Universal Vaccinations for Children will be Overseen by Committee which Accepts Vaccine Manufacturer Monies
A House of Representatives Bill, short titled “Vaccinate All Children Act of 2015,” has been referred to the Subcommittee on Health and is awaiting committee action.
HR 2232 was introduced by Frederica Wilson, Democrat from Florida and is largely modeled on the California student vaccination act, which was signed into law by Governor Jerry Brown in June of this year.
Like the California Act, HR 2232 removes all previous exemptions from vaccination, other than a medical exemption, supported by a medical doctor’s statement that a particular vaccination would be hazardous to a specific child’s well- being. Gone are the religious exemptions and philosophical exemptions.
Previously, forty-eight states had laws on the books honoring religious exemptions and nineteen states allowed philosophical exemptions.
This Act would override any state law governing vaccine exemptions, making it mandatory for all students at public elementary and secondary schools to be vaccinated. The bill would amend the Public Health Services Act to require students “to be vaccinated in accordance with the recommendations of the Advisory Committee on Immunization Practices.” (ACIP)
The bill does not, however, reveal which vaccinations would be mandatory nor does it place a cap on vaccinations.
The above cited Advisory Committee, which will be making the decisions concerning which shots are mandatory, is stacked with pro-vaccination heavyweights. Notable committee members include a Dr. Kelly Moore, Director, Tennessee Immunization Program, Dr. Edward Belongia, Director, Center for Clinical Epidemiology & Population Health at the Marshfield Clinic Research Foundation and Dr. Kathleen Harriman, Chief, Vaccine Preventable Disease Epidemiology Section with the California Department of Public Health, to name a few. Also sitting on the Committee as Ex Officio members are Department of Defense (DoD) officials as well as FDA officials and members of the Department of Veterans Affairs, among representatives from other federal agencies.
Dollars for Docs
A close scrutiny of this Advisory Committee reveals that quite a number of its members are enriching themselves through vaccine industry “donations” or grants.
For example, some of these individuals have a history which includes industry sponsorship or employment. An example is Dr. Belongia, who has been listed as Co-Principal Investigator for an industry sponsored study of effectiveness of quadrivalent influenza vaccine in children.
According to Propublica, a number of these vaccine experts on the Advisory Committee are accepting large sums of vaccine company money. Dr. Gregory Poland, who is with the American College of Physicians and also the Mayo Clinic, has received a total of $17,351.00 from vaccine manufacturers Novartis Vaccines and Sanofi Pasteur. The money changed hands, according to Propublica, for activities by Dr. Poland listed as promotional speaking, consulting and travel and food expenses from November 2013 through December 2014.
Dr. Stanley Grogg, a “Liaison Member” of the Committee and with American Osteopathic Association (AOA), was rewarded for his “promotional speaking” activities, as well as “consulting,” “travel and lodging” and of course the ubiquitous “food and beverage” — to the tune of $60,391.00. These payments were made during the period of August 2013 through December 2014 and came from a buffet of pharmaceutical companies, including Pfizer, Sanofi, Novartis Vaccines and GlaxoSmithKline, among others.
Dr. Kenneth Schmader is listed as a “Liaison Member” of the ACIP, due to his position with the American Geriatrics Society (AGS). He is a Professor of Medicine-Geriatrics and Geriatrics Division Chief at Duke University and Durham VA Medical Centers in Durham, NC. Dr. Schmader received $75,913.79 for research, paid by Merck, Sharp and Dohme Corporation during the program year 2014.
Dr. Carol Baker, a “Liaison member” and with Infectious Diseases Society of America (IDSA) , also works as a Professor of Pediatrics with the Baylor College of Medicine in Houston, Texas. Dr. Baker was also found to have received $37,514.00 from August 2013-December 2014 for speaking, consulting, lodging and eating. The usual suspects pop up as the vaccine manufacturers who contributed to Dr. Baker—Novartis and Pfizer making the majority of the contributions.
Not to be left in the dust, Dr. William Schaffner, a “Liaison Member” from the National Foundation for Infectious Diseases (NFID) and the Chairman, Department of Preventive Medicine, Vanderbilt University School of Medicine, received a total payment of $26,208 in the two year period from Pfizer and Sanofi Pasteur. The total paid Dr. Schaffner for travel and lodging came to $13,653.00.
