The pharmaceutical industry is one of the most lucrative sectors in the world, generating $1.36 trillion a year and employing millions around the globe. The drug market has been estimated to reach as high as $4 trillion by 2030, with this rapid growth not just impacting demand for drugs but also driving changes to how these medications are made and distributed globally.
The “big pharma corruption” is a term that refers to the unethical and unfair practices of some pharmaceutical companies. These companies are often accused of using bribery, kickbacks, and other illegal tactics in order to increase their profits.
James Young, a ClassAction.com attorney who is widely recognized in the fields of pharmaceutical litigation, health fraud, and consumer protection, wrote this article. Mr. Young, together with John Yanchunis, is now preparing to file cases on behalf of many West Virginia counties, as well as the state of Kentucky, against opioid distributors, physicians, and state Boards of Pharmacy.
In a live video for ClassAction.com’s Facebook page, James Young delivered a variation of the following.
Pharmaceutical corporations approach new medication development with a single goal in mind: to make $1 billion.
Big Pharma’s race to develop the next blockbuster medication is a highly sophisticated campaign that employs a variety of tried-and-true strategies, some of which are legal and others which are not.
Big Pharma’s business motive often takes precedence over human safety.
Given the meticulous attention to detail that goes into producing and marketing drugs, it’s difficult to trust manufacturers when they claim ignorance when a drug causes substantial, previously unanticipated adverse effects. And, as several drug lawsuits have shown, hiding adverse safety data is frequently part of Big Pharma’s marketing strategy.
The eleven phases mentioned below are frequently followed by a chemical from first approval to blockbuster medicine.
1. Extend the usage of an existing medicine or patent-protected treatment. Alternatively, start an illness.
Drug formulations are an example of intellectual property held by pharmaceutical corporations. However, they can’t profit from a formulation until the FDA approves it to treat certain illness symptoms. As a result, the first step is to contact the FDA and request approval to use a medicine for a specific therapy. A new drug’s research and approvals typically take four to six years to complete.
If there are no illness criteria that match the symptoms treated by a business’s medicine, the company constructs one.
If there are no illness criteria that match the symptoms that a business’s medicine addresses, the corporation will simply manufacture one. They pay for doctors, research institutes, and colleges to develop illness criteria that are compatible with the symptoms that the medicine addresses. Simultaneously, they’re fostering grassroots support for new drug alternatives via patient support groups that they’ve either founded or supported.
2. Hide data in order to get more approvals.
In addition to clinical trials, pharma corporations perform their own experiments, known as “surveillance,” to monitor how these treatments are being used in the general population. Drug monitoring generates very reliable data sets that indicate to drug producers the negative side effects of their products. In the medicine’s label, manufacturers are obligated to notify the public about the hazardous side effects of the drug.
However, this isn’t always the case. When they don’t, the pharmaceutical corporation is subjected to product responsibility lawsuits.
Companies may get larger authorization or indications for the use of their products by withholding facts, especially safety data. A medicine can’t earn a billion dollars if it can’t be sold to a large number of people.
For example, Purdue Pharma’s OxyContin was first licensed to treat end-stage cancer pain, sometimes known as “breakthrough” agony. Purdue persuaded the FDA to approve off on using OxyContin for chronic pain, which is fundamentally different from breakthrough pain and has a considerably wider patient pool, since the market for breakthrough pain was too tiny to become a billion-dollar medicine.
3. Create a fake front or support group to broaden the market.
Let’s imagine you’re an American pharmaceutical business looking for a patient advocacy organization to help you get your medicine approved and used. If an advocacy organization won’t do it, or if one doesn’t exist for the ailment or symptoms your medicine addresses, you can create one yourself. You finance the organization from a variety of opaque sources and build grassroots support, such as individuals requesting more pain meds for Iraqi soldiers returning home.
Many of the support groups and patient advocacy organizations are, in fact, financed by Big Pharma. Many of them are not genuine.
4. If everything else fails, pay kickbacks.
Drug corporations utilize a variety of workarounds since paying a physician a bribe for issuing a prescription is illegal in the United States.
These activities bring in a lot of money for doctors.
“We would greatly want you and your team of doctors at your clinic or hospital to utilize our medication,” a pharma firm would say to a doctor. We’ll enable you to perform a clinical study at your institution in exchange. And we’ll compensate you for it on a per-patient basis. We’ll also provide you free goods to use in the offices, so your patients won’t have to spend anything out of pocket.”
This is a kind of kickback. When done publicly and clearly, it is sometimes permissible, but it is not always.
