containing placebos is likely to muddy the comparison between the treatment and control groups. Critics of the HPV vaccine have pointed to the aluminum adjuvant as the most likely cause of adverse reactions, and some researchers have questioned the safety of using aluminum adjuvants in vaccines at all, due to their probable role as a contributor to chronic illness. The aluminum-containing placebos appeared to provoke numerous adverse reactions among the presumably unwitting patients who received them, allowing the pharma researchers to mask the cascade of similar adverse reactions among the groups that received the vaccines. Although both placebo and study groups suffered numerous adverse events in these studies, there were minimal differences between the two groups. The similar adverse outcomes in both groups allowed industry researchers and government regulators to claim that the vaccines were perfectly safe, despite manifold disturbing reactions. The Mexican researchers’ meta-review confirms the difficulty of ascertaining vaccine-attributable differences from this mess; the researchers identified only a few indications of “significantly increased systemic adverse events in the HPV vaccine group vs. the control group” across the 16 pre-licensure trials.

The HPV promoters found it more difficult to employ deceptive devices in the 12 post-marketing safety reviews, and the Mexican authors summarize some of the more noteworthy findings. In Spain, they found a ten-fold higher incidence of vaccine-related adverse events following HPV vaccination compared to “other types of vaccines.” In Canada, they found an astonishing one in ten rate of hospital emergency department visits among HPV-vaccinated individuals “within 42 days after immunization.” Still, the industry researchers did what they could to minimize these injuries. The Mexican reviewers criticize the authors of the various post-marketing studies for failing to ask essential questions, to evaluate the many serious adverse events, or to elaborate on their often-troubling findings.

Abbreviated Trial Times

Typically, FDA requires drug companies seeking approval for a new drug to observe health outcomes in both the placebo and study groups for 4-5 years. Vaccine manufacturers take advantage of FDA regulatory loopholes that allow fast-tracking of vaccines and cut that period down to a few weeks or even a few days. This means that injuries that manifest, or are diagnosed, later in life—most neurodevelopmental disorders, for example—will escape attention entirely.

Further Smokescreens

Martínez-Lavin and Amezcua-Guerra point to clinical trial data posted on the FDA webpage for the quadrivalent Gardasil vaccine approved in 2006. Those clinical trials deployed a panoply of the kind of cunning deceptions used by industry and government researchers. Unlike many of the other HPV vaccine clinical trials, these clinical studies employed a true saline placebo.

Across the Gardasil clinical studies, a group of 15,706 females ages 9-45 and males ages 9-26 received the quadrivalent Gardasil vaccine. A control group of 594 individuals received an inert saline placebo. The industry researchers never explain the tiny relative size of the saline placebo group; it’s noteworthy that small size would have the effect of keeping unwanted signals weak. But a second control group of 13,023 received a so-called “spiked” placebo loaded with an aluminum adjuvant (amorphous aluminum hydroxyphosphate sulfate or AAHS). The large size of this “spiked placebo” group suggests that the decision to keep the saline placebo group small was strategic.

Putting aside the thorny ethical question of whether study participants were told that they were being injected with a neurotoxin with probable associations with Alzheimer’s, dementia and other forms of brain disease, the inclusion of both saline and aluminum placebos provided these researchers a chance to do some genuine science. But the FDA webpage shows the troubling gimmick that was then employed by the FDA and Merck, which seems deliberately designed to blur datasets in order to mask adverse effects during the clinical trials. The table showing relatively minor injection-site adverse reactions—one to five days post-vaccination—displays three distinct columns for the three groups: Gardasil recipients, the aluminum “placebo” recipients, and saline placebo recipients (see table below). In the table, “Intergroup differences are obvious,” in the words of the Mexican researchers. For example, roughly three and a half times more girls/women experienced injection site swelling in the Gardasil group compared to the saline group (25.4% vs. 7.3%). In fact, by all five measures, both the Gardasil recipients and the aluminum placebo recipients fared two to three times worse than the saline recipients.

New study: Vaccine Manufacturers and FDA Regulators Used Statistical Gimmicks to Hide Risks of HPV Vaccines

When it came time for Merck to report on the occurrence of more serious reactions, “Systemic Adverse Reactions” and “Systemic Autoimmune Disorders,” for example, the company scientists switched to a very different format. In these tables, the third column that reported results for the saline placebo recipients disappears. Instead, Merck combined the groups receiving the spiked aluminum placebo into a single column with the group receiving the genuine saline placebo (see example below). The merger of the two control groups makes it impossible to compare results for Gardasil versus the saline placebo or the aluminum placebo versus the saline placebo. In this way, Merck’s researchers obliterated any hope of creating a meaningful safety comparison.

