The NY Times had an article explaining how dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a ridiculous Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs.   The Supreme Court’s ruling, which was split 5 to 4 on ideological lines, has its roots in the Hatch-Waxman Act, the 1984 law that led to generic drugs. That law allowed companies to skip the approval process required if they could prove that the generic drug was equivalent to its brand-name counterpart.  It also required generic manufacturers to use the same labels — the lengthy list of a drug’s uses, dosages and risks — used by the brand names.

If a problem develops, the brand-name companies are responsible for changing the label, and the generic companies must follow their lead. As a result, the court’s majority ruled, generic companies cannot be held responsible for failing to alert patients to problems with their drug. The dissent, which was written by Justice Sonia Sotomayor, argued that generic companies nevertheless have a responsibility to report problems to the F.D.A. and should be held liable for failing to warn patients.

The article refers to two cases:
Debbie Schork, a deli worker at a supermarket in Indiana, had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it.  Her case was quietly thrown out of court.  That result stands in contrast to the case of Diana Levine, a professional musician from Vermont. Her hand and forearm were amputated because of gangrene after a physician assistant at a health clinic injected her with the same drug. She sued the drug maker, Wyeth, and won $6.8 million.

The financial outcomes were radically different for one reason: Ms. Schork had received the generic version of the drug, known as promethazine, while Ms. Levine had been given the brand name, Phenergan.   How is that fair or just?

Almost 80 percent of prescriptions in the United States are filled by a generic, and most states allow pharmacists to dispense a generic in place of a brand name. More than 40 judges have dismissed cases against generic manufacturers since the Supreme Court ruled last June, including some who dismissed dozens of cases consolidated under one judge.

Mr. Waxman argued in a brief opposing the generic companies in the Supreme Court case last year that Congress had never intended for generic companies to be freed of all responsibility. “Congress did not intend for consumers’ rights to be categorically eliminated simply because they purchased a generic rather than a brand-name drug,” he wrote.

Recently, the White House laid out new steps to cut fraud in Medicare and Medicaid.  Many of the moves that support Obama’s “we can’t wait” mantra are modest  including the newest measures being pilot programs intended to further cut waste and fraud in the Medicare and Medicaid entitlement programs. The Health and Human Services Department will oversee the changes, such as testing changes to outdated hospital billing systems to prevent overbilling.

To show that its broad campaign to cut government waste is working, the White House says the administration cut improper payments by nearly $18 billion in 2011.  The NY Times Economix blog had an article with a simple way to save more Medicare money without hurting patients. Don’t pay for treatments found to be useless.

The article mentions that The Food and Drug Administration revoked the approval of the drug Avastin as a treatment for breast cancer because “the drug was not helping breast cancer patients to live longer or control their tumors, but did expose them to potentially serious side effects such as severe high blood pressure and hemorrhaging.”

However, the drug remains on the market for other uses, meaning doctors can prescribe it if they wish to do so and Medicare will continue to pay the unnecessary bills.

 The article explains:

Medicare is obligated to pay for off-label use of cancer drugs that are listed in references known as compendia, such as the one published by the National Comprehensive Cancer Network, an organization of major cancer hospitals.

In July, shortly after the F.D.A. advisory committee voted to revoke the approval, a committee of breast cancer specialists assembled by the cancer network reaffirmed that Avastin should remain listed as “an appropriate therapeutic option for metastatic breast cancer.”

So a committee that includes doctors who may stand to profit from getting the government to pay for useless medicines — or even have ties to the drug maker — can get to overrule the F.D.A. on how to spend scarce taxpayer money.

Bloomberg BusinessWeek and Chicago Tribune reported the settlement between the U.S. government and Abbott Laboratories who agreed to pay at least $1.3 billion for illegally marketing its Depakote epilepsy drug

Abbott executives, federal prosecutors and state officials reached a tentative agreement calling for the drugmaker to pay about $800 million to resolve civil claims over Depakote and about $500 million in criminal penalties for marketing the epilepsy medicine for unapproved uses.   Abbott said earlier this week it was reserving $1.5 billion to cover costs of the potential settlement.

The settlement would be the third-largest illegal pharmaceutical marketing accord in U.S. history, behind the $2.3 billion Pfizer paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. paid the same year over sales of its Zyprexa anti-psychotic medicine.

The whistle-blowers claim the drugmaker marketed Depakote for unapproved uses including agitation and aggression in patients with dementia, autism, sexual compulsion and other disorders.  Abbott began marketing to elderly patients with Alzheimer’s and dementia in about 1998. Abbott knew that Depakote “was unapproved for the treatment of Alzheimer’s, did not work to treat the disease and was actually dangerous for use by the elderly,”.