Committee member Dr. Ruth Karron, who is listed as Professor and Director at the Center for Immunization Research, Department of International Health at Johns Hopkins Bloomberg School of Public Health in Baltimore, received $ $7,173 from GlaxoSmithKline for consulting from April-December, 2009, while Dr. Lee Harrison of Pittsburgh was paid a total of $27,663.00 by Glaxo and Pfizer, from 2009-2012.
Besides direct payments to pro- vaccine committee members from the pharmaceutical companies, there are other revenue streams gracing ACIP committee members. While this reporter did not find evidence that Advisory Committee member Dr. Arthur Reingold had received the above types of monies from Big Pharma, his name surfaced in connection with an effort to shut down a Professor whose work challenged the conventional wisdom that AIDS was mortally impacting large numbers of Africans. Reingold was assigned to “investigate” professor Peter Duesberg for “misconduct,” surrounding Duesberg’s findings that figures on AIDS deaths in Africa had been deliberately inflated.
As it turned out, Dr. Arthur Reingold had received over $37 million for AIDS research since 1988. Professor Duesberg was subsequently exonerated of the charges.
Dr. David Stephens, a voting member of the Committee, also did not show up on the Propublica list of doctors who took money from pharmaceutical companies. Stephens, whose bio states he has “led research initiatives in the School of Medicine” (at Emory University), is responsible for Emory researchers receiving “$521.8 million from eternal funding agencies in fiscal year 2014.”
Stephens also hobnobs with the Vaccine Dinner Club, which exists to “advance the practice of vaccine science by stimulating the intellectual potential and research productivity of the vaccine research community in the Southeast…”
Dinners and membership in the club are free, sponsored by Emory University and other organizations. I guess with a half billion dollars knocking around in your pocket, a free lunch for your fellow scientists wouldn’t be much of an issue.
Stephens also sits on the Board of Directors for Georgia Bio, a non-profit organization dedicated to advancing the growth of Georgia’s life sciences industry. Also represented on the Georgia Bio Board are vaccine manufacturers and pharmaceutical companies: Johnson and Johnson, Geovax, Arbor Pharmaceuticals, Immucor, Osmotica Pharmaceutical Company and Femasys.
Georgia Bio was contacted by this reporter, who wished to query what, if any, compensation Stephens received for his service on the Board. Jennifer Kauffman, Development Director, promptly hung up rather than answer.
Should HR 2232 be approved by the US Congress, it is this Advisory Committee which will decide which vaccinations American children must receive. The clear conflict of interest inherent in Committee members padding their wallets with money from the pharmaceutical industry realistically should disqualify the members from making these critical decisions.
These conflicts of interest are not new for the ACIP. As reported over fifteen years ago by the National Vaccine Information Center, previous conflicts of interest ranged from the ACIP chairman owning stock in vaccine giant Merck, to other financial ties between committee members and vaccine companies. In addition, the National Vaccine Information Center reported that the mandated financial disclosures filed by committee members were incomplete, rendering a full accounting of their financial relationships with pharmaceutical companies difficult, if not impossible.
Regarding the compensation paid by the CDC to ACIP members, CDC reports that;“Appointments are not remunerated. However, members are compensated for expenses incurred by attendance at meetings. Such compensation, which includes the issuance of airline tickets, per diem to cover lodging, meals and incidental expenses will be in accordance with DHHS/CDC travel rules. An optional honorarium of $250/day for each day that a member attends an ACIP meeting is offered to voting members, who are designated as Special Government Employees during their tenure on the Committee.”
Radio show host (Wise Women Media) Anita Stewart contributed research to this report. This reporter requested that Stewart contact the CDC to query what sort of compensation the ACIP members received, as the CDC will no longer respond to public records or media requests from this reporter. This blacklisting took place following the publication of an article in Activist Post, indicating that the CDC was deflating the numbers of biological weapons labs.
Stewart, who located the above information on ACIP compensation online, was questioned by CDC media officer Sonny Dill, who kept insisting that Stewart was I. Dill also wanted to know who Stewart worked for, stating this information was necessary before answering any questions. Stewart, who was forthcoming in response, reports that Dill declined to supply the information requested.