New study: Vaccine Manufacturers and FDA Regulators Used Statistical Gimmicks to Hide Risks of HPV Vaccines

Risks and Benefits

Given aluminum’s known neurotoxicity and its association with debilitating autoimmune conditions, it is unsurprising that there are no observable differences between the Gardasil and AAHS/saline groups. But, despite the researchers’ efforts to paper over adverse effects, they were not able to conceal the devastating health injuries to their human guinea pigs. The bottom line of these trials reveals a shocking truth: An alarming 2.3% of both their study and control groups had indicators of autoimmune diseases! These data are even more alarming when one considers that the observation period was curtailed after only six months. With this level of risk, it would seem that no loving parents would allow their daughter to receive this vaccine—particularly given the comparatively low risk posed by HPV in countries with appropriate cervical cancer screening tests. Even in countries such as India, where cervical cancer mortality is high due to late detection, leading Indian physicians argue that comprehensive screening should be the country’s top priority rather than the “panacea” of HPV vaccination.

Consider the math: According to the National Institutes of Health (NIH), an estimated 2.4 women per 100,000 die of cervical cancer in the US each year. On the other hand, the FDA’s Table 2 (above) shows that 2.3 per 100girls and women developed an “incident condition potentially indicative of a systemic autoimmune disorder” after enrolling in the Gardasil clinical trial. It is difficult to understand how any rational regulator could allow more than two in 100 girls to run the risk of acquiring a lifelong autoimmune disorder, particularly when Pap smears are already doing an effective job of identifying cervical abnormalities. The NIH notes that the incidence and death rates for cervical cancer in the US declined by more than 60% after introducing Pap smear screening.

Based on the numerical outcomes of that study, the Mexican researchers calculated the likelihood of being actually “helped or harmed by the 9-valent HPV vaccine.” Their “worrisome” finding is that the “number needed to harm” is just 140, whereas 1757 women would need to receive the vaccine for a single one of them to enjoy its projected benefits.

Martínez-Lavin and Amezcua-Guerra make their own effort to illustrate the zany risk-benefit ratios associated with these vaccines when discussing the results of one of the 16 clinical trials. That study compared approximately 14,000 women who received either Gardasil 9 or the original quadrivalent Gardasil. Based on the numerical outcomes of that study, the Mexican researchers calculated the likelihood of being actually “helped or harmed by the 9-valent HPV vaccine.” Their “worrisome” finding is that the “number needed to harm” is just 140, whereas 1757 women would need to receive the vaccine for a single one of them to enjoy its projected benefits.

Implications for Aluminum Adjuvants

Merck found that astronomical casualty counts were equal among both Gardasil and aluminum “placebo” recipients. The inescapable implication is that aluminum adjuvants may be a principal culprit in the flood of injuries reported for the various HPV vaccines. This conclusion, if true, requires reevaluation of the use of aluminum adjuvants in several other vaccines, including some given to infants. Aluminum adjuvant levels have mushroomed since the 2003 removal of thimerosal from three pediatric vaccines. The following chart, prepared by Dr. Sherri Tenpenny, illustrates the stunning amount of aluminum in vaccines.

New study: Vaccine Manufacturers and FDA Regulators Used Statistical Gimmicks to Hide Risks of HPV Vaccines

Multiple peer-reviewed studies have connected aluminum exposures to a range of autoimmune and neurological disorders, including dementia and Alzheimer’s disease, that have become epidemic coterminous with these aluminum exposures. A review in the European Journal of Clinical Nutritionwarns of dangerous accumulation of aluminum in the brain when, as in the case of vaccination, “protective gastrointestinal mechanisms are bypassed.” It’s time to go back to the drawing board on HPV vaccines and aluminum adjuvants. More importantly, FDA needs to start requiring the same rigorous pre-licensing safety testing for vaccines that it has long required for other drugs. All existing vaccines, particularly those containing aluminum, should be safety-reviewed according to these more stringent standards.

Learn more from RFK, Jr., and 30 other experts at the free screening of the Truth About Vaccines.

Read More At: GreenMedInfo.com

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Dr. Mercola and Dr. Osmunson on the Dangers of Fluoride

Source: Mercola.com
Dr. Mercola
June 7, 2017

Natural health expert and Mercola.com founder Dr. Joseph Mercola interviews Dr. Bill Osmunson about the dangers associated with water fluoridation. To find out more, visit Mercola.com.

