Controversies
Drug marketing and lobbyingedit
There has been increasing controversy surrounding pharmaceutical marketing and influence. There have been accusations and findings of influence on doctors and other health professionals through drug reps including the constant provision of marketing 'gifts' and biased information to health professionals; highly prevalent advertising in journals and conferences; funding independent healthcare organizations and health promotion campaigns; lobbying physicians and politicians (more than any other industry in the US); sponsorship of medical schools or nurse training; sponsorship of continuing educational events, with influence on the curriculum; and hiring physicians as paid consultants on medical advisory boards.
Some advocacy groups, such as No Free Lunch and AllTrials, have criticized the effect of drug marketing to physicians because they say it biases physicians to prescribe the marketed drugs even when others might be cheaper or better for the patient.
There have been related accusations of disease mongering (over-medicalising) to expand the market for medications. An inaugural conference on that subject took place in Australia in 2006. In 2009, the Government-funded National Prescribing Service launched the "Finding Evidence – Recognising Hype" program, aimed at educating GPs on methods for independent drug analysis.
Meta-analyses have shown that psychiatric studies sponsored by pharmaceutical companies are several times more likely to report positive results, and if a drug company employee is involved the effect is even larger. Influence has also extended to the training of doctors and nurses in medical schools, which is being fought.
It has been argued that the design of the Diagnostic and Statistical Manual of Mental Disorders and the expansion of the criteria represents an increasing medicalization of human nature, or "disease mongering", driven by drug company influence on psychiatry. The potential for direct conflict of interest has been raised, partly because roughly half the authors who selected and defined the DSM-IV psychiatric disorders had or previously had financial relationships with the pharmaceutical industry.
In the US, starting in 2013, under the Physician Financial Transparency Reports (part of the Sunshine Act), the Centers for Medicare & Medicaid Services has to collect information from applicable manufacturers and group purchasing organizations in order to report information about their financial relationships with physicians and hospitals. Data are made public in the Centers for Medicare & Medicaid Services website. The expectation is that relationship between doctors and Pharmaceutical industry will become fully transparent.
In a report conducted by the Center for Responsive Politics, there were more than 1,100 lobbyists working in some capacity for the pharmaceutical business in 2017. In the first quarter of 2017, the health products and pharmaceutical industry spent $78 million on lobbying members of the United States Congress.
Medication pricingedit
It has been argued that the pricing of pharmaceuticals is becoming a major challenge for health systems.
Regulatory issuesedit
Ben Goldacre has argued that regulators – such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, or the Food and Drug Administration (FDA) in the United States – advance the interests of the drug companies rather than the interests of the public due to revolving door exchange of employees between the regulator and the companies and friendships develop between regulator and company employees. He argues that regulators do not require that new drugs offer an improvement over what is already available, or even that they be particularly effective.
Others have argued that excessive regulation suppresses therapeutic innovation and that the current cost of regulator-required clinical trials prevents the full exploitation of new genetic and biological knowledge for the treatment of human disease. A 2012 report by the President's Council of Advisors on Science and Technology made several key recommendations to reduce regulatory burdens to new drug development, including 1) expanding the FDA's use of accelerated approval processes, 2) creating an expedited approval pathway for drugs intended for use in narrowly defined populations, and 3) undertaking pilot projects designed to evaluate the feasibility of a new, adaptive drug approval process.
Pharmaceutical fraudedit
 | The examples and perspective in this section deal primarily with the United States and do not represent a worldwide view of the subject. (August 2015) (Learn how and when to remove this template message) |
Pharmaceutical fraud involves deceptions which bring financial gain to a pharmaceutical company. It affects individuals and public and private insurers. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Of this amount $2.5 billion was recovered through False Claims Act cases in FY 2010. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement and Merck & Co. $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).