Federal regulators only approved Depakote for the prevention of migraines, treating acute manic episodes in bipolar patients and halting seizures in adults and children.  Drug companies aren’t allowed to promote a drug for uses other than those approved.  Sales of Depakote “rocketed to over $1.4 billion per year” as a result of improper marketing,  “Compensation for senior executives soared as well.”

The Depakote case is U.S. ex rel. McCoyd v. Abbott Laboratories, 1:07-cv-00081, U.S. District Court, Western District of Virginia (Abingdon).
 

The Office of the Inspector General released a detailed report showing more than half of Medicare claims for atypical antipsychotic drugs are erroneous, amounting to at least $116 million of waste.  The report evaluated the extent to which atypical antipsychotic drugs were provided to nursing home residents aged 65 and older who were diagnosed with conditions that were off-label and/or specified in the FDA boxed warning and whether Medicare erroneously paid for these drugs.

Based on a medical record review conducted by board-certified psychiatrists knowledgeable in the prescribing of atypical antipsychotic drugs for the elderly, OIG found that:

14% of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs;
83% of Medicare claims for such drugs for elderly nursing home residents were associated with off-label conditions and 88% were
associated with dementia, a condition specified in an FDA boxed warning;
51% of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were erroneous, amounting to $116 million; and
22% of the atypical antipsychotic drugs claimed were not administered in accordance with CMS standards regarding unnecessary drug use in nursing homes, amounting to $63 million.

To ensure that Medicare correctly pays for atypical antipsychotic drugs and that elderly nursing home residents are free from unnecessary drugs, OIG recommended that CMS:

–Facilitate access to information necessary to ensure accurate coverage and reimbursement determinations.
–Assess whether survey and certification processes offer adequate safeguards against unnecessary antipsychotic drug use in nursing homes.
–Explore alternative methods beyond survey and certification processes to promote compliance with Federal standards regarding unnecessary drug use in nursing homes.
–Take appropriate action regarding the claims associated with erroneous payments identified in our sample.
 

Daniel Levinson is the inspector general for the OIG in the Department of Health and Human Services and he wrote an opinion piece for CNN.   Excerpts are below:

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.

Frequently, they are prescribed in ways that don’t qualify as medically accepted for Medicare coverage. In addition, the drugs were predominately prescribed for uses that are not approved by the Food and Drug Administration.

But the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia. Many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for years.

This is precisely the population that faces an increased risk of death when using this class of drugs, according to the FDA. That’s why the agency puts its strongest safety warning, called a "black box warning" on these antipsychotic drugs, cautioning about the risk of death when taken by elderly people with dementia.

Pharmaceutical companies have paid billions to resolve civil and criminal liabilities under federal health and safety laws. But money can’t adequately compensate for corporate campaigns that could put vulnerable, elderly patients at risk.

Government must combat illegal off-label promotion of these powerful and potentially lethal drugs and uphold nursing home safety standards.

See articles at Gant Daily, CBS News, and Modern Medicine.

 

Masters in HealthCare ran an article called 15 Disturbing Facts About the FDA.  Americans count on the U.S. Food and Drug Administration (FDA) to regulate food and pharmaceutical items so that only the safest, most effective products hit the market. That’s definitely not the case, as these disturbing facts show.

1.  They keep important drug information off the label: Two drug safety experts called out the FDA in the fall of 2009 for leaving off important drug information when listing ingredients on labels. Even doctors were left in the dark about certain drug information, and in the case of the osteoporosis drug, Zometa, a slightly higher dose could increase the risk of death in cancer patients.

2.  Their tomato mistake ruined the industry: During one of the many salmonella outbreaks in the last few years, the FDA pointed to tomatoes as being the carrying culprit. People all over the country stopped eating tomatoes, a major ingredient in all types of foods made at home and in restaurants. The slow-down of the industry was a huge hit to farmers, and Florida lost most of its harvest because of the FDA’s cautioning. Turns out tomatoes had nothing to do with the outbreak whatsoever.

3.  Budget cuts might be coming: Earlier this year, Congress looked ready to cut funding to the FDA as with many other government agencies. The FDA is worried about handling the fallout from Japanese radiation, however, possibly swaying President Obama to override the cuts and in fact give more money to the FDA for 2012.

4.  The FDA approved canola oil: There’s a bit of debate among health experts and natural foodies about the safety of canola oil, which is no longer extracted from the somewhat toxic plant, rapeseed. Mayo Clinic blogger Katherine Zeratsky, R.D., L.D., points out that "canola oil is generally recognized as safe by the Food and Drug Administration," which isn’t a very strong stance one way or the other, and it has actually been banned in Europe.