Flint residents must pay for poison water or face foreclosure

Source:  RT
May 7, 2017

The city of Flint, Michigan has mailed more than 8,000 letters to residents, trying to collect $5.8 million in unpaid water bills. Flint resident Melissa May says the water she is being asked to pay for is “blue” and contains neurotoxins. Meanwhile, residents who do not pay up face foreclosure. RT America’s Natasha Sweatte has the story.

No study exists to show that vaccine ingredient Thimerosal is safe

Image: No study exists to show that vaccine ingredient Thimerosal is safe

Source: NaturalNews.com
Ethan Huff
February 21, 2017

You probably caught the big news last week that President Trump’s new commissioner on vaccine safety, Robert F. Kennedy, Jr., has issued a formal challenge: if anyone can find even a single credible study out there showing that the mercury derivative Thimerosal, which is added to influenza and other vaccines, is safe, then he or she will receive $100,000 in cash. Well, a good chunk of time has passed since this offer was issued and, sure enough, nobody has claimed the prize because no such study exists.

It’s something we’ve been saying here at Natural News for a long time about the chemicals that millions of people are injecting into their children. It’s also the subject matter of the critically-acclaimed documentary film Vaxxed: From Cover-Up to Catastrophe, which the Tribeca Film Festival pulled from its lineup at the behest of the militant vaccine mafia. But all this censorship and bullying hasn’t stopped the truth about the dangers of vaccine ingredients like Thimerosal from spreading. (RELATED: See how current law prevents parents from suing vaccine manufacturers for injury at AgeOfAutism.com)

In a recent joint letter issued by Kennedy and De Niro to American journalists, the duo reiterates the World Mercury Project’s $100,000 challenge, urging journalists, reporters, columnists, editors, network anchors, on-air doctors, news division producers, and anyone else out there with sway and influence to take them up on the offer. By simply doing the type of digging that journalists used to do before they became co-opted by special interest corruption, today’s journalists have a once-in-a-lifetime chance to bank some serious cash, should they be so willing and brave.

“Despite the cascade of recent science confirming that thimerosal is a potent neurotoxin that damages children’s brains, the American media has fiercely defended the orthodoxy that mercury-based vaccines are safe,” Kennedy and De Niro write in their open letter. “We believe that even a meager effort at homework will expose that contention as unsupported by science.”

If nobody claims $100,000 prize, this will prove that mercury in vaccines is NOT safe

Much of the problem lies in the fact that today’s faux journalists are told what to do by their higher-ups in a way that keeps critical information like vaccine safety out of the limelight. The public tends to believe what these faux journalists say — or in this case, don’t say — because, surely someone would get the scoop if given the opportunity, right? Unfortunately, this isn’t the case, and there is far more censorship going on than many people would choose to believe.

That’s what makes this Thimerosal challenge so important: it forces the hand of the powers that be to either put up or shut up. If there’s evidence out there that mercury derivatives are safe in childhood vaccines, then somebody is going to present it to jump on that $100,000. If this evidence doesn’t exist and nobody claims the cash, then it will be apparent to everyone that agencies like the U.S. Centers for Disease Control and Prevention (CDC) have been lying to the public as whistleblowers like Dr. William Thompson have been claiming.

“Journalists, we have discovered — even science and health journalists — don’t always read the science!” the joint letter adds. “On the vaccine issues, many of them have let government and industry officials tell them what the science supposedly says. Instead of questioning, digging and investigating, journalists, too often, have taken the easy course of repeating the safety assurances of the pharmaceutical industry and the regulators at CDC’s Immunization Safety Office, which they have good reason to doubt.”

Read More At: NaturalNews.com

Sources:

EcoWatch.com

Pittsburgh.CBSLocal.com

WorldMercuryProject.com

YouTube.com

BREAKING BREAKING NOW: ROBERT DE NIRO AND ROBERT KENNEDY HOLDING PRESS CONFERENCE NOW ANNOUNCING TOXIC MERCURY IN VACCINES

vaccines
Source: NoMoreFakeNews.com | JonRappoport.wordpress.com
Jon Rappoport
February 15, 2017

8:50AM EST…

DEVELOPING… I’ve just received word that, in a few minutes, at the National Press Club, in Washington DC, Robert De Niro and Robert F Kennedy Jr. are issuing a challenge to all media and all scientists…

They will give $100,000 to anyone who can show one published study that proves mercury in flu vaccines—at the levels it is injected—is safe.