Recruiting doctors to speak for your pharmaceutical firm at conferences and gatherings is another sort of kickback. Physicians are compensated for traveling to and speaking at opulent resorts such as Maui, South Beach, and Las Vegas. They also host their own “lunch and learns” and CME (continuing medical education) sessions.
These activities bring in a lot of money for doctors.
5. Use important opinion leaders to do stealth or guerilla marketing.
When a drug manufacturer gives a physician a kickback, the goal is to induce the physician’s patients to utilize the product. A medicine manufacturer may purchase significantly more influence by enlisting the help of “important opinion leaders.”
You develop a key opinion leader that everyone else will follow by using stealth and guerilla marketing to target key opinion leaders—to figure out who they are, track their movements through social media and sales representatives who call on them in the office, by paying them kickbacks and paying them to speak.
For example, “Dr. Smith” is New York City’s number one physician for a certain ailment. If a medication firm can persuade Dr. Smith to use and suggest their product, then other physicians who listen to him will do the same.
Big Pharma locates a significant opinion leader not only in one location, but in every city in the country.
6. Make collusive arrangements with pharmaceutical benefit managers (PBMs) or the competitors.
Pharmaceutical firms get into antitrust or collusive arrangements with insurers or PBMs (Pharmacy Benefit Management Companies, the insurance component of your pharmacy benefit) and pay rebates or bribes to them in order to cut their pricing and become the formulary’s first choice.
Pharmaceutical corporations rig the system by bribing competitors to keep their drugs off store shelves.
They’ll also make collusive deals with rivals. These are sometimes known as “co-marketing” or “co-branding” deals. Although Company A may be the first to market with a certain product, the competition is close behind. They may earn $100 million in the first year if they go public. Company A may pay the competitors to stop marketing their medicine and instead work with them to co-market it. They keep the $100 million, but their product never makes it to market.
Another form of this is when generic medications are used. When generic medications become available, there’s no requirement for the branded version of that drug to remain on a PBM’s formulary (assuming they’re similar). However, it often persists. You can bet that some kind of co-marketing or co-branding has gone place behind the scenes.
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7. Commit pricing deception.
Martin Shkreli is well-known for purchasing intellectual property or licensing to utilize certain pharmaceuticals, then jacking up the price by as much as 1,000% in some situations. We recently witnessed this with the EpiPen. Mylan, the EpiPen’s owner, not only raised the price, but also offered them in two-packs, making it impossible to acquire a single EpiPen. It was necessary for you to purchase two.
For example, if you require 5 mg for a therapeutic dose of a medicine but it’s only accessible in 7.5 mg quantities, you can’t divide it in half since that’s not five. Companies do, in fact, adjust the potency of these medications’ dosage to prevent patients from splitting doses.
8. Seek assistance from Congress.
Pharmaceutical businesses are skilled at exerting pressure on Congress, the FDA, and the DEA to grant them their wishes.
One way they accomplish this is by complaining to the FDA about how long it takes to approve medications. They gather a group of individuals suffering by this rare condition to petition Congress, marching outside the FDA offices and declaring, “We want our meds, and we want them now!”
The FDA, in truth, plays a critical role. Before giving authorization, they must assess the safety and effectiveness of each medicine. This need thorough clinical studies using real-world data to ensure that people taking the treatment do not die of heart attacks or other major adverse effects five years down the line.
Companies are effectively decreasing the time for approval and compromising the FDA’s authority to establish safety and effectiveness by pressing Congress to speed up the process.
9. Pay to postpone the arrival of generic competition.
“Pay to delay” is another sort of antitrust or collusive deal.
Consider a pharmaceutical business that sells a branded medicine named “The Acme Pill.” The Acme Pill’s patent protection will expire at the end of this year, and a generic counterpart will be available. Because of the price differential, no insurance company will pay or allow its insureds to take The Acme Pill after the drugmaker’s patent expires and the generic is licensed to enter the market.
When a generic version of a medicine is available, drug corporations deceive customers by compelling them to purchase the branded version.
Drugmakers engage into a “pay to delay” deal to prevent generics from hitting the market. To put it another way, they pay the generic firm to keep its generic version off the market.
Drug corporations that do this are defrauding the American public by compelling consumers to purchase branded prescriptions when generics are available.
To prolong the life of your patent, introduce new combinations or formulae.
By developing a new product known as a combination product, manufacturers may get renewed or extended patent protection and stave off generic competition.
A blood pressure medicine may include fish oil or aspirin, depending on the manufacturer. Those chemicals are blended in a single tablet, FDA clearance is expedited, and the medicine is protected by a brand-new patent, preventing generics from gaining market dominance.