5.  They failed to comment on a test subject’s suicide: A 19-year-old college student who was working as a test subject for the FDA as it researched a new antidepressant hanged herself in the lab of an Indianapolis-area drug company. Because the drug manufacturer hadn’t publicized any negative side effects about their product, the FDA was expected to share its findings and continue with research to attempt to find a reason for the suicide. They didn’t. Instead, the FDA said that if they released information about how the suicide and drug’s side effects were related, they would be releasing trade secrets, possibly compromising the drug company’s recipe and overall business.

6.  The FDA tends to "sit on" questionable data: In a 2009 New York Times article, it was revealed that the FDA has a nasty habit — it "often sits on data that raise questions about a drug’s safety or therapeutic value." In other words, FDA agents keep quiet when they learn about adverse side effects, including shocking symptoms like increased heart attack risks in one painkiller and an increase in children’s suicidal thoughts and behaviors in antidepressants. Their obsession with keeping trade secrets safe inspired a call for more transparency in the process of drug approval.

7.  They were partly behind the Vioxx deaths: Along with drug company Merck, the FDA was blamed for promoting and refusing to recall the drug Vioxx, which "caused an untold number of fatalities among the American population," according to NaturalNews.com. Apparently, the FDA was pressed to run additional clinical trials after Vioxx caused heart attacks, but the FDA approved the drug anyway, without extra research or recalls.

8.  Just because a drug is approved, doesn’t mean the FDA believes it works well: The main rule of thumb for drug approval is that if its benefits outweigh its side effects, it gets the go-ahead to hit the market. But while many Americans think that FDA-approved medicine means the drug is high quality, it may not be.

9.  FDA leaders have chosen to side with drug companies, and ignore science: Two years ago, a group of FDA scientists wrote a letter to President Obama asking for wholesale change of the organization, as they believed leaders were corrupt and consistently ignoring their research, and instead choosing to promote drug companies. At first, some believed the letter was a fake, but when it was validated, a closer look of the letter revealed that the scientists also accused the FDA of actually breaking their own laws, "altering scientific findings," removing Black Box warnings, made false statements in FDA documents, and the approval of a mammogram device after FDA experts voted unanimously against it.

10.  They re-approved a drug that killed 80,000 people: Many health and patient advocates felt that the diabetes drug Avandia should be taken off the market after it was suspected of killing around 80,000 people, but after a special meeting was called, the FDA disagreed. Although the FDA proved through a vote that they believed the drug was dangerous, they decided stronger warning labels would be a sufficient solution.

11.  Most Americans don’t approve of the FDA’s alleged neutrality: Four out of five Americans believe that the FDA is too heavily influenced by drug companies, and 96% of Americans want the government to put warning labels on drugs with known safety concerns.

12.  It’s all relative: In a report by NaturalNews.com, the FDA’s twisted logic for drug approval was unwound. Their decisions are based on relative comparisons — not on drug safety but on drug deadliness. If a drug is no more deadly than any other comparable drug on the market, it can be approved.

13.  Stock scandal: A FDA chemist was charged with insider trading, stockpiling — along with his son — $3.6 million. He used inside information about drug approvals to make calculated trades.

14.  "Extraordinarily complex" data is an excuse for making the wrong decisions: When called out on the Avandia scandal, FDA officers blamed the drug company Glaxo for throwing "extraordinarily complex" data at them, apparently thinking that was a valid excuse for making a bad decision endangering tens of thousands of lives.

15.  They were reluctant to pursue criminal prosecutions: Last spring, the FDA began stepping up its criminal prosecutions of offending drug and food company executives after it was pressured by Congress to do so. Critics of the FDA had noticed that the agency was being too lax with its investigations and had "fallen short" in terms of developing performance standards in its criminal unit.
 

Lauren Stevens of Durham, N.C., an attorney for a major pharmaceutical company was charged with obstruction and making false statements  She was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).

The indictment states that in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved – or "off-label" – uses.

The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials. The indictment alleges that a memorandum was prepared for Stevens that set forth the "pros" and "cons" of producing the slide sets to the FDA. One of the "cons" was that the slide sets would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation." Instead of providing the requested slide sets to the government, Stevens represented that the company’s responses to the FDA’s requests was "final" and "complete."

" This indictment demonstrates that those who purposely subvert the regulatory functions of the FDA through false statements and misleading information will be held accountable for their deception," stated Dara Corrigan, FDA’s Associate Commissioner for Regulatory Affairs.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison. 
 

USA Today had an interesting and controversial article on two new studies that show the bones of some post-menopausal women who take bisphosphonates (Actonel, Boniva, Fosamax, Reclast) to ward off osteoporosis can stop rejuvenating and become brittle after prolonged use.   Bisphosphonates are among the top-selling drugs in the USA,with annual sales exceeding $3.5 billion.

Osteoporosis is a health risk for the aging population. An estimated 10 million Americans have the disease and almost 34 million have low bone mass, putting them at risk for spine and hip fractures.   Studying bone biopsies in women who suffered femur fractures, lead researcher Dr. Joseph Lane found the quality of the bone diminished after long-term bisphosphonate use.