One can easily see in the emerging information and cyber war that a nation having its own IT infrastructure, its own hardware, and its own versions of social media platforms is quickly becoming a matter of national security. Without control over these assets, a nation must depend on foreign suppliers for their computers, peripheries and software. Already, this dependence has opened nations up to now evident threats including malware embedded into hardware and software that is otherwise impossible to detect until the damage is already done.
Likewise, a nation’s food supply can and has throughout history, been a source of vulnerability in times of conflict. The inability to grow one’s own food invites blockades and their modern equivalent, sanctions, undermining a nation’s strength and stability and eventually setting the stage for its ultimate demise. Iraq is an example of this.
In the long-term, a nation’s food supply controlled by foreign corporations, particularly in the realm of genetically engineered organisms, can have disastrous effects. As a nation’s wealth is slowly drained from their shores and into the coffers of corporations like Bayer, Monsanto and Syngenta, inferior, expensive and environmentally devastating crops wreak havoc on the very socioeconomic fabric of a nation. India is increasingly becoming an example of this.
And what of healthcare? Surely the same applies. But even as nations and communities are just now understanding the importance of protecting their food supplies from predatory multinational corporations and the hegemonic ambitions they represent, there seems to be some latency in understanding this likewise in regards to healthcare and in particular pharmaceuticals and vaccines.
The Danger of Big-Pharma’s Vaccines
Imagine a gang member knocking at your door with a syringe in one hand, demanding you roll up your sleeve and allow him to inject its contents into your bloodstream. Likely there would be no hesitation to call the police and barricade the door until they arrived. Allowing a criminal to inject a substance known or unknown into your body would be an unimaginable risk no sane person would accept.
Now imagine that gang member is wearing a suit, has a multi-million dollar marketing budget, doctors and researchers working for him (paid via an expansive bribery network) and instead of knocking at your door, he invited you to one of his doctors’ offices to receive the injection. What we’ve just done here is describe big-pharma.
Immense pharmaceutical corporations like GlaxoSmithKline (GSK) have been caught numerous times engaged in immense criminality.
In 2012, the London Guardian would report in its article GlaxoSmithKline fined $3bn after bribing doctors to increase drugs sales that:
The pharmaceutical group GlaxoSmithKline has been fined $3bn (£1.9bn) after admitting bribing doctors and encouraging the prescription of unsuitable antidepressants to children. Glaxo is also expected to admit failing to report safety problems with the diabetes drug Avandia in a district court in Boston on Thursday.
The company encouraged sales reps in the US to mis-sell three drugs to doctors and lavished hospitality and kickbacks on those who agreed to write extra prescriptions, including trips to resorts in Bermuda, Jamaica and California.
In early 2014, the London Telegraph would report in its article GlaxoSmithKline ‘bribed’ doctors to promote drugs in Europe, former worker claims that:
GlaxoSmithKline, Britain’s largest drug company, has been accused of bribing doctors to prescribe their medicines in Europe.
Doctors in Poland were allegedly paid to promote its asthma drug, Seretide, under the guise of funding for education programme, a former sales rep has claimed.
Medics were also said to have been paid for lectures in the country which did not take place.
Then in late 2014, the BBC would report in its article GlaxoSmithKline fined $490m by China for bribery that:
China has fined UK pharmaceuticals firm GlaxoSmithKline $490m (£297m) after a court found it guilty of bribery.
The record penalty follows allegations the drug giant paid out bribes to doctors and hospitals in order to have their products promoted.
The court gave GSK’s former head of Chinese operations, Mark Reilly, a suspended three-year prison sentence and he is set to be deported.
These three news stories establish without doubt that an immense pharmaceutical giant, still allowed to conduct business to this very day, has been engaged in systematic, global criminality. The first story regarding its criminal conduct in the United States should be of particular concern, where the pharmaceutical giant encouraged doctors to peddle harmful substances to children. How exactly is that any different than your local pusher?
And it should be alarming to know that GSK is one of several pharmaceutical giants promoting the use of vaccines. Who would trust vaccines produced and peddled by the same corporation convicted multiple times of immense fraud, corruption and the endangerment of children?
But corrupt corporations peddling poison for profits still isn’t the greatest danger. State sanctioned bioweapons masquerading as vaccines is.
South Africa’s Vaccines Against “Being Black”
The apartheid regime in South Africa infamously waged war on its black population. So intent was the regime on subduing and/or exterminating black communities, its biological warfare program began developing a bioweapon that would infect only blacks, and planned to administer it covertly under the cover of a vaccine program.
The United Nations in a report titled Project Coast: Apartheid’s Chemical and Biological Warfare Programme would admit:
One example of this interaction involved anti-fertility work. According to documents from RRL [Roodeplaat Research Laboratories], the facility had a number of registered projects aimed at developing an anti-fertility vaccine. This was a personal project of the first managing director of RRL, Dr Daniel Goosen. Goosen, who had done research into embryo transplants, told the TRC that he and Basson had discussed the possibility of developing an anti-fertility vaccine which could be selectively administered—without the knowledge of the recipient. The intention, he said, was to administer it to black South African women without their knowledge.
Unscrupulous corporations with global reach, married to unscrupulous ideologies seeking to covertly kill off entire segments of their population constitutes nightmare scenarios generally confined to the realm of science fiction. However, here are the ingredients, right before our very eyes.
Vaccines and National Security
It is very clear then, why communities and nations must take control of their healthcare systems entirely. Not a single aspect of it can depend on foreign suppliers any more than national IT infrastructure, the food supply, power production, or military hardware can.
No nation would “outsource” the protection of its head of state to foreigners. Why would they outsource the protection of their people’s health? Dependence on big-pharma has already put countless lives in danger with untold disease, disabilities and death following in the wake of their unhinged global criminality. It should be noted, that despite their rampant criminality, they are all still very much in business, a testament to the unwarranted power and influence their immense profits and the lobbying efforts they purchase has afforded them.
If vaccines are determined to be beneficial to a nation’s population, they should be developed by that nation and administered only by that nation. There should be no multinational pharmaceutical corporations, because no nation should leave their population’s health to the whims of foreign entities who have already demonstrated the well-being of their customers is the least of their concerns.
And while nations taking up this responsibility and pushing out foreign pharmaceutical corporations is a good start, one must still consider the case of South Africa, where a government sought to destroy entire communities within their borders under the guise of vaccination programs. Individual communities and individuals themselves would be wise to think twice before allowing anyone to inject something into their body.
If vaccinations are so important, then the information required to make them should be made open source and all invited to examine how and why they are made and how to make them in community laboratories located at local universities and hospitals. If that can’t be done, then they probably aren’t that important to begin with nor any more legitimate or necessary than the dangerous antidepressants GSK peddled to little children in America, and surely something society could do well without.
It used to be when a drug company settled illegal marketing charges that millions took its drugs under false pretenses, the news would be released on a Friday afternoon when no one would notice. That was then. Now almost all the drug companies have joined the Off label/Kickback club and the public doesn’t seem to notice or care.
On the surface, Johnson & Johnson’s $2.2 billion settlement this week for illegally marketing drugs to the elderly, children and the mentally disabled looks like a victory. J&J’s subsidiary, Janssen Pharmaceuticals, will plead guilty to illegally promoting the antipsychotic Risperdal for “controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities,” reports Reuters. The promotions included a brazen kickback scheme to Omnicare Inc, a pharmacy supplying nursing homes, exposed by a whistleblower.
At least 15,000 elderly people in nursing homes die a year from drugs like Risperdal said FDA drug reviewer David Graham in Congressional testimony a few years ago. Eli Lilly who makes the similar drug Zyprexa and AstraZeneca who makes Seroquel have also settled charges that they churned the elderly drug market at the price of Grandma and Grandpa’s lives.
But it is not a victory. J&J made $24.2 billion off Risperdal from 2003 to 2010 and shareholders won’t even notice this week’s nano loss. J&J milked Risperdal for all it was worth and the patent had already run out by the time it was charged with illegal schemes. Other drug giants charged with illegal marketing schemes–Abbott for Depakote, Pfizer for Bextra, Eli Lilly for Zyprexa, AstraZeneca for Seroquel, GlaxoSmithKline for Paxil and Merck for Vioxx–also got their money’s worth before the trivial nuisance of suit. Many, like Pfizer who illegally marketed its seizure drug Neurontin while under probation for illegal Lipitor activities–are brazen and shameless repeat offenders.
Many say the only justice that will get Big Pharma’s attention is frog marching the CEOs off to prison and/or cutting them off from their lucrative public trough of Medicare, Medicaid and military health programs.
Still, Big Pharma’s audacious business plan of asking forgiveness not permission is winding down. Not because Pharma, prescribers, consumers, regulators and health officials have seen the light but because there are no more big drugs to pimp. An estimated 100,000 workers will be losing their jobs at Pfizer, Sanofi, Roche, GlaxoSmithKline, AstraZeneca and Merck reported Yahoo finance last month.
Only two new drug campaigns seem to be brewing and they require a major suspension of reality on the part of doctors and patients. One tries to convince people with low back pain they actually suffer from ankylosing spondylitis an arthritis-like condition that causes chronic inflammation of the spine. If your spine is stiff when you wake up in the morning you can take an immune suppressor like Humira which puts you at risk of tuberculosis and lethal viral, fungal and bacterial infections while costing you $12,000 to $17,000 a year. Line forms to the left.
The other, even more brazen campaign, tries to convince people with insomnia, tiredness during the day, moodiness and relationship problems that they actually suffer from Non-24-Hour Sleep–Wake Disorder, a disorder that affects mostly blind people. You don’t have to be blind to have the disorder, says the new Pharma message even though there have been fewer than 100 cases of sighted people with non-24 reported in the scientific literature. It sounds like a stretch but so did convincing people with job, money and marriage problems they really had depression or bipolar disorder.
Still it is obvious the bloom has fallen off the Big Pharma rose and it is now paying the piper for the high-flying party with drug settlements like Johnson & Johnson’s this week. But that doesn’t mean shady marketing, hidden risks, kickbacks and outrageous prices are gone from the medical field. They have just moved to the Medical Device industry.
Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: firstname.lastname@example.org.
The vast majority of medical experts in the U.S. who help formulate disease and diagnostic guidelines are taking money from the pharmaceutical industry, according to a new study.
The research published in the journal PLoS Medicine found that 75% of panelists who propose changes in disease definitions and diagnostic criteria had been paid by drug companies either as consultants, advisers or speakers.
Among those serving as chairs of these panels, 12 out of 14 were financially connected to the drug industry.
“Companies with financial relationships with the greatest proportion of panel members were marketing or developing drugs for the same conditions about which those members were making critical judgements,” Ray Moynihan, of Bond University in Robina, Australia, and colleagues wrote.
Examples cited by the researchers included GlaxoSmithKline, which had paid 20 of the 24 members of a 2009 task force that developed new definitions regarding asthma. It just so happens that the company sells the billion-dollar Advair, used to help asthma patients.
Also, Biogen, maker of the multiple sclerosis drug interferon beta-1a (Avonex), had ties to 13 of the 18 participants on a 2010 MS panel that expanded the definition to simplify diagnosis, the study revealed.
To Learn More:
Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States (by Raymond N. Moynihan, Georga P. E. Cooke, Jenny A. Doust, Lisa Bero, Suzanne Hill and Paul P. Glasziou, PLoS Medicine)
Pharma Ties Common on Guideline Panels (by David Pittman, MedPage Today)
Experts Related to Drug Makers Promote Narcotics for Seniors in Pain (by Noel Brinkerhoff, AllGov)
Doctors who Earn Hundreds of Thousands of Dollars Speaking for Drug Companies (by David Wallechinsky, AllGov)
“Yes,” According to Big Pharma Funded Doctors
How has Big Pharma managed to get so many children on expensive drug cocktails for “mental illness”? Drugs that they may not even need?
Big Pharma has spent millions on public relations campaigns that tell parents, teachers and clinicians to dose children at the first sign of problems. It knows if parents treat their kids early they will never know if the kids needed the drugs in the first place and whether residual problems are “mental illness” or drug side effects. The kids will also probably be life long customers because parents will be afraid to take them off the drugs. No wonder Pharma tells parents not to wait for “excessive energy” or “mood swings” to go away in the awareness campaigns. Ka-ching.
One “prescribe early” campaign for the atypical antipsychotic Risperdal uses a macabre abandoned wallet, a teddy bear, and keys on a barren street “to reposition a drug that was being used too late to achieve its maximum beneﬁts,” said its advertising agency, Torre Lazur McCann. Brand managers for Seroquel, a competing antipsychotic, even considered creating Winnie-the-Pooh characters like Tigger (bipolar) and Eeyore (depressed) to sell Seroquel, according to published reports, at an AstraZeneca sales meeting. Parents say they have seen toys emblazoned with Seroquel logos.
Only one child in ten thousand has pediatric schizophrenia—some say one in thirty thousand—but that doesn’t stop Gabriele Masi, MD, with the Stella Maris Institute for Child and Adolescent Neuropsychiatry at the University of Pisa in Italy from portraying it as a public health problem. In an article titled “Children with Schizophrenia: Clinical Picture and Pharmacological Treatment,” in the journal CNS Drugs, Masi writes, “Awareness of childhood- onset schizophrenia is rapidly increasing, with a more precise deﬁnition now available of the clinical picture and early signs, the outcome and the treatment strategies.”
Symptoms of childhood schizophrenia include “social deﬁcits” and “delusions . . . related to childhood themes,” writes Masi. What child doesn’t have “social deﬁcits”? Do delusions include imaginary playmates? Masi lambastes the “hesitancy on the part of clinicians to make a diagnosis of schizophrenia,” instead of prescribing early. Masi has received research funding from Eli Lilly, served as an advisor for Shire and been on speakers bureaus for Sanoﬁ Aventis, AstraZeneca, GSK, and Janssen, all of which manufacture many of the leading psychiatric drugs for children, according to the American Academy of Child & Adolescent Psychiatry.
It’s tempting to ridicule Pharma funded doctors who find mental illness and even relapses and “treatment resistance” in people who have been on the planet for forty months. But pathologizing three-year-olds isn’t funny. Both four-year-old Rebecca Riley of Hull, Massachusetts, and three-year- old Destiny Hager of Council Grove, Kansas, died in 2006 from psychiatric drugs that included Geodon and Seroquel to treat their “bipolar disorders.” And in 2009, seven-year-old Gabriel Myers of Broward County, Florida, a child in a state facility, hung himself while on Symbyax, a pill that combines Zyprexa and Prozac. If it weren’t for Big Pharma’s prescribe early campaigns, these children, and others, might still be alive.
Martha Rosenberg’s is an investigative health reporter. She is the author of Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).
It is no consolation to the roughly one out of 600 families who lost their homes in the U.S. but Wall Street made a lot of money slicing and dicing mortgages it knew would implode, while hiding risks. Financial giants, like AIG, are still buzzing along and neither penalties or new laws will prevent a future crash, say financial analysts, because the risky business models have not really changed.
A similar Big Pharma bubble, leavened with risky blockbuster drugs that also blew up, is now bursting. Like Wall Street’s bundled high risk loans, the “tide” created by Big Pharma’s high risk drugs raised many ships during the 2000s from advertising, public relations and medical communication agencies to TV and radio stations, medical journals and doctor/pitchmen who shoveled in its marketing budgets. But now the joy ride is over and Pharma is shedding jobs and settling billions in claims without changing its risky business model, like Wall Street.
In Europe, governments are no longer willing to pay the high prices for drugs that they once did say published reports and some countries are drafting laws making drug makers “prove their drugs are effective or risk having them dropped from the coverage list, or covered at a lower rate.” Imagine!
Germany has already saved 1.9 billion euros in 2011 by refusing to pay higher prices for drugs unless they are clearly superior to existing medicines, and Pharma worries that other countries will also get tough and want scientific proof for drug effectiveness instead of marketing and spin. In the U.S. and elsewhere, a drug only needs to be superior to no drug (placebo) to be approved by regulators — yet “new” is conveyed as “better than any drug to date” in advertising. Some clinicians say Haldol, an inexpensive antipsychotic, and lithium, a similar affordable bipolar drug are better than blockbuster antipyschotics and bipolar drugs that created Pharma’s 2000 bubble.
Before the Vioxx scandal and major settlements over blockbuster drugs like Zyprexa, Bextra, Celebrex, Geodon and Seroquel, being a Pharma rep was probably the next best thing to working on Wall Street. Direct-to-consumer advertising did your pre-sell for you, and all you had to do was show up with your snappy Vytorin tote bag and samples case. Some Pharma reps had their own reception room with ice water, swivel chairs, and laptop ports at medical offices, and most waltzed in to see the doctor right in front of waiting and sick patients. (It didn’t hurt that reps were usually “hotties,” both men or women).