Every major company selling the antipsychotics—Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca and Johnson & Johnson—has either settled recent government cases, under the False Claims Act, for hundreds of millions of dollars or is currently under investigation for possible health care fraud. Following charges of illegal marketing, two of the settlements set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly's antipsychotic Zyprexa, and the other involved Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.
On 2 July 2012, GlaxoSmithKline pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud case in the U.S. and the largest payment by a drug company. The settlement is related to the company's illegal promotion of prescription drugs, its failure to report safety data, bribing doctors, and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses. Those and the drugs Imitrex, Lotronex, Flovent, and Valtrex were involved in the kickback scheme.
The following is a list of the four largest settlements reached with pharmaceutical companies from 1991 to 2012, rank ordered by the size of the total settlement. Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud, off-label promotion, and inadequate manufacturing practices.
| Company | Settlement | Violation(s) | Year | Product(s) | Laws allegedly violated (if applicable) |
|---|---|---|---|---|---|
| GlaxoSmithKline | $3 billion | Off-label promotion/ failure to disclose safety data |
2012 | Avandia/Wellbutrin/Paxil | False Claims Act/FDCA |
| Pfizer | $2.3 billion | Off-label promotion/kickbacks | 2009 | Bextra/Geodon/ Zyvox/Lyrica |
False Claims Act/FDCA |
| Abbott Laboratories | $1.5 billion | Off-label promotion | 2012 | Depakote | False Claims Act/FDCA |
| Eli Lilly | $1.4 billion | Off-label promotion | 2009 | Zyprexa | False Claims Act/FDCA |
Clinical trialsedit
Due to repeated accusations and findings that some clinical trials conducted or funded by pharmaceutical companies may report only positive results for the preferred medication, the industry has been looked at much more closely by independent groups and government agencies.
In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research was not published, the Pharmaceutical Research and Manufacturers of America have published new guidelines urging companies to report all findings and limit the financial involvement in drug companies of researchers. US congress signed into law a bill which requires phase II and phase III clinical trials to be registered by the sponsor on the clinicaltrials.gov website run by the NIH.
Drug researchers not directly employed by pharmaceutical companies often look to companies for grants, and companies often look to researchers for studies that will make their products look favorable. Sponsored researchers are rewarded by drug companies, for example with support for their conference/symposium costs. Lecture scripts and even journal articles presented by academic researchers may actually be "ghost-written" by pharmaceutical companies.
An investigation by ProPublica found that at least 21 doctors have been paid more than $500,000 for speeches and consulting by drugs manufacturers since 2009, with half of the top earners working in psychiatry, and about $2 billion in total paid to doctors for such services. AstraZeneca, Johnson & Johnson and Eli Lilly have paid billions of dollars in federal settlements over allegations that they paid doctors to promote drugs for unapproved uses. Some prominent medical schools have since tightened rules on faculty acceptance of such payments by drug companies.
In contrast to this viewpoint, an article and associated editorial in the New England Journal of Medicine in May 2015 emphasized the importance of pharmaceutical industry-physician interactions for the development of novel treatments, and argued that moral outrage over industry malfeasance had unjustifiably led many to overemphasize the problems created by financial conflicts of interest. The article noted that major healthcare organizations such as National Center for Advancing Translational Sciences of the National Institutes of Health, the President's Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration had encouraged greater interactions between physicians and industry in order to bring greater benefits to patients.
Response to COVID-19edit
Doctors Without Borders warned that high prices and monopolies on medicines, tests, and vaccines would prolong the pandemic and cost lives. They urged governments to prevent profiteering, using compulsory licenses as needed, as had already been done by Canada, Chile, Ecuador, Germany, and Israel.
On 20 February, 46 US lawmakers called for the US government not to grant monopoly rights when giving out taxpayer development money for any coronavirus vaccines and treatments, to avoid giving exclusive control of prices and availability to private manufacturers.