The press conference will begin at 9:15am EST.

This is named THE WORLD MERCURY PROJECT CHALLENGE.

Will the press conference be broadcast? That’s up to the media attending. Will they have the guts?

I’m told that CNN backed out of attending the press conference, and now they’re in again…

Del Bigtree, producer of the film Vaxxed (trailer), will also speak at the press conference.

Kennedy states that Trump contacted him to head up a commission investigating vaccine safety. According to Kennedy, Trump said he knew he was going up against Big Pharma, but he was ready for the battle.

At this moment, De Niro and Kennedy are sitting in a small broadcast room at the Press Club, waiting to start. No one knows how many press outlets are going to show up….

Stay tuned.

Read More At: JonRappoport.wordpress.com
_______________________________________________________________

Jon Rappoport

The author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX, Jon was a candidate for a US Congressional seat in the 29th District of California. He maintains a consulting practice for private clients, the purpose of which is the expansion of personal creative power. Nominated for a Pulitzer Prize, he has worked as an investigative reporter for 30 years, writing articles on politics, medicine, and health for CBS Healthwatch, LA Weekly, Spin Magazine, Stern, and other newspapers and magazines in the US and Europe. Jon has delivered lectures and seminars on global politics, health, logic, and creative power to audiences around the world. You can sign up for his free NoMoreFakeNews emails here or his free OutsideTheRealityMachine emails here.

Robert F. Kennedy, Jr. and Robert De Niro Hold Press Conference Today at The National Press Club

The event this morning will focus on the announcement of a unique challenge: to find a missing piece of research associated with mercury, a neurotoxin that is 100 times more poisonous than lead. There’s a substantial cash award involved, the details of which will be revealed.

Robert F. Kennedy, Jr. and Robert De Niro Hold Press Conference Today at The National Press Club
[Editor’s Note]

For those seeking additional information on mercury being a neurotoxin, please read the review of Robert F. Kennedy Jr.’s book:

Thimerosal – Let The Science Speak – The Evidence Supporting The Immediate Removal Of Mercury – A Known Neurotoxin – From Vaccines by Robert F. Kennedy

__________________________________________________________

Source: GreenMedInfo.com
Robert F. Kennedy Jr.
February 15, 2017

FOR IMMEDIATE RELEASE

Contact:

202-854-1310, Laura.Bono@WorldMercuryProject.org

Robert F. Kennedy, Jr. and Robert De Niro Hold Press Conference Today at The National Press Club

WASHINGTON, Feb. 15, 2017 – The event this morning will focus on the announcement of a unique challenge: to find a missing piece of research associated with mercury, a neurotoxin that is 100 times more poisonous than lead. There’s a substantial cash award involved, the details of which will be revealed.

Kennedy will also answer questions on President Trump’s vaccine safety commission.

De Niro supports the mission of the World Mercury Project (WMP), a nonprofit public advocacy organization in which Kennedy serves as Chairman. The WMP envisions a world where mercury is no longer a threat to the health of our planet and people.

The event, in the Holeman Lounge of The National Press Club, starts at 9:25 a.m. with excerpts from a movie. The conference, including Q&A period, is from 10-11 a.m.

It will also be livestreamed beginning at 10:00 ET on the WMP’s Facebook page and on its website.

Recent Articles by Robert F. Kennedy Jr.

Mounting Evidence Links Lead, Mercury and Arsenic to Autism

Mercury, Vaccines and the CDC’s Worst Nightmare

Should I Get the Flu Shot? CDC Data Raise Concerns

New Study Confirms That Mercury Is Linked to Autism

Robert F. Kennedy, Jr. Launches The World Mercury Project

CDC Blocks Testimony by Vaccine Whistleblower in Medical Malpractice Case

African-American Autism and Vaccines: RFK Jr.

Related Articles on Vaccinations

Dirty Vaccines: Every Human Vaccine Tested Was Contaminated With Metals and Debris in New Study

The Microbiome and the Vaccine Industry

Rob Schneider’s Uncensored Press Release On Vaccination

Colostrum Three Times More Effective than Flu Vaccine

End Pharma Liability Shield Endangering Public Health and Human Rights

200 Evidence-Based Reasons NOT To Vaccinate – FREE Research PDF Download!

Read More At: GreenMedInfo.com
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Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.

New Vaccine Study: Many Toxic Heavy Metal & Red Blood Cell Contaminants Found

Source: GizaDeathStar.com
Dr. Joseph P. Farrell Ph.D.
February 12, 2017

From time to time we have been following the vaccine story and the increasing scrutiny that they are under.