 

 

Dr. Rosenwasser’s research notes that bone densitometry (DXA) scans show a buckling potential in the femur area of the hip in patients being treated for osteoporosis with bisphosphonates. His studies note the decline after four years of use or more. "It can be thought of as a brittleness," Rosenwasser says. "Think of it as not a lack of quantity of bone mineral but of quality of organization."

 

This is a well-written editorial from the New England Journal of Medicine discussing why it is important to preserve people’s rights to bring tort actions. It is written by the editor of the NEJM himself.
http://content.nejm.org/cgi/content/full/359/1/1?query=TOC

Volume 359:1-3 July 3, 2008 Number 1
Why Doctors Should Worry about Preemption
Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. 

A leading drug company may be poised to win a landmark legal victory next fall. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine),1 drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective.

A medical-device company won such a victory in April. In Riegel v. Medtronic,2 the Supreme Court determined that a product-liability lawsuit against Medtronic in a state court was preempted because the device had received FDA approval. Preemption is a legal doctrine based on the supremacy clause of the U.S. Constitution, which states that when federal and state laws are at odds, federal law takes precedence. Its application to state tort litigation is a radical extension of its original meaning.

Medtronic won its case because the 1976 law that grants the FDA authority to regulate medical devices contains a clause asserting that state requirements with regard to medical devices are preempted by federal requirements. Although the preemption clause is silent on common-law tort actions, the Supreme Court (with Justice Antonin Scalia writing for the Court) interpreted the preemption clause broadly to include such actions.

Unlike the law governing medical devices, the Food, Drug, and Cosmetic Act, which provides the statutory framework for the regulation of drugs by the FDA, contains no such preemption clause. Thus, in Wyeth v. Levine — which concerns a patient who lost her arm after an injection of Wyeth’s antiemetic drug Phenergan — the Court will decide whether preemption of state tort litigation is implied by the law, even though it is not explicitly stated.

Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA’s regulatory actions and enhance patient safety. Margaret Jane Porter, former chief counsel of the FDA, wrote, "FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."3 Persons who are harmed have the right to seek legal redress. Preemption would erase that right.

But in the past few years, the government’s views have shifted, and the FDA has reversed its position, now claiming that common-law tort actions are preempted. The FDA argues that tort liability stifles innovation in product development and delays the approval process, and that lay juries are incapable of making determinations about product safety. It has been argued, however, that Congress, not unelected appointees of a federal agency, has the power to decide whether preemption should apply.

Drug and device companies have chosen an inauspicious moment to attack the right of patients to seek redress. A series of pivotal reports on patient safety from the Institute of Medicine, as well as numerous articles in scholarly journals, has put the issue of patient safety in the national spotlight. Although frivolous lawsuits should not be condoned, product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it. Through the process of legal discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety.

Owing in part to a lack of resources, approval of a new drug by the FDA is not a guarantee of its safety (see timeline).4 As the Institute of Medicine has reported, FDA approval is usually based on short-term efficacy studies, not long-term safety studies.5 Despite the diligent attention of the FDA, serious safety issues often come to light only after a drug has entered the market. The FDA, which — unlike most other federal agencies — has no subpoena power, knows only what manufacturers reveal.

Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere.

In May, a Congressional hearing on preemption was held by Representative Henry Waxman (D-CA) and the House Committee on Oversight and Government Reform. As we stated in our testimony to the committee, to ensure the safety of medical devices, we urge Congress to act quickly to reverse the Riegel decision. Congressman Waxman and Congressman Frank Pallone, Jr. (D-NJ), are poised to introduce legislation that would unambiguously eliminate the possibility of preemption of common-law tort actions for medical devices. And if the Supreme Court rules for preemption in Wyeth v. Levine, which we hope it will not, Congress should consider similar legislation for drugs. Such legislation is in the best interest of the health and safety of the American public.

Dr. Curfman is the executive editor, Dr. Morrissey the managing editor, and Dr. Drazen the editor-in-chief of the Journal.   An interactive timeline is available with the full text of this article at www.nejm.org.

References

1. Wyeth v. Levine, cert. granted, 128 S. Ct. 1118 (2008).
2.  Riegel v. Medtronic, 128 S. Ct. 999 (2008).
3..Porter MJ. The Lohr decision: FDA perspective and position. Food Drug Law J 1997;52:7-11. [ISI][Medline]
4.  Kessler DA, Vladeck DC. A critical examination of the FDA’s efforts to preempt failure-to-warn claims. Georgetown Law J 2008;96(2). (Accessed June 13, 2008, at  http://lsr.nellco.org/georgetown/ois/papers/2/.)
5. Baciu A, Stratton K, Burke SP, eds. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press, 2007.