On 26 February 2020, the US Health and Human Services Secretary (former pharmaceutical CEO Alex Azar testified before the House Energy and Commerce Committee. At this meeting Azar repeatedly refused to say that any coronavirus vaccine or treatment would be made accessible to all Americans, not only to those wealthy enough to pay. Representatives questioning him criticized his position. Hours later, President Trump, who was said be skeptical of the secretary's ability to handle the job, abruptly transferred responsibility for the pandemic to vice-president Mike Pence. Some attached importance to the fact that the president then walked out on Azar's explanation to the press that he was remaining as Health and Human Services Secretary; it was reported that Trump had not dismissed him during a crisis for the sake of appearances.
On 2 March, US Representative Jan Schakowsky wrote to Alex Azar, saying "You must understand that the House of Representatives would find it unacceptable if taxpayer dollars were used to develop a vaccine for COVID-19 and the rights to produce and market that vaccine were subsequently handed over to a pharmaceutical manufacturer through an exclusive license with no conditions on pricing or access, allowing the company to charge whatever it would like and essentially selling the vaccine back to the public who paid for its development."
The 6 March Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 originally allowed the US government to bring in compulsory licensing where prices are excessive; after lobbying, this was removed, and a provision was added to prevent the US government from taking any action on affordability if it might delay coronavirus vaccine or treatment availability. Observers disagreed as to whether the bill would help or hinder affordability.
Regeneron Pharmaceuticals made a deal with the US-government Biomedical Advanced Research and Development Authority that the government would fund 80% of the costs for Regeneron to develop and manufacture coronavirus treatments, and Regeneron would retain the right to set prices and control production. This deal was criticized in the New York Times. Such deals are not unusual for routine drug development in the American pharmaceutical market.
American pharmaceutical company Gilead sought and obtained orphan drug status for remdesivir from the US Food and Drug Administration (FDA) on 23 March 2020. This provision is intended to encourage the development of drugs affecting fewer than 200,000 Americans by granting strengthened and extended legal monopoly rights to the manufacturer, along with waivers on taxes and government fees. Remdesivir is a candidate for treating COVID-19; at the time the status was granted, fewer than 200,000 Americans had COVID-19, but numbers were climbing rapidly as the COVID-19 pandemic reached the US, and crossing the threshold soon was considered inevitable. Remdesivir was developed by Gilead with over $79 million in U.S. government funding. In May 2020, Gilead announced that it would provide the first 940,000 doses of remdesivir to the federal government free of charge. After facing strong public reactions, Gilead gave up the "orphan drug" status for remdesivir on 25 March. Gilead retains 20-year remdesivir patents in more than 70 countries. In May 2020, the company further announced that it was in discussions with several generics companies to provide rights to produce remdesivir for developing countries, and with the Medicines Patent Pool to provide broader generic access.
US diagnostic test maker Cepheid Inc received a US FDA Emergency Use Authorization for a COVID-19 test called Xpert Xpress SARS-CoV-2. The test uses the same machines which are commonly used to test for tuberculosis and HIV, among other diseases, and gives results in 45 minutes, faster than some other tests. Cepheid announced that they would charge US$19.80 per test in developing countries. Doctors without borders stated that that price was not affordable in countries where people live on less than two dollars a day. They estimated that the cost to Cepheid of providing the test is as low as $3, and called the offered price profiteering, asking that Cepheid make a more moderate profit by selling the tests for US$5 each. The Treatment Action Group (TAG) seconded this request, saying that the development of the tests, and their purchase and global deployment, has been done with public funds, while the owners of Cepeid made profits of $3 billion in 2019. TAG also started the "Time for $5" campaign. Analogous tests for hepatitis C virus (another RNA virus) cost from 50 US cents (for five-minute antibody tests) to US$5 (for more complex genome tests similar to Cepheid's). Widespread testing with these cheap tests has been critical to eliminating hepatitis C in Egypt, and similar mass-testing techniques have regionally been successfully used against COVID-19.
Comments
Post a Comment