But, by 2011, the bloom had fallen off Pharma reps’ roses. The number of prescribers willing to see most reps fell almost 20 percent, the number refusing to see all reps increased by half, and eight million sales calls were “nearly impossible to complete,” reported ZS Associates. Blockbuster drugs that were found to be unsafe after their big sales push or even withdrawn altogether, did not help the reps’ credibility with doctors. After the aggressively marketed hormone therapy was linked to high incidences of cancer, stroke and heart attack, Wyeth (now Pfizer) announced it was eliminating 1,200 jobs and closing its Rouses Point, New York plant where Prempro products were manufactured.
As government and private insurers increasingly say, “You want us to cover what?” about expensive, dangerous drugs that are not even proven effective, Pharma bubble jobs are evaporating. Almost 20,000 jobs have vanished at AstraZeneca, Novartis and Pfizer in the last 12 months alone. (AstraZeneca scrapped 21,600 more since 2007). Meanwhile, Pharma is outsourcing more of its operations to poor countries.
Workers and people willing to be trial subjects are both a bargain in poor countries where many can’t understand drug risks or refuse them if they did (and most can’t afford the very drugs they help sell). In January the Argentinian Federation of Health Professionals accused drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis, reported CNN. In 2010, 10 deaths occurred during Pfizer and AstraZeneca drug trials at the Bhopal Memorial Hospital and Research Centre which was ironically built for survivors of the 1984 Bhopal gas disaster, reports MSNBC. 3,878 workers perished in Bhopal when chemicals leaked at a Union Carbide pesticide plant.
Outsourcing drug manufacturing to cheap venues also contributes to Pharma’s cascade of “quality control” problems in which drugs are mislabeled, contaminated or otherwise made dangerous. It is speculated that Johnson & Johnson’s CEO William Weldon “was pushed to retire because of all of the quality issues at McNeil as well as with the company’s hip implant products, which have resulted in a raft of litigation,” reports FiercePharma.
Like the Wall Street bubble, the Pharma bubble was built on products that industry, but not the public, knew were risky, sold for quick profits. Now regulators are examining some of these “assets” more closely and with disturbing findings. The FDA now warns that bestselling statin drugs like Lipitor and Crestor, even approved for children, are linked to memory loss and diabetes associated with. The equally well selling proton pump inhibitors like Nexium and Prilosec for acid reflux disease (GERD) are now believed to increase the risk of bone fractures by 30 percent.
In March, the FDA even rejected a Merck drug that combines the active drug in Lipitor with the active drug in Zetia and Vytorin, a drug that Forbes calls Son of Vytorin. Vytorin (the father) was advertised to treat both food and family “sources of cholesterol” until results from a study that Merck and Schering-Plough appeared to withhold from regulators showed the drug had no effect on the buildup of plaque in the arteries (believed to correlate with heart attack and stroke). There was such a gap between marketing and science, Sen. Chuck Grassley (R-Iowa) asked the General Accounting Office to investigate why the FDA was approving “drugs that appear to have little to no effect in protecting lives and increasing health.”
Yet even as clouds develop over Pharma’s top-selling drugs, some say the FDA is too hard on new drugs, not too easy. “The FDA is impeding useful innovations in the U.S.,” says former FDA deputy commissioner Scott Gottlieb in the a Wall Street Journal oped and lagging behind other countries. Former FDA commissioner Andrew Von Eschenbach, also writing in the WSJ, agrees. The FDA should improve U.S. drug competitiveness by allowing drugs “to be approved based on safety, with efficacy to be proven in later trials,” while the public is already taking the drugs. Isn’t that what’s happening now?
Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, will be published in April 2012 by Amherst, New York-based Prometheus Books. She can be reached at: email@example.com.
- The drugs don’t work for AstraZeneca (independent.co.uk)
- AstraZeneca to axe 7,000 jobs as revenues slump (independent.co.uk)
- AstraZeneca appoints new chairman for troubled times (independent.co.uk)
- Shorting Candidate AstraZeneca – Seekingalpha.com (seekingalpha.com)