Despite the fact that the generic is still available, marketing people go about enticing doctors to prescribe the new “better” combo medicine.
11. If your patent expires, just promote new medications while criticizing generics.
Rather of developing a new combination medicine, a pharmaceutical firm might switch to the second or third generation of the drug, also known as the atypical version.
The new medications might have potentially dangerous adverse effects, which could lead to product responsibility lawsuits.
This happened with antipsychotic drugs such as Risperdal. There were fantastic medications for treating bipolar illness and schizophrenia for many years. Pharmaceutical firms developed a number of novel substances, but they quickly found they couldn’t sell them since generics were so inexpensive.
As a result, they conducted rigorous studies—some of which were based on deception and some on fact—to promote the reintroduction of “atypical antipsychotics” including Zyprexa, Risperdal, Seroquel, and Geodon. The generic analogues, prior medications, or original antipsychotics were subsequently condemned by the sales representatives for those drug firms.
But The new medications might have potentially dangerous adverse effects, which could lead to product responsibility lawsuits. Those side effects are now listed on the label as a result of litigation.
12. Rinse and repeat the process.
After all of these processes are accomplished, pharma firms repeat the process with a whole new product, chemical, or condition, and send their marketing teams out to advertise it.
To go out and sell their products, these businesses recruit the finest and brightest individuals. They recruit beautiful individuals who know how to enter into doctors’ heads and influence their decisions.
Drug firms know that if they spend a certain amount of money, they can get a certain proportion of the market. It’s just an issue of business for them.
So, what are the options for the healthcare consumer?
What can you do with this knowledge as a healthcare consumer?
To begin, consult the Open Payments database, which is a federal government database that keeps account of all payments made by pharmaceutical firms to doctors. Discover who is paying your doctor to influence their prescription writing. Consider if the corporation that pays your doctor the most is also the manufacturer of the prescription that he just recommended to you.
Examine your doctor’s payment history, speak with them directly, pay attention, and always read medicine labels.
You may also speak with your physician or healthcare provider directly. “Have you been paid to endorse this product?” inquire. Do you work for this pharmaceutical firm as a key opinion leader? Have you taken this product to any resorts to advertise it? What is it about this branded medicine that you believe makes it more useful and therapeutic for me than the generic?” These are challenging things to ask, but if you don’t, you’ll never know what factors your doctor considers when making a choice.
In the workplace, you should also be vigilant. Detail elements, such as coffee mugs or pens, are left by pharmaceutical corporations. If you discover that the medicine your doctor is prescribing is also on his coffee cup and the pen he’s using to write the prescription, this indicates that sales agents were there, resulting in you receiving a drug you may not need.
Finally, always read the label on any medication you’re given. Almost no one reads the label, which includes all of the cautions that pharmaceutical firms are supposed to offer. You may check the warnings to determine whether the symptoms and condition you have are genuinely authorized and included on the label.
For example, if you have a migraine headache and your doctor recommends a medication, you should know whether or not that medication has been authorized by the Food and Drug Administration (FDA) to treat migraines. It might be a tranquilizer that isn’t licensed for migraine treatment. It might be a different sort of medicine for a different ailment or symptom, and this doctor is sure — and empirically backed — that it will benefit you in your situation.
It’s possible. However, you should be aware of this ahead of time.
Hold the Pharmaceutical Industry Accountable
Pharmaceutical corporations often prioritize profits above patients in their desire for market supremacy. You do, however, have the ability to fight back and hold corporations responsible.
Drug lawsuits may not only result in more stringent warning labels, but they can also serve as a reminder to pharmaceutical firms that their actions have ramifications.
ClassAction.com can assist you if you have been hurt by a medication or medical device. Our qualified and experienced lawyers have taken on and defeated some of the world’s largest pharmaceutical firms. For a free case evaluation, please contact us.
The “u.s. pharmaceutical industry profits 2019” is a blog that discusses the history of the pharmaceutical industry and how to make a billion dollars in the field.
Frequently Asked Questions
How profitable is the pharmaceutical industry?
A: The pharmaceutical industry is a lucrative and profitable market. With the number of people suffering from diseases that could be helped by medications exceeding the entire population, it is one of the most highly sought after industries in todays world.
Do pharmaceuticals make good money?
A: Yes, pharmaceuticals are very profitable. However they come with many risks and complications that make it not always the best choice for people to pursue as a career path.
Which pharmaceutical company makes the most money?
A: Roche Group.
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