And for good reason, for consider the following the story that Mssrs. P.H., V.T. and many other shared this week (and you may want to sit down):

Dirty Vaccines: New Study Reveals Prevalence of Contaminants

The release of this information as the Trump Administration is considering the appointment of Robert F. Kennedy JR to head a panel to investigate them and the pharmaceutical companies behind them is timely, and perhaps, even deliberate. But the real news here is what is in these vaccines. Note the following paragraphs:

Using extremely sensitive new technologies not used in vaccine manufacturing, Italian scientists reported they were “baffled” by their discoveries which included single particles and aggregates of organic debris including red cells of human or possibly animal origin and metals including lead, tungsten, gold, and chromium, that have been linked to autoimmune disease and leukemia.

In the study, published this week in the International Journal of Vaccines and Vaccination, the researchers led by Antonietta Gatti, of the National Council of Research of Italy and the Scientific Director of Nanodiagnostics, say their results “show the presence of micro- and nano-sized particulate matter composed of inorganic elements in vaccine samples” not declared in the products’ ingredients lists.

Lead particles were found in the cervical cancer vaccines, Gardasil and Cervarix, for example, and in the seasonal flu vaccine Aggripal manufactured by Novartis as well as in the Meningetec vaccine meant to protect against meningitis C.

Samples of an infant vaccine called Infarix Hexa (against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and haemophilus influenzae type B) manufactured by GlaxoSmithKline was found to contain stainless steel, tungsten and a gold-zinc aggregate.

Other metal contaminants included platinum, silver, bismuth, iron, and chromium. Chromium (alone or in alloy with iron and nickel) was identified in 25 of the human vaccines from Italy and France that were tested.

Observe that this study was conducted by the Italian National Council of Research, and hence, is not so easily dismissed by the Center for Disease Control or by corporate shills. And also observe the list of what was found: unidentifiable red blood cells, lead, tungsten, gold, chromium, stainless steel, zinc, platinum, silver, bismuth, iron, and nickel. All we’re missing is a little thorium toothpaste (that’s a joke for those who’ve been following my interviews over the years), and a dash of uranium. But seriously, the list is far from complete. There is a growing body of criticism that has maintained that vaccines also contain human stem cells (from aborted babies), and so on. And let’s not leave out aluminum:

The investigation revealed aluminum and sodium chloride, the usual component of saline, as was expected, because they are named ingredients of most vaccines. …

Aluminum has a documented neurotoxicity all by itself. The French veterinary vaccines exclude it for this reason. The human ones don’t. (Emphasis added)

Ponder that: in France, veterinary vaccines are prohibited from containing aluminum, but human ones aren’t… a disturbing factoid, since there are also studies linking aluminum to Alzheimer’s(that’s that “documented neurotoxicity” part, perhaps).

So what’s the problem? In mentioning the presence of aluminum, the Italian researchers go on to mention a very significant point, one which we have observed here in prior blogs about vaccines and, incidentally, about GMOs:

Aluminum has a documented neurotoxicity all by itself. The French veterinary vaccines exclude it for this reason. The human ones don’t. The researchers express concern about synergy of multiple toxins added to this known neurotoxin. “It is a well-known fact in toxicology that contaminants exert a mutual, synergic effect, and as the number of contaminants increases, the effects grow less and less predictable. The more so when some substances are unknown.” (Emphases added)

It’s that “mutual, synergistic effect” that should make everyone sit up and take notice, for what this really means is that while the effects of individual contaminants are fairly well known, their effects when working in combination multiply synergistically, and by dint of that, have effects that are geometrically multiplied and that are not well understood.

What’s the bottom line? Well, for one thing, I suspect it won’t be long before “Big Pharma” – and let’s call them what they really are: I.G. Farbensanto – will realize they’re missing a golden opportunity to harvest even more wealth from people, and start contaminating animal vaccines as well, and reaping enormous profit from suffering animals and their owners, and then proffer even more drugs as “cures”, for a hefty price, of course. And as for humans, I don’t know about you, but I strongly suspect the omission of these contaminants from their vaccine labels is not accidental.

They… just… don’t… care.

See you on the flip side.

Read More At: GizaDeathStar.com
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About Joseph P. Farrell

Joseph P. Farrell has a doctorate in patristics from the University of Oxford, and pursues research in physics, alternative history and science, and “strange stuff”. His book The Giza DeathStar, for which the Giza Community is named, was published in the spring of 2002, and was his first venture into “alternative history